COVID-19 Resources & Updates
Clinical Trials Ontario is committed to helping advance COVID-19 research and clinical trials as quickly and effectively as possible by connecting the clinical trials community, sharing relevant information, and getting studies off the ground efficiently. On this page, you will find helpful resources, relevant news items, Health Canada approved COVID-19 studies, and a list of COVID-19 trials using CTO Stream.
CTO can help you move COVID-19 studies forward quickly
Through CTO’s programming, CTO Stream, the Trial Site Network, and QuickSTART, we can help identify collaborators across the province and assist in managing study start-up at each of these centers. Read more about how we can help you move forward, faster here.
News and Resources
- CTO Stream’s Response to COVID-19
- Regulatory updates for the clinical trials community
- News from the clinical trials community
- CanCOVID initiative
- COVID Resources for Industry
Active Research Projects
COVID-19 Clinical Trials in CTO Stream
This list includes COVID-19 clinical trials, interventions or observational studies within the CTO Stream program. This list is intended to facilitate connections between the clinical trials community to accelerate COVID-19 research in Ontario. If you would like more information on these trials, please email info@ctontario.ca.
A Multi-centre, Adaptive, Randomized, Open-label, Controlled Clinical Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Patients (CATCO)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical trial |
| Lead Site: | Sunnybrook Health Sciences |
| Lead Investigator: | Rob Fowler |
| Study Sponsor: | Sunnybrook Research Institute |
| Study Contact Information: | Gail Klein |
| Multi-site Study: | Yes |
| Lay Summary | This study aims to evaluate the efficacy and safety of different treatments compared to standard of care of patients hospitalized for COVID-19. The first treatment to be assesses is lopinavir/ritonavir, a common retroviral drug. Participants will be randomized to receive either standard-of-care products or the study medication, while being hospitalized for COVID-19.
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| Clinicaltrials.gov link | https://clinicaltrials.gov/ct2/show/NCT04330690?term=catco&draw=2&rank=1 |
COVID-19 Ring-based Prevention trial with Lopinavir/ritonavir (CORIPREV LR)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | No |
| Study Type: | Clinical Trial |
| Lead Site: | St. Michael’s Hospital |
| Lead Investigator: | Darrell Tan |
| Study Sponsor: | St. Michael’s Hospital |
| Study Contact Information: | Attia Qamar |
| Multi-site Study: | Yes |
| Lay Summary | Despite efforts to contain it, the rapidly expanding global pandemic necessitates the rapid evaluation of strategies for prevention of COVID-19 in close contacts of new cases. Lab data, animal models and early clinical data suggest that a drug commonly used to treat HIV, called Kaletra, may have activity against COVID-19 and its closely related cousin coronaviruses, SARS and MERS. Kaletra is currently being tested in clinical trials in China for treatment. This drug has been safely used for over two decades in HIV treatment and also in post-exposure prophylaxis (PEP) for un-infected people with high-risk exposures. Our study will address the immediate need for prevention interventions by testing whether or not giving Kaletra PEP to contacts exposed to COVID-19 will stop them from getting the disease. Our trial employs a commonly used approach in vaccination studies called a ring design, which also allows us to collect detailed information about the natural history of the infection in exposed contacts. In addition to testing the effectiveness of our specific intervention, the master protocols and procedures developed can be used to test other prevention interventions including both medications and vaccines, once they become available. This ring design was a key part of the successful eradication of smallpox, and the evaluation of the vaccine used for Ebola. We will identify a ring of exposed close contacts around index cases and randomize these rings to a 14-day course of Kaletra PEP or no intervention and will test them systematically to see if they develop COVID-19. Our study team members of Canadian experts on the frontlines with SARS, MERS, H1N1, Ebola, and HIV, are well connected to coordinate with existing clinical trials networks both in Canada and internationally. |
| Clinicaltrials.gov link | https://clinicaltrials.gov/ct2/show/NCT04321174?term=CORIPREV+LR&draw=2&rank=1 |
Anti-Coronavirus Therapies to prevent COVID-19 progression (ACT) Trial
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | Hamilton Health Sciences Corporation |
| Lead Investigator: | Richard Whitlock |
| Study Sponsor: | Hamilton Health Sciences Corporation |
| Study Contact Information: | ACT Project Team |
| Multi-site Study: | Yes |
| Lay Summary | A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected hundreds of thousands of people worldwide. The disease that is now known as COVID-19 was first reported to the World Health Organization on December 31, 2019. The disease is spreading quickly around the globe and has been declared a pandemic on March 11, 2020. Exploring therapies potentially of benefit for COVID-19 is a public health emergency.
This program will determine whether the combination of chloroquine and azithromycin reduces the primary outcome of clinical progression of COVID-19. The program consists of 2 parallel trials in people who have tested COVID-19 positive; 1) the outpatient trial, and 2) the inpatient trial. |
| Clinicaltrials.gov link | https://clinicaltrials.gov/ct2/show/NCT04324463?term=Anti-Coronavirus+Therapies+to+prevent+COVID-19+progression+%28ACT%29+Trial&draw=2&rank=1 |
How are you coping? Assessing the psychological, social, and economic impacts of an emerging pandemic (C19 Survey)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | The Royal Institute of Mental Health Research |
| Lead Investigator: | Rebecca Robillard |
| Study Sponsor: | |
| Study Contact Information: | Rebecca Robillard |
| Multi-site Study: | Yes |
| Lay Summary | The outbreak of COVID-19 was declared a pandemic by the World Health Organization on 11 March 2020. In response to this outbreak, most hospitals have cut down non-essential services and most staff is working under unusual circumstances; several offices and business have closed, some asked their employees to work from home, others reduced work hours or terminated jobs; schools and universities have been closed. Stock markets are highly unstable and some geographical borders are being closed. The general population is encouraged to self-isolate in order to limit the spread of the virus. At the moment, the duration of the outbreak is still unknown, and as such, people are uncertain as to when and how they may be able to resume normal life. The current situation unfolding with regards to the COVID-19 virus is changing core aspects of peoples lives in a unique manner.
This study aims to examine the psychological, social, and financial impacts of the COVID-19 pandemic at various stages of the outbreak. Special attention is given to social isolation, as well as family and work related factors.
An online survey will be distributed via multiple hospitals, web-based platforms and social media in the early phase of the outbreak. The survey includes validated questionnaires and custom-made questions to asses the current situation. It addresses the following core themes: demographics, COVID-19 symptoms, social distancing and social interactions, as well as physical and mental health. Respondents have the option of being followed at different stages across the crisis. The survey also includes targeted questions for individuals with a current diagnosis of a mental/medical illness, as well as health care providers and health care administrative staff. |
| Clinicaltrials.gov link |
Protecting Frontline Health Care Workers from COVID-19 with Hydroxychloroquine Pre-exposure Prophylaxis: A Randomized, Placebo-controlled Multi-Site Trial in Toronto, Canada (HEROs Trial)
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | No |
| Study Type: | Clinical trial |
| Lead Site: | University Health Network |
| Lead Investigator: | Megan Landes |
| Study Sponsor: | University Health Network |
| Study Contact Information: | E. Fremes |
| Multi-site Study: | Yes |
| Lay Summary | On March 11, 2020, the World Health Organization declared SARS-CoV-2 (commonly called COVID-19) a global pandemic. As in any pandemic, maintaining the health and safety of the healthcare workforce is of great importance as health care workers (HCW) remain a critical line of defence against the spread of COVID-19 and play a vital role in the recovery of those already infected. Frontline HCW, such as those in the emergency department (ED), are at high risk of contracting COVID-19 due to their close proximity to patients who may have the virus. The impact of frontline HCW becoming ill and thus unable to go to work is equally high, and of grave risk to the function of our healthcare system and our ability to minimize the impact of the current pandemic. This study aims to evaluate whether hydroxychloroquine (HCQ), a well-tolerated drug typically used in the prevention of malaria transmission and rheumatic disease, taken before and during exposure to patients with COVID-19 is effective in reducing COVID-19 infections among ED HCW. We will enroll ED HCW from 5 hospital sites in Toronto, Canada in this trial, and randomly give half of the group HCQ and the other half a placebo pill for 90 days and compare the number of people in each group that are infected with COVID-19. Throughout the trial we will monitor each group with 4 visits, where we will monitor if the drug is safe and tolerable, the ability of participants to take the medication regularly, as well as their psychological well-being. This study, if shown successful, has the potential to greatly benefit the health system on an individual, institutional, national, and international level.
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| Clinicaltrials.gov link |
Altered sense of smell and distorted taste as cardinal symptoms of COVID-19 using subjective and self-reported objective measures
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | St. Michael’s Hospital |
| Lead Investigator: | John Lee |
| Study Sponsor: | |
| Study Contact Information: | Daniel Lee |
| Multi-site Study: | Yes |
| Lay Summary | Background: Coronavirus disease 2019 (COVID-19) is known to spread widely and rapidly. Currently, the symptoms used for screening include high temperature (fever), cough, shortness of breath, sore throat and/or runny nose. There is emerging anecdotal evidence that up to 30% of patients with COVID-19 may have complete or partial loss of smell and/or distortion of taste as early symptoms. However, there is lack of systemic evidence that smell and taste are disturbed in patients with COVID-19. Objective: To assess the prevalence of loss of smell and distorted taste in patients who are tested or self-isolated for suspected COVID-19. Methods: The study is designed as multi-centre cross-sectional surveys with two phases. The first phase targets subjects who have already visited COVID-19 Assessment Centres for suspected COVID-19. Subjects are identified from the list of patients at COVID-19 Assessment Centres. In the second phase, subjects visiting COVID-19 Assessment Centres for query COVID-19 are prospectively recruited. In both phases, subjects participate in online surveys on a voluntary basis. The survey collects information on demographics, and co-morbidities. Participants are asked about diagnosis, timing, and symptoms of suspected or positive COVID-19. Lastly, participants are asked questions on subjective assessment on change in smell and taste. In the second phase only, the survey includes self-reported objective assessment of smell and taste using common household items. Primary outcome would be the prevalence of subjective anosmia, hyposmia and/or dysgeusia as symptoms among patients with COVID-19 compared with patients without COVID-19. Significance: The results from our study would lead to expansion of screening criteria with the addition of smell and taste. This will be a simple and inexpensive public health intervention to risk stratify individuals who may be otherwise asymptomatic, raise public awareness and ultimately reduce community transmission of COVID-19. |
| Clinicaltrials.gov link |
Post-exposure Prophylaxis or Preemptive Therapy for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial (COVID-19 PEP RCT - Canada)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical trial |
| Lead Site: | St. Joseph’s Healthcare Hamilton |
| Lead Investigator: | Zain Chagla |
| Study Sponsor: | St. Joseph’s Healthcare Hamilton |
| Study Contact Information: | Seema Nair Parvathy |
| Multi-site Study: | |
| Lay Summary | The purposes of this study are: 1- To determine if giving hydroxychloroquine for five days to individuals who have been exposed to COVID-19 will prevent COVID-19 disease. 2- To determine if giving hydroxychloroquine for five days to individuals with early proven or possible COVID-19 will reduce the severity of symptoms |
| Clinicaltrials.gov link | https://clinicaltrials.gov/ct2/show/NCT04308668?term=NCT04308668&draw=2&rank=1
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ExtraCorporeal Membrane Oxygenation for 2019 novel Coronavirus Acute Respiratory Disease (The ECMOCARD Study)
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | University Health Network – Toronto General Hospital |
| Lead Investigator: | Eddy Fan |
| Study Sponsor: | University of Queensland |
| Study Contact Information: | Kathleen Exconde |
| Multi-site Study: | Yes |
| Lay Summary | In late December, 2019, in Wuhan, Hubei Region, China, a new respiratory syndrome emerged with clinical signs resembling viral pneumonia and person-to-person transmission. Samples from lower respiratory tract, corroborated emergence of a novel coronavirus, namely the 2019 novel coronavirus (2019-nCoV). In particular, several patients with pneumonia of unknown cause were in Wuhan on December 21, 2019 or later, and who had been present at the Huanan Seafood Market. Thus far, more than 111,000 confirmed cases, including health-care workers, have been identified worldwide, and several exported cases have been confirmed in other provinces in China, Thailand, Japan, South Korea, Germany, Italy, France, Iran, USA and many other countries. An early case report in 41 patients with laboratory-confirmed COVID-19 infection in Wuhan has been reported. The median age of the patients was 49 years and mostly men (73%). Among those, 32% were admitted to the intensive care unit. In a later retrospective report by Wang and collaborators, clinical characteristics of 138 patients with COVID-19 infection were described. Those patients were admitted at Zhongnan Hospital of Wuhan University in Wuhan, China, from January 1 to January 28, 2020. The median age was 56 years and admission to the intensive care unit was required in 26.1% and 47.2% required mechanical ventilation.
Unfortunately, these initial clinical reports provide marginal characterization of patients who are admitted to the intensive care unit and require mechanical ventilation or other highly invasive procedures such as extracorporeal membrane oxygenation (ECMO) to support the failing lungs.
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| Clinicaltrials.gov link |
RUX-COVID: A single arm open-label clinical study to investigate the efficacy and safety of RUXolitinib for the treatment of COVID-19 pneumonia
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical trial |
| Lead Site: | Princess Margaret Cancer Centre |
| Lead Investigator: | Steven Chan |
| Study Sponsor: | University Health Network |
| Study Contact Information: | Bonnie Kwan |
| Multi-site Study: | Yes |
| Lay Summary | This is a study to see how safe and effective the drug ruxolitinib is for the treatment of COVID-19 pneumonia. This will be determined by seeing how many participants subsequently become critically ill (requiring mechanical ventilation and/or have fraction of inspired oxygen (FiO2) of 60% or more). |
| Clinicaltrials.gov link | https://clinicaltrials.gov/ct2/show/NCT04331665?term=RUX-COVID&draw=2&rank=1
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Risk of death or respiratory failure in patients with COVID-19 who received an ACE inhibitor, ARB, or NSAID: An International Multicentre Cohort study [COVID-ACE/ARB/NSAID] (COVIDACE)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | Sinai Health System |
| Lead Investigator: | Michael Fralick |
| Study Sponsor: | |
| Study Contact Information: | Alexi Gosset |
| Multi-site Study: | Yes |
| Lay Summary | The coronavirus disease 2019 (COVID-19) has infected over 800,000 people worldwide and claimed the lives of nearly 40,000 at the time of writing. Preliminary data suggest that certain medications might be associated with worse outcomes, however, these data are conflicting and not based on clinical evidence. The medications include angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARB) (both of which are medications commonly used for elevated blood pressure) and non-steroidal anti-inflammatory drugs (NSAIDS). We will conduct a multicenter cohort study of adults 40 years and older who received these medications (i.e., ACE, ARB, NSAIDS) prior to the hospitalization for COVID19 and we will compare outcomes to adults who received other medications prior to the hospitalization for COVID19. The primary outcome of the study includes death, respiratory failure, or transfer to the intensive care unit. |
| Clinicaltrials.gov link |
A Research Platform to Screen and Protect Healthcare Workers (U-DEPLOY: RESPECT)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | Toronto General Hospital |
| Lead Investigator: | Depali Kumar |
| Study Sponsor: | University Health Network |
| Study Contact Information: | Bonnie Kwan |
| Multi-site Study: | Yes |
| Lay Summary | This is a point prevalence study to determine the rate of asymptomatic shedding of SARS-CoV-2 in healthcare workers (HCWs).
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| Clinicaltrials.gov link |
A Randomized, Open-Label Trial of CONvalescent Plasma for Hospitalized Adults With Acute COVID-19 Respiratory Illness (CONCOR-1)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | Hamilton Health Sciences Centre |
| Lead Investigator: | Donald Arnold |
| Study Sponsor: | McMaster Centre for Transfusion Research (MCTR); McMaster University |
| Study Contact Information: | Chantal Armali |
| Multi-site Study: | Yes |
| Lay Summary | This is a point prevalence study to determine the rate of asymptomatic shedding of SARS-CoV-2 in healthcare work
COVID-19 is an illness caused by a new virus. This virus causes more severe symptoms than most other respiratory viruses, thus treatments are urgently needed for those who become significant ill from it. Currently there is no proven cure for COVID-19, and treatment consists of supportive care while patients hopefully recover. However, there have been preliminary studies showing promise for specific treatments that may increase the likelihood of recovery. One such treatment is convalescent plasma, which is a blood product obtained from people who have recovered from COVID-19. This study aims to definitively determine whether or not convalescent plasma is effective at treatment patients significantly ill with COVID-19. Patients who have recovered from COVID-19 will be identified and recruited to donate their plasma. We will then randomly select certain hospitalized COVID-19 patients to receive this convalescent plasma, and compare their health outcomes with similar patients who did not receive this treatment. |
| Clinicaltrials.gov link |
A Research Platform to Screen Patients in Oncology and Assess Impact (U-DEPLOY: RESPONSE)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | Princess Margaret Cancer Centre |
| Lead Investigator: | Stephanie Lhereux |
| Study Sponsor: | University Health Network |
| Study Contact Information: | Bonnie Kwan |
| Multi-site Study: | Yes |
| Lay Summary | The purpose of this study is to look at the rate of asymptomatic COVID-19 infection in cancer patients receiving cancer therapy.
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| Clinicaltrials.gov link |
National CVA COVID Study
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | University Health Network |
| Lead Investigator: | Aleksandra Pikula |
| Study Sponsor: | University Health Network |
| Study Contact Information: | William To |
| Multi-site Study: | Yes |
| Lay Summary | COVID-19 is a global pandemic crisis and it poses significant health risks to the world and the national community, while its landscape is still rapidly evolving. As of April 8, 2020, world has 1.45 million confirmed COVID-19 case, while Canada has 18,465 and ~ 30% of all are in Ontario (n=5,276), 52% are female, and 35% are 60 yrs or older (Ontario.ca). Pre-existing vascular risk factors and cardiovascular disease have emerged as risk factors for severity of COVID-19 related illness1-3. Although there are limited reports on incidence of cerebrovascular disease in COVID-19 patients, the pandemic surge is posing two major questions to the global cerebrovascular community:
Question 1: Could COVID-19 infection be complicated by cerebrovascular events and if so, what are the risks, management options and outcomes in these patients? Question 2: Could COVID-19 surge affect the delivery of cerebrovascular care to non-infected patients? The National CVA COVID Study is a 2020 pan-Canadian cohort study for cerebrovascular patients (and healthcare workers) with and without COVID-19 in the delivery of clinical care. Our pragmatic 1 year, two-tiered prospective cohort study is supported under a rapid COVID-19 institutional research umbrella (REB/CTO) at 13 participating Canadian centers. All national sites will also participate in a Stroke-COVID national survey that will assess the mental well-being of healthcare workers (HCW) involved in the care of stroke patients. The results of our study will accelerate the flattening of the curve in the fight against the COVID-19 pandemic.
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| Clinicaltrials.gov link |
Pandemic Response Biobank for Coronavirus Samples (U-Deploy: PRESERVE)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | University Health Network |
| Lead Investigator: | Shahid Husain |
| Study Sponsor: | University Health Network |
| Study Contact Information: | Sarbjot Gill |
| Multi-site Study: | Yes |
| Lay Summary | To establish a biorepository of biospecimens with the breadth and depth of accompanying clinical data for future research. |
| Clinicaltrials.gov link |
Progression and predictors of myocardial injury in resolved COVID-19 patients (COVID-19)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | SBHSC |
| Lead Investigator: | Idan Roifman |
| Study Sponsor: | SHSC |
| Study Contact Information: | Mary Li |
| Multi-site Study: | Yes |
| Lay Summary | The ongoing 2019 coronavirus disease (COVID-19) pandemic has been responsible for unprecedented worldwide morbidity and mortality. Myocardial injury is emerging as a potential major contributor of mortality in COVID-19 patients. However, the etiology of the myocardial injury (myocardial infarction, myocarditis or cardiomyopathy) is unknown as are its progression and its predictors. Cardiac magnetic resonance imaging (CMR) is able to differentiate between the three etiologies in an accurate and reliable manner. This grant will harness CMR in order to evaluate the prevalence, progression and predictors of myocardial injury in patients who have recovered from COVID-19 infection. In order to do this we will prospectively recruit a cohort of 75 patients who have recovered from COVID-19 infection from four U of T affiliated hospitals: Sunnybrook Health Sciences Centre, University Health Network, St. Michaels Hospital and Southlake Hospital, collect baseline clinical characteristics on them and perform serial MRI scans at three time points at Sunnybrook with a streamlined protocol optimized to address challenges in this population. Knowledge derived from our grant will shed light onto the prevalence and nature of myocardial injury associated with Covid-19 infection and help identify the patients most likely to develop it. The project also has the potential to reduce downstream hospitalizations for heart failure thus reducing the demand on soon-to-be overloaded healthcare systems. Finally, these data will also serve as pilot data for larger future studies which will evaluate the long-term prognosis of patients with myocardial injury by evaluating longer term clinical outcomes. |
| Clinicaltrials.gov link |
REMAP-CAP (Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Patients with Community Acquired Pneumonia)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | St. Michael’s Hospital |
| Lead Investigator: | John Marshall |
| Study Sponsor: | St. Michael’s Hospital |
| Study Contact Information: | Zahra Bhimani |
| Multi-site Study: | Yes |
| Lay Summary | https://static1.squarespace.com/static/5cde3c7d9a69340001d79ffe/t/5e7aa683864e9b0fbecf9c54/1585096325159/REMAP-CAP+essentials+-+24+March+2020.pdf
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| Clinicaltrials.gov link | https://clinicaltrials.gov/ct2/show/NCT02735707
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Awake Prone Position in Hypoxemic Patients with Coronavirus Disease 19 (COVI-PRONE): A Randomized Clinical Trial
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | Research Institute of St. Joseph’s; Healthcare Hamilton |
| Lead Investigator: | Waleed Alhazzani |
| Study Sponsor: | The Research Institute of St. Joe’s Hamilton |
| Study Contact Information: | S. Culgin |
| Multi-site Study: | Yes |
| Lay Summary | While prone position for > 12 hours reduces mortality in intubated ARDS patients; recent non-randomized evidence suggests that awake proning in non-intubated ARDS patients improves oxygenation, but the effect on other patient-important outcomes is uncertain. Early awake proning is a simple intervention that can be done in most institutions. We propose a protocol for a randomized controlled trial is to determine if early prone positioning in patients with COVID-19 and hypoxemic respiratory failure can reduce the need for invasive mechanical ventilation. The COVI-PRONE trial will be a multicenter, parallel-group randomized controlled trial (RCT) that will take place at several centers across Canada, USA, Saudi Arabia, and potentially other international sites.
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| Clinicaltrials.gov link |
Post discharge after surgery Virtual Care with Remote Automated Monitoring technology (PVC-RAM) Trial
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | Hamilton Health Sciences Corporation |
| Lead Investigator: | PJ Devereaux |
| Study Sponsor: | Hamilton Health Sciences Corporation |
| Study Contact Information: | Valerie Harvey |
| Multi-site Study: | Yes |
| Lay Summary | The PVC-RAM trial will evaluate the use of virtual care (e.g., video visits with a study nurse) and remote automated monitoring technologies (e.g., blood pressure cuff readings transmitted to virtual nurses) during emergency situations, such as the COIVD-19 pandemic, to decrease the number of hospital readmissions, emergency room and urgent care visits in the first 30 days after discharge by patients that have undergone semi-urgent, urgent or emergency surgery. In this trial, participants will be taught how to use a tablet computer and monitoring devices in their home. Participants will measure vital signs (such as blood pressure, heart rate and temperature) daily, as well as responding to surveys that will assist virtual care nurses in assessing their recovery. Patients will interact with a virtual care nurse by video, daily on days 1-15 after hospital discharge, and every other day from days 16-30. On days without planned virtual visits, nurses will organize unscheduled video visits if they detect changes in patient vital signs or recovery survey responses that require follow up. During virtual visits, the nurse will discuss any symptoms the patient is experiencing, evaluate their wound and obtain a picture, reinforce principles related to recovery after surgery and the need for physical distancing, and undertake medication review and reconciliation. If the patients vital sign measurements show changes that require intervention by a health care provider, the patient reports specific symptoms (e.g., shortness of breath), a medication error is identified, or the virtual nurse has concerns about the patients health, the virtual nurse will escalate care to a pre-assigned and available physician (i.e., the patients surgeon or a study medical physician). Via secure video or text messaging, patients will also have access to a virtual nurse at night, for any urgent issues.
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| Clinicaltrials.gov link |
Randomized clinical trial of Acai Palm Berry extract as an intervention in patients diagnosed with COVID-19 (Palm Berry extract in COVID-19 patients)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | University Health Network |
| Lead Investigator: | Michael Farkouh |
| Study Sponsor: | University of Toronto – Department of Pharmacology |
| Study Contact Information: | Hassan Ellaban |
| Multi-site Study: | Yes |
| Lay Summary | The current COVID-19 pandemic is caused by the novel coronavirus (SARS-Cov-2). The virus causes many disturbances in the human body, including excessive inflammation. Preliminary studies have indicated that the natural extract of Acai Palm Berry may act as an inhibitor of inflammation, which is yet to be confirmed in humans. Other conventional drugs that are being tested against COVID-19, such as colchicine, and hydroxychloroquine, also inhibit the same inflammation pathways as Acai Palm Berry does. The extract of the Acai Palm Berry is a safe, inexpensive, and readily available natural health supplement which could be a rapid response treatment intervention for patients with COVID-19. The purpose of this research study is to test if the extract of the Acai Palm Berry will improve recovery of patients with COVID-19. More specifically, this research will investigate if the extract of the Acai Palm Berry can reduce mortality or need of mechanical ventilation in patients with COVID-19. Of note, currently there is no proven therapy that could be used in the treatment of these patients. The usual treatment of your disease (COVID-19) is limited to supportive care and no specific intervention has proved efficacy against COVID-19 so far. The extract of the Acai Palm Berry is available in Canada as an over-the-counter natural product and has not yet showed efficacy against COVID-19 and should be used with this purpose only within a clinical study. We will recruit participants diagnosed with COVID-19, are 40 years or older, and are being treated either at home or in a hospital room or ward, but not in the intensive care unit. The extract of the Acai Palm Berry is experimental for COVID-19. Experimental means Health Canada has not approved the sale or use to treat COVID-19 but they have approved its use in this research study.Up to 240 people will participate in this study with up to 120 at UHN and the all Toronto sites.It should take 6 months to complete. |
| Clinicaltrials.gov link |
A National Registry to address knowledge gaps in emergency management for patients presenting during the COVID-19 pandemic (Canadian Emergency Department COVID-19 Registry)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | Queen’s University/ Kingston Health Sciences Centre |
| Lead Investigator: | Steven Brooks |
| Study Sponsor: | |
| Study Contact Information: | laod |
| Multi-site Study: | Yes |
| Lay Summary | Emergency physicians on the front line responding to the Coronavirus Disease 2019 (COVID-19) pandemic are preparing to intervene with very little evidence to guide management. Based on global data, 20% of COVID-19 patients are admitted to hospital with the vast majority being discharged home. We propose a national Emergency Department (ED) COVID-19 registry to gather data through medical record review and follow-up telephone interviews on potential and confirmed COVID-19 patients treated in urban and rural EDs in Ontario. We will use the national registry data iteratively to identify risk factors and predictors associated with poor patient outcomes including the need for non-invasive ventilation, high flow oxygen therapy, intubation, mechanical ventilation, and ICU admission. We will derive clinical decision rules that can be prospectively validated in network EDs to create a rapid cycle knowledge translation mechanism and optimize patient outcomes. We will include all suspected and confirmed COVID-19 positive patients without exclusion. Research assistants will collect the data through remote access and will obtain verbal consent for telephone interviews similar to what is occurring currently for virtual medicine.
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| Clinicaltrials.gov link |
Assessing the mother-to-infant transmission capabilities of COVID-19 infection among pregnant women in Ontario, Canada (The COVID-19 Ontario Pregnancy Event (COPE) Network)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | Ottawa Hospital Research Institute |
| Lead Investigator: | Darine El-Chaar |
| Study Sponsor: | Ottawa Hospital Research Institute |
| Study Contact Information: | R. Fakhraei |
| Multi-site Study: | Yes |
| Lay Summary | In order to assess the mother-to-infant and potential vertical transmission of SARS-CoV-2 infection in pregnant women, maternal and neonatal biological samples will be prospectively collected from women with confirmed or suspected COVID-19 at participating hospitals across Ontario. Samples will be tested for the SARS-CoV-2 serology and viral load.
The study population will consist of pregnant women with confirmed or suspected COVID-19 at any point during pregnancy, who will be delivering at a participating hospital within Ontario and agree to provide maternal and/or neonatal samples. Outcomes for the study objective will be ascertained through the collection and testing of biological samples from the mother and/or infant. Specifically we will:
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| Clinicaltrials.gov link |
Hearing and Supporting the Healthcare Workers: Mental Health Outcomes in Healthcare Workers during COVID-19 (MHW-COVID-19)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | University Health Network |
| Lead Investigator: | Rima Styra |
| Study Sponsor: | University Health Network |
| Study Contact Information: | Rima Styra |
| Multi-site Study: | Yes |
| Lay Summary | Previous work conducted by our group during the 2003 SARS outbreak demonstrated symptoms of post-traumatic stress disorder (PTSD) and depression in healthcare workers (HCWs) working in high-risk areas. Similar reports are emerging with regards to HCWs during COVID-19 which may affect staff absenteeism, burnout. and retention. This study will evaluate the psychological impact of the COVID-19 pandemic on frontline hospital HCWs and identify risk factors that may place HCWs at greater risk. Toronto is in the unique situation of having been at the centre of the 2003 Canadian SARS outbreak and presently experiencing the impact of the COVID-19. We believe COVID-19 might have a differential impact on the psychological wellbeing of current HCWs depending on whether they practiced during SARS. We postulate these HCWs are more likely to have a resurgence of intrusive distressing memories of past events, avoidance of triggering situations, and negative alterations in cognition and mood. It is important to determine whether HCWs who had worked during SARS are experiencing distress-associated symptoms during the present pandemic which may impede their ability to be effective and therefore in need of greater assistance. A survey will be sent to HCWs in TASHN hospitals to explore perceptions of risk to self and family, and levels of anxiety, depression and post-traumatic stress symptoms using validated scales. Understanding the factors that result in negative psychological impact on HCWs during this pandemic will enable the development and rollout of support and mitigation strategies. Addressing and supporting the needs of our HCW colleagues will in turn allow them to be more present to address the needs of our patients. |
| Clinicaltrials.gov link |
The Ontario COVID-19 Prospective Cohort Study
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | University Health Network |
| Lead Investigator: | Angela M Cheung |
| Study Sponsor: | |
| Study Contact Information: | contact |
| Multi-site Study: | Yes |
| Lay Summary | In December 2019, a novel coronavirus (COVID-19)infected pneumonia was identified in Wuhan, China, and is a current global pandemic. Early studies are emerging, but it is still unclear what may determine better or worse outcomes for these patients and their caregivers, and what the long-term consequences that having this virus might be. COVID-19 leads to severe respiratory, cardiac, neurologic and kidney complications that may warrant hospital and ICU admission. Current data suggests that 80-85% of people infected with COVID-19 have mild symptoms and are not hospitalized. Of those who are hospitalized, 60-80% will be discharged from hospital after a few days, and 20-40% may require ICU care and mechanical ventilation (approximately 4-6% of all COVID-19 positive patients). The determining factors of these varied clinical paths are urgently needed and unknown.
Our investigator group is proposing an Ontario COVID-19 Prospective Cohort Study (OnCovP). This will be a multi-centre, one-year follow-up of COVID-19 patients who are hospitalized in acute care hospitals in Ontario. Our overall objectives are to determine short- (in hospital) and longer-term (1, 3, 6 and 12 months post-acute hospital discharge) outcomes in patients and their caregivers, and the clinical, sociodemographic, genetic/ transcriptomic/epigenomic predictors of these outcomes. Our overall hypothesis is that clinical risk factors (including but not limited to age, baseline health, socio-demographic status, comorbid illness and candidate genetic/transcriptomic/epigenomic risk factors) are determinants of short- and long-term outcomes in patients with COVID-19. We will prospectively recruit 500 consecutive patients (>age 16) who are COVID-19+ and admitted to hospitals in Ontario through the GEMINI (general internal medicine) and RECOVER (critical care) networks of investigators, as well as their caregivers. By leveraging expertise from investigators across disciplines and divisions, we have constructed a suite of five complementary projects that explore the genetic, transcriptomic and epigenomic evaluation of COVID-19 infection across the illness and recovery trajectory during the acute illness and in the context of multidimensional long-term outcomes. We will access electronic data through the GEMINI network, and explore AI analyses and linkages to ICES data. This project will contribute new knowledge to outcomes in patients with COVID-19 infections and will inform large-scale public health planning, clinical care, and ongoing resource needs.
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| Clinicaltrials.gov link |
Covidfree@home
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | University Health Network |
| Lead Investigator: | Robert Wu |
| Study Sponsor: | University Health Network |
| Study Contact Information: | contact |
| Multi-site Study: | Yes |
| Lay Summary | With the Covid19 pandemic threatening to overwhelm healthcare systems worldwide, a key strategy to mitigate the impact is management of individuals with milder disease safely at home in self-isolation. However, while people who have died and/or been cared for in the ICU or hospital have been well characterized, there is little information about the clinical course of people in the outpatient setting. Most notably, it is not known when to escalate to hospital care. The consequence of non-escalation when needed is significant patient morbidity and mortality, of escalation when not needed is unnecessarily overwhelmed hospitals. Our experts and others have noted that symptoms are a poor – and possibly late – indicator for deterioration. Objective markers such as oxygen saturation, respiratory rate and heart rate could improve this. Our goal is to use real-time remote home-based mobile monitoring to develop a prediction model to detect which Covid19 patients sent to isolate at home should be brought into hospital, while providing reassurance to the majority to prevent them from coming in. Our platform will have several other benefits – including being immediately available for clinical care, characterizing our patients to better meet their needs, and providing a platform to answer further research questions. Because our platform is run on widely available smartphones it can be quickly scaled to be used by other institutions to benefit and learn from COVID-19 patients everywhere.
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| Clinicaltrials.gov link |
Identifying atypical presentations of COVID-19 in older adults to enhance screening and detection (COVID-AP)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | Unity Health Toronto |
| Lead Investigator: | Jennifer Watt |
| Study Sponsor: | |
| Study Contact Information: | Eric Wong |
| Multi-site Study: | Yes |
| Lay Summary | The COVID-19 pandemic is associated with high rates of hospitalization and death in older adults (age 65 years). Older adults with acute illness often present atypically with a geriatric syndrome (e.g. delirium, falls, or functional decline) or without classic disease symptoms. The current screening criteria for COVID-19 rely on the presence of influenza-like illness (ILI) symptoms (cough, fever, shortness of breath), which can be blunted or absent in older adults. As a result, screening and diagnosis of COVID-19 in older adults may be delayed. This is a significant weakness in our ongoing containment strategy. Furthermore, delirium is an acute state of confusion in older adults that may be an atypical presentation of COVID-19. Agitation and aggression in COVID-19 patients with delirium may pose a risk to staff and other patients. Timely detection and treatment of delirium and other atypical presentations can improve outcomes and mitigate risk. Several geriatric medicine organizations issued guidelines regarding management of older adults with COVID-19 based on expert consensus. There are no published descriptive studies on the prevalence of atypical presentations in older adults with COVID-19. This data is crucial for screening, detection, and management of COVID-19 cases in hospital and long-term care (LTC).
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| Clinicaltrials.gov link |
SedAting With Volatile Anesthetics Critically Ill COVID-19 Patients in ICU (SAVE-ICU trial): Effects On Ventilatory Parameters And Survival.
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | Sunnybrook Health Sciences Centre |
| Lead Investigator: | Angela Jerath |
| Study Sponsor: | Sunnybrook Research Institute |
| Study Contact Information: | Angela Jerath |
| Multi-site Study: | Yes |
| Lay Summary | Around 1 in 4 COVID-19 patients suffer lung failure needing life-saving support from a breathing machine. Any patient needing this support requires drugs to keep them sleepy to be comfortable on this machine. Sleep is made possible by using drugs we give through a vein. Unfortunately, these drugs are in short supply worldwide due to the high number of COVID-19 patients needing these machines. Another way to provide sleep is by using gases that you breathe in as are used every day in operating rooms to perform surgery. These gases can also be used in intensive care units and may have several important benefits for patients and the hospital.Research shows they may reduce swelling in the lung and increase oxygen levels, which allows patients to recover faster and reduces the time spent on a breathing machine. In turn, this allows the breathing machine to be used again for the next sick patient. These drugs may also increase the number of patients who live through their illness. Inhaled agents are widely available and their use could dramatically lesson the pressure on limited drug supplies.This research is a study being carried out in a number of hospitals that will compare how well patients recover from this illness depending on which type of sedation drug they receive. We will evaluate the number who survive, their time spent on a breathing machine and time in the hospital. This study will have immediate benefits and provides a cheap and practical solution to the current challenges caring for patients and using hospital beds and breathing machines to the greatest benefit. Finally, this trial will be a team of experts in sedation drugs who care for COVID-19 patients who need lifesaving treatments. |
| Clinicaltrials.gov link |
Clinical course of COVID-19 positive cancer patients on or recently ceased checkpoint inhibitor therapy
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | London Health Sciences Centre |
| Lead Investigator: | Scott Ernst |
| Study Sponsor: | London Health Sciences Centre |
| Study Contact Information: | Morgan Black |
| Multi-site Study: | Yes |
| Lay Summary | As of the end of March 2020, 664,292 people had been infected worldwide, with a death rate of approximately 4.6%. The continuous rise in cases of COVID-19 will increase demand on already strained health services worldwide. Patients with severe illness develop acute respiratory distress syndrome (ARDS) and require intensive care unit (ICU) admission and oxygen therapy. An hyperinflammatory syndrome, characterized by increase of cytokines (eg IL-6), ferritin, erythrocyte sedimentation rate and low platelets, has been identified in a subset of these patients, and there is growing evidence that tocilizumab (anti-IL-6) may be beneficial in these cases. In this study, we seek to better understand the presentation, disease course, management and clinical outcomes of COVID-19 in cancer patients on immune checkpoint blockade. |
| Clinicaltrials.gov link |
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Prone positioning for patients on general medical wards with COVID-19: A multicenter pragmatic randomized trial [COVID-PRONE]
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | Unity Health & Mount Sinai Hospital |
| Lead Investigator: | Michael Fralick |
| Study Sponsor: | St Michael’s Hospital |
| Study Contact Information: | Mike Fralick |
| Multi-site Study: | Yes |
| Lay Summary | As of April 15, 2020, there were over 2 million cases of COVID19 and over 130,000 deaths worldwide. The symptoms of COVID-19 can progress from mild pneumonia to severe acute respiratory distress syndrome (ARDS) and intensive care admission. Prone positioning (a patient lying on their stomach) is sometimes used for ventilated patients, in particular, those with ARDS, to improve ventilation and oxygenation. However, prone positioning has not been studied in non-ventilated patients as a proactive treatment to prevent respiratory failure. For this reason, we are studying the impact of proactive prone positioning among non-ventilated patients hospitalized with COVID19. This may give us more information about how to prevent the worsening of respiratory symptoms. |
| Clinicaltrials.gov link |
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Surveillance of Short- and Long-term Outcomes of Infants Born to COVID-19 Positive Mothers: A Prospective Epidemiological Study (COVID19outcomes)
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | Mount Sinai Hospital |
| Lead Investigator: | Ashraf Kharrat |
| Study Sponsor: | |
| Study Contact Information: | Ashraf Kharrat |
| Multi-site Study: | Yes |
| Lay Summary | COVID-19 is a new disease caused by a coronavirus strain called SARS-CoV-2. Women can acquire COVID-19 during pregnancy. There is some evidence that women with COVID-19 has pass the virus to the infant through the placenta, and their pregnancy as well as the baby may be effect by the virus. At this point, we know very little about the complications and these babies may face. The objective of our study is to follow up all infants born to women who are COVID-19 positive, to assess their outcomes and to identify any health or developmental complications.
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| Clinicaltrials.gov link |
Coagulopathy of COVID-19: A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation versus Standard Care as a Rapid Response to the COVID-19 Pandemic (RAPID COVID COAG)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | St. Michael’s Hospital, Li Ka Shing Knowledge Institute, University of Toronto |
| Lead Investigator: | Michelle Sholzberg |
| Study Sponsor: | St. Michael’s Hospital, Li Ka Shing Knowledge Institute, University of Toronto |
| Study Contact Information: | Bruna Camilotti |
| Multi-site Study: | Yes |
| Lay Summary | Coagulopathy of COVID-19 is a bleeding disorder that afflicts approximately 20% of patients with severe COVID-19 and is associated with need for critical care and death. COVID-19 coagulopathy seems to be characterized by an elevated D-dimer, a blood test result that is elevated upon activation of the coagulation system; and a mildly prolonged prothrombin time, another blood test in which results suggest consumption of coagulation factors – essential for proper formation of blood clots. To date, it seems that COVID-19 coagulopathy manifests with excessive clotting, thus blood thinners may be of benefit. Heparin is a blood thinner widely used to prevent and treat blood clots in hospitalized patients. The standard of care for hospitalized patients with COVID-19 coagulopathy is a small dose of this blood thinner to prevent blood clots. It is possible that giving patients a higher dose of heparin might decrease the risk of blood clots and other serious complications related to COVID-19. This study is being done as higher dose heparin seems like a promising treatment, but it is not yet clear if it is more effective at decreasing the complications of COVID-19. This is a randomized controlled trial that will determine the effect of higher dose heparin – low molecular weight heparin (LMWH) or unfractionated heparin (UFH) – compared to standard care in hospitalized patients with COVID-19 coagulopathy. |
| Clinicaltrials.gov link |
COVID-19: Impact on Adults with Mental Health Problems (CovidIAMH)
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | No |
| Study Type: | Observational |
| Lead Site: | Centre for Addiction and Mental Health |
| Lead Investigator: | Benoit Mulsant |
| Study Sponsor: | |
| Study Contact Information: | Athina Perivolaris |
| Multi-site Study: | Yes |
| Lay Summary | The purpose of this study is to assess the impact of the current COVID-19 pandemic on the mental health and well-being of adults with or without pre-existing mental health problems. This information will be collected by phone or videoconference using a series of standard quantitative scales to assess the participants mental health (e.g., mood, anxiety, stress level, cognition) and well-being (e.g., quality of life, function); a subgroup will also be invited to participate in a semi-structured qualitative interview that will be audio recorded that will be systematically coded and analyzed. Results of this research will document the experience of adults with mental health problems during this pandemic and may be used to develop interventions for similar scenarios. |
| Clinicaltrials.gov link |
Healthcare Worker Seroprevalence of anti-SARS-CoV-19 Antibodies
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | The Hospital for Sick Children |
| Lead Investigator: | Michelle Science |
| Study Sponsor: | The Hospital for Sick Children |
| Study Contact Information: | Michelle Science |
| Multi-site Study: | Yes |
| Lay Summary | Baseline blood will be obtained on 300 frontline healthcare workers (HCW) and tested for SARS-CoV-2 antibodies. A validated serologic commercial assay that detects immunoglobulin G and A of SARS-CoV-2 will be utilized. HCWs will be followed and monitored for symptoms over a 3 month period. If a HCW develops symptoms, they will be tested using nasopharyngeal aspirate, and sera will be collected at day 7, 14 and 28 to evaluate IgG response. Follow-up blood will be taken from all enrolled healthcare workers after 3 months and similarly tested for SARS-CoV-2. Results may be a useful tool to guide healthcare worker management and inform targeted testing strategies.
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| Clinicaltrials.gov link |
ANTITHROMBOTIC THERAPY TO AMELIORATE COMPLICATIONS OF COVID-19 (ATTACC)
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | UHN – Toronto General Hospital |
| Lead Investigator: | Ewan Goligher |
| Study Sponsor: | University of Manitoba |
| Study Contact Information: | Nishita Parekh |
| Multi-site Study: | Yes |
| Lay Summary | The aim of the study is to establish if heparin improves outcomes (reduces intubation or death) by 30 days. The study will be ongoing during the COVID-19 pandemic and will follow participant outcomes up to a maximum of 90 days.
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| Clinicaltrials.gov link |
COVID-19 Virtual Care at Home
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | London Health Sciences Centre |
| Lead Investigator: | Anthony Tang |
| Study Sponsor: | London Health Sciences Centre |
| Study Contact Information: | Sabrina Wall |
| Multi-site Study: | Yes |
| Lay Summary | The overall objective is to assess and implement a strategy to bring quality care to COVID-19 positive patients who are isolated at home. A virtual care model using the VIRTUES (Virtual Integrated Reliable Transformative User-Driven E-health System) platform for the management of COVID-19 patients at home will be implemented, by integrating monitoring of vital signs, O2 saturation, and connecting patients with a COVID-19 care team. This study is a prospective non-randomized cohort study of 2,000 COVID-19 positive patients from 10 centres in Ontario. The patient population will include any COVID-19 positive patient that is to be managed at home, including those not admitted to hospital after initial diagnosis and those discharged after their hospital admission, which may facilitate early discharge from the hospital. Patients must have access to the internet and have a computer, smart phone or tablet. Patients will be given access to the VIRTUES platform, so that they can provide symptoms and vital sign to the clinicians. |
| Clinicaltrials.gov link |
Use of High Dose Inhaled Nitric Oxide in Patients Admitted with COVID-19 (High Dose iNO for COVID-19)
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | University Health Network |
| Lead Investigator: | Marcelo Cypel |
| Study Sponsor: | University Health Network |
| Study Contact Information: | Jennifer Lister |
| Multi-site Study: | Yes |
| Lay Summary | Novel therapies are desperately needed for treatment of COVID-19 patients. At present, there are no proven interventions to prevent progression of the disease or to rapidly treat patients with COVID-19 related respiratory failure. Nitric oxide is an important signaling molecule between cells and is involved in a wide range of processes. The most common clinical indications for iNO are for patients with pulmonary hypertension and for selected patients with hypoxemia, due to iNO’s marked vasodilatory effects on the pulmonary vascular bed. In this study, patients with COVID-19 will be randomized to receive either standard of care or high dose nitric oxide (3 times per day for 5 days). We look to determine whether high dose inhaled NO therapy prevents progression to ARDS in patients with mild to moderate COVID-19 admitted to hospital and AND whether high dose inhaled nitric oxide (iNO) can reverse virus burden and respiratory failure in patients on mechanical ventilation. |
| Clinicaltrials.gov link |
Interferon Lambda for Immediate Antiviral therapy at Diagnosis (ILIAD): A phase II randomized, open-label, multicenter, trial to evaluate the effect of peginterferon lambda for the treatment of COVID-19
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | University Health Network |
| Lead Investigator: | Jordan Feld |
| Study Sponsor: | University Health Network |
| Study Contact Information: | Jordan Feld |
| Multi-site Study: | Yes |
| Lay Summary | Covid-19 is a novel coronavirus that has led to a global pandemic due to its relatively high transmissibility and potential to cause severe acute respiratory disease. There are currently no approved therapies for coronavirus disease-19 (COVID-19) and although various antiviral strategies are under evaluation, none has shown significant benefits in early phase trials.
Based on extensive human safety data using the study drug (PegIFN-) and strong mouse data supporting the use of IFN- in acute respiratory infection, this study will evaluate PegIFN- in patients with mild to moderate COVID-19. This study will treat two different populations of patient – hospitalized and non-hospitalized patients. Non-hospitalized patients will receive a single injection of the study drug on day 1 and be sent home to self-quarantine for 14 days as per Provincial Health guidelines. During this time, they will be monitored regularly by the study team and assessed for symptoms of Covid-19 as well as any potential side effects from the study drug. Blood work and nasal swabs will also be collected during this time and picked up by a study team member at regular intervals. If agreeable, we will also ask other members of the the household if they experience symptoms of Covid-19. Hospitalized patients will receive 2 doses of the study drug – one on day 1 and a second dose on day 8. During their hospital stay, they will be monitored by the study team daily for symptoms of Covid-19 as well as any potential side effects of the study medication. Blood work, nasal swabs, and rectal swabs will be collected to assess for safety as well as the effectiveness of the study treatment.
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| Clinicaltrials.gov link |
Automated Oxygen Titration, Monitoring and Weaning in patients with infectious pneumonia requiring oxygen impact on the number of interventions for healthcare workers. An innovative device to manage patients with COVID-19 pneumonia COVID study (Closed-Loop Oxygen to Verify that healthcare workers Interventions Decrease during pneumonia)
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | Hamilton Health Sciences |
| Lead Investigator: | Alison Fox-Robichaud |
| Study Sponsor: | Laval University |
| Study Contact Information: | Alison Fox Robichaud |
| Multi-site Study: | Yes |
| Lay Summary | This study is uses an automated oxygen monitoring device to increase or decrease the amount of oxygen in patients with infectious pneumonia including COVID-19 requiring oxygen. TheFreeO2 device adjusts the oxygen levels with a hypothesis that compared to the manual oxygen administration, this device will reduce the number of bedside interventions by healthcare workers and reduces the risk of nosocomial transmission of infection. It may also decrease the oxygen resources in a hospital by providing the correct amount based on measurements.
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| Clinicaltrials.gov link |
Analysis of Ocular Fluid Specimens in Patients with COVID-19
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | St. Michael’s Hospital |
| Lead Investigator: | Rajeev Muni |
| Study Sponsor: | |
| Study Contact Information: | Contact |
| Multi-site Study: | Yes |
| Lay Summary | The purpose of this research study is to determine the incidence rate of viral shedding in ocular fluids of patients with SARS-CoV-2 infection. We are hoping to collect anterior chamber and vitreous samples from patients with confirmed current or past COVID-19 infection of any duration in order to study the transmissibility of the virus and analyze the role of inflammatory biomarkers in the disease process. These findings will be essential in enabling the development of targeted strategies to help combat the spread of COVID-19.
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| Clinicaltrials.gov link |
Impact of COVID-19 on Surgical Care in Ontario- Identification of Gaps in Essential Procedures and Strategies to Enhance Surgical Care Delivery (Mitigating the impact of COVID-19 on Surgical Care Delivery)
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | University Health Network |
| Lead Investigator: | Michael Fehlings |
| Study Sponsor: | |
| Study Contact Information: | Ali Moghaddamjou |
| Multi-site Study: | Yes |
| Lay Summary |
Due to the COVID-19 pandemic many surgical procedures across the province have been delayed or cancelled. These delays are having a significant impact on our health care system and to those patients whom surgeries have been cancelled. We did not expect cancellations at this scale and hence we do not have any strategies to address this problem. We can expect a bottle-neck to resuming surgical care delivery. The goal of this study is to first report on the number of procedures that are delayed and then to use this information to come up with guidelines to assist surgeons and administrators in allocating resources appropriately.
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Lessening Organ Dysfunction with VITamin C-COVID (LOVIT-COVID)
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | Sunnybrook Health Sciences Centre |
| Lead Investigator: | Neil Adhikari |
| Study Sponsor: | University de Sherbrooke |
| Study Contact Information: | contact |
| Multi-site Study: | Yes |
| Lay Summary | This study aims to determine whether the administration of vitamin C in patients with confirmed COVID, admitted to the hospital improves their health status. The treatments for this infection are limited to antivirals and supportive care for bodily functions (like hydration fluids in the veins, mechanical ventilation and treatment to ensure kidney function). Recent studies suggest that high doses of vitamin C given into veins may be the first therapy helping the body to fight infections. The goal of this study is to determine if the administration of vitamin C decreases the harmful effects of the infection on organs and improves your health status more rapidly than placebo. The specific objectives are to evaluate the effects of vitamin C on patients’ health status and quality of life at 6 months and on blood levels of biomarkers that reflect cellular health.
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| Clinicaltrials.gov link |
Lessening Organ Dysfunction with VITamin C (LOVIT)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | McMaster University |
| Lead Investigator: | Sheila Sprague |
| Study Sponsor: | University de Sherbrooke |
| Study Contact Information: | contact |
| Multi-site Study: | Yes |
| Lay Summary | This study aims to determine whether the administration of vitamin C in patients admitted to an intensive care unit (ICU) with a serious infection improves their health status. The treatments for infections are limited to antibiotics and supportive care for bodily functions (like hydration fluids in the veins, medication to maintain blood pressure, mechanical ventilation and treatment to ensure kidney function). Recent studies suggest that high doses of vitamin C given into veins may be the first therapy helping the body to fight serious infections. The goal of this study is to determine if the administration of vitamin C decreases the harmful effects of the infection on organs and improves your health status more rapidly than placebo. The specific objectives are to evaluate the effects of vitamin C on patients’ health status and quality of life at 6 months and on blood levels of biomarkers that reflect cellular health.
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| Clinicaltrials.gov link | NCT03680274
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COVID-19: Risks to Mental Health in Seniors (CRiMHS)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | Rotman Research Institute, Baycrest Health Sciences |
| Lead Investigator: | Linda Mah |
| Study Sponsor: | |
| Study Contact Information: | contact |
| Multi-site Study: | Yes |
| Lay Summary | Public health measures including isolation of cases, physical distancing and voluntary home quarantine are currently the only means to mitigate the impact of the 2019 novel coronavirus (COVID-19) pandemic. Moreover, these personally and socially-disruptive measures may need to be enforced for months. Older adults age 60+ years, who are at increased risk for greater severity of illness, hospitalization and death with COVID-19 infection, have been advised to self-isolate and receive visitors or leave home only for essential reasons. Yet the psychological effects of prolonged self-isolation and physical distancing are unknown. This is particularly relevant for seniors, for whom social isolation is linked to greater medical and psychiatric comorbidity as well as death. This study will examine changes in mental health and the psychological impact of community-based public health measures during the COVID-19 outbreak in Toronto in 475 older adults who are being followed longitudinally across two studies. The knowledge gained from this study will allow public health officials to make informed decisions on how to achieve the epidemiological benefits of socially-disruptive community measures, without compromising mental health in seniors. As well, the outcomes of this study will inform the development of resources and interventions to support seniors during this time. |
| Clinicaltrials.gov link |
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Seroprevalence of COVID-19 among African Canadians: Clinical and Epidemiological Correlates (seroMARK Study)
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | The Hospital for Sick Children
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| Lead Investigator: | Upton Allen |
| Study Sponsor: | The Hospital for Sick Children
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| Study Contact Information: | contact
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| Multi-site Study: | Yes |
| Lay Summary | Given the reports that African American and their UK counterparts are at increased risk of bad outcomes from COVID-19, it is important to get a better idea of the prevalence of COVID-19 infection among African Canadians and the factors that are associated with this infection. We plan to test a large number of persons of African ancestry in Ontario to determine if they have evidence of COVID-19 infection as indicated by antibody responses. Individuals with antibody response to COVID-19 are more likely than not, to have at least partial immunity to future infections with the virus that causes COVID-19. This information will not only give us a better idea of the extent to which COVID-19 has affected the community, but also the extent to which the community might be protected should there be a second wave of the infection during the Fall of 2020. This is based on the hope that individuals who have recovered from COVID-19 are more likely to get milder infection if they were to get re-infected in the future. Our research will determine the risk factors that are associated with infection and disease. These potential risk factors include chronic medical conditions as well as socioeconomic factors. |
| Clinicaltrials.gov link |
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Impact of COVID-19 pandemic on time to retinal detachment repair – a multicenter retrospective comparative interrupted time-series (COVID RD-REPAIR)
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | St. Joseph’s Healthcare Hamilton – Hamilton Regional Eye Institute
|
| Lead Investigator: | Varun Chaudhary |
| Study Sponsor: | |
| Study Contact Information: | contact
|
| Multi-site Study: | Yes |
| Lay Summary | Retinal detachment (RD) is a serious and urgent eye condition that involves the detachment of the retina from the back of the eye resulting in vision loss potentially leading to blindness. Retinal detachments can progress from partial to full detachments in a very short period (ranging from months to even hours) and many cases require immediate surgical treatment. Based on these factors, timely management of the disease is of the utmost importance as delays between symptom onset and assessment by a retinal specialist could result in significant visual loss. Previous studies have shown that a lack of awareness of RD symptoms on the part of the patient have resulted in delays to treatment. The COVID-19 crisis has only complicated this issue both on the side of the physician (limited clinic volume) and of the patient (delaying follow-up due to fear of viral transmission). In light of significant changes to provision of care and patient follow-up imposed by the COVID-19 crisis, we hope to determine whether pathways to timely treatment and follow-up for retinal detachment have been adversely affected. We propose a multicenter, retrospective comparative interrupted time-series to determine whether the COVID-19 crisis has impacted time to treatment, surgical management, and functional outcomes for patients with RRD.
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| Clinicaltrials.gov link |
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A prospective randomized trial of prone positioning versus usual care for patients with do-not-intubate goals of care and hypoxemic respiratory failure during the coronavirus SARS-CoV-2 (COVID-19) pandemic. (CORONA)
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | Research Institute of St. Josephs; Healthcare Hamilton
|
| Lead Investigator: | Waleed Albazzani |
| Study Sponsor: | University of Calgary |
| Study Contact Information: | |
| Multi-site Study: | Yes |
| Lay Summary | The CORONA study looks to determine if lying on your stomach for at least 8 hours per day improves outcomes for people with COVID-19 who require supplemental oxygen but are not candidates for invasive mechanical ventilation in the ICU. We hypothesize that prone positioning (lying on your stomach) will reduce in-hospital mortality or discharge to hospice, compared with usual care for non-intubated patients with do-not-intubate goals of care with hypoxemic respiratory failure due to probable COVID-19. |
| Clinicaltrials.gov link |
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The GEMINI Hospital Cohort Study
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | St. Michael’s Hospital
|
| Lead Investigator: | Fahad Razak |
| Study Sponsor: | |
| Study Contact Information: | Chloe Chow |
| Multi-site Study: | Yes |
| Lay Summary | Delirium is an acute neurocognitive disorder which affects up to half of older hospitalized medical patients. It can cause confusion, disorientation, hallucinations, and agitation, leading to significant distress for patients and their caregivers. It can lead to dementia, longer hospital stays, increased health costs, and death. Delirium can be prevented and treated, but it is difficult to identify and predict. We have utilized artificial intelligence (AI) to develop two automated tools, which use routine data extracted from electronic medical records to identify delirium cases and predict patient delirium risk. As there is concern that AI applications may worsen health inequity because they do not take social and economic variables into consideration, we will test whether there is bias in delirium detection and prediction with our tools. In addition, this study aims to validate these AI-based delirium tools; compare the performance of AI tools during the COVID-19 pandemic to historical pre-pandemic tools; and to assess the feasibility of socioeconomic and demographic data collection in an inpatient setting.
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| Clinicaltrials.gov link |
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A Multicentric Collaboration to Evaluate Quantitative Serological Assays for SARS-CoV-2 (CONQUER)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | Kingston Health Science Centre |
| Lead Investigator: | Yanping Gong |
| Study Sponsor: | Kingston Health Science Centre |
| Study Contact Information: | Sabourin
|
| Multi-site Study: | Yes |
| Lay Summary | With the advancement in the diagnosis and treatment of COVID-19 infection, various instruments and methods become available in the clinical laboratories. First, it is important to standardize the methods among laboratories which will ensure comparable results will be produced regardless of the testing sites. Second, it is important to characterize the antibody tests so that we understand the testing characteristic at different stages of the infection. For example, how early COVID-19 antibodies appear and how long they last in a patient’s blood specimens are important information to help us manage those patients. Third, after a vaccine for COVID-19 is available, reliable, standardized and well-characterized serology tests are critical to evaluate the effectiveness/protective immunity after vaccination.
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| Clinicaltrials.gov link |
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InterferOn lambDa therapY for Symptomatic SARS-CoV-2 EarlY in infection (ODYSSEY): A phase III randomized, double-blind, placebo-controlled, multicenter, trial to evaluate the effect of peginterferon lambda for the treatment of COVID-19 (ODYSSEY)
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | University Health Network
|
| Lead Investigator: | Jordan Feld |
| Study Sponsor: | University Health Network |
| Study Contact Information: | |
| Multi-site Study: | Yes |
| Lay Summary | There is no approved specific therapy for COVD-19 for people who do not need to be in hospital. The standard or usual treatment for COVID-19 is self-isolation for mild cases. In response to a viral infection, your body naturally produces hormones called interferons. There are different types of interferon known as alpha, beta, and lambda that all help fight off viral infections. Man-made interferons have been developed to treat viral infections and have been used successfully for over 20 years. Peginterferon is a form of any type of interferon with a long-lasting effect, fighting the virus for up to 7 days. In a small study of people with mild to moderate COVID-19 (total 60 people), a single injection of peginterferon lambda sped up the time to clear the virus that causes COVID-19. The side effects of a single injection of peginterferon lambda were similar to the side effects in people who received a placebo injection (salt water). More people who received peginterferon lambda than placebo had a rise in their liver blood tests following the treatment. The blood tests returned to normal levels by the end of the study (2 weeks). Similar results were seen in another study of peginterferon lambda for mild COVID-19 (total 120 people). Peginterferon lambda has also been given to over 3,000 people with hepatitis virus infections (infections of the liver). Peginterferon lambda was effective at suppressing or curing hepatitis virus infections with fewer side effects than peginterferon alpha (a medication previously used to treat hepatitis B and C infections). |
| Clinicaltrials.gov link |
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Understanding the Process of Critical Care Trial Implementation in a Pandemic Situation (ICU Pandemic Trials)
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | North York General Hospital
|
| Lead Investigator: | Katie Dainty |
| Study Sponsor: | |
| Study Contact Information: | Sara Carbone |
| Multi-site Study: | Yes |
| Lay Summary | Several research trials are currently underway in Ontario intensive care units to test new medications, therapies or treatments to improve outcomes related to the COVID-19 virus. In normal conditions, these types of research trials take a long time to complete; however, the current pandemic situation has added pressure to complete these trials in an efficient manner so that the findings can begin to help improve patient outcomes. In this study, we will explore how the pandemic situation has impacted trial implementation in 5 intensive care unit sites across Ontario. Our goal is to produce guidance on how to successfully implement trials during pandemic situations, in order to allow for more efficient, timely and safe conduct of the research.
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| Clinicaltrials.gov link |
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Preoperative and postoperative cognitive trajectories in older patients with deferred surgery due to the COVID-19 emergency: a prospective cohort study. (Co-TELE-SURGE)
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | McMaster University
|
| Lead Investigator: | Maura Marucci |
| Study Sponsor: | |
| Study Contact Information: | khalem3@mcmaster.ca |
| Multi-site Study: | Yes |
| Lay Summary | Cognition is the way we use our brains to think, understand, remember and make decisions. Cognitive changes are often seen even up to 1 year after surgery. Whether these changes are more than what is expected for someone’s age and morbidities is still uncertain. Due to the COVID-19 emergency, many elective surgeries have been delayed, which is stressful for our patients, but also represents an opportunity of understanding better how surgery can impact our cognitive abilities. The purpose of this study is to explore if and how cognitive performance changes over time for patients aged 65 years or older, whose surgery has been postponed due to the COVID-19 emergency, following and assessing the cognitive performance of these patients over time before and after surgery. In particular, in this study, the participant’s cognitive performance will be assessed periodically with a computer-based instrument for cognitive testing, self-administered at home, in which tests are based on playing cards. |
| Clinicaltrials.gov link |
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The RAPID COVID study – Application of Point-of-Care COVID-19 Testing to Optimize Patient Care, Resource Allocation and Safety for Frontline Staff (The RAPID COVID-19 Point of Care)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | No |
| Study Type: | Clinical Trial |
| Lead Site: | University of Ottawa Heart Institute
|
| Lead Investigator: | Derek So |
| Study Sponsor: | University of Ottawa Heart Institute |
| Study Contact Information: | hcosgrove@ottawaheart.ca |
| Multi-site Study: | Yes |
| Lay Summary | Using a new technology, the RAPID COVID TRIAGE study will conduct the virus genetic testing for COVID-19 at the bedside with a nasal-pharyngeal and nostril swab, with results in under 45 minutes. This new “point-of-care (POC)” technology, if proven accurate, may help future patients receive faster and more definitive treatment. At the same time, it might help health care teams preserve resources and optimize care for patients. the data collected will be used to develop a treatment algorithm that maximizes the potential of POC testing to improve patient outcomes. In addition, we will perform POC testing on Health Care Workers who are awaiting COVID-19 swab results for return to work. Our aim is to show that Health Care Workers can safely return to work sooner if they have POC testing, versus waiting on a core lab result. |
| Clinicaltrials.gov link |
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COVID-19: comprehensive biomarker analysis for prediction of clinical course and patient treatment outcomes (COVID-BEACONS)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | McMaster University
|
| Lead Investigator: | Peter Gross |
| Study Sponsor: | |
| Study Contact Information: | peter.gross@taari.ca |
| Multi-site Study: | Yes |
| Lay Summary | COVID-19 infection is linked to coagulopathy, which likely explains the severity of acute lung injury seen in these patients, as well as the increased incidence of pulmonary embolism, myocardial infarction, and ischemic stroke. This study aims to use blood from patients at various stages of disease to characterize the biochemical defects in the coagulation and fibrinolysis systems to explain why COVID-19 infection causes coagulopathy. By understanding which coagulation systems are damaged, we may be able to identify new pathways to prevent the development of critical illness in COVID-19 infection.
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| Clinicaltrials.gov link |
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Semaglutide to reduce Myocardial injury in PATIents with COVID-19 (SEMPATICO)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | University Health Network Toronto General Hospital |
| Lead Investigator: | Vladimir Dzavik |
| Study Sponsor: | University Health Network, Toronto General Hospital
|
| Study Contact Information: | |
| Multi-site Study: | Yes |
| Lay Summary | The current COVID-19 pandemic is rapidly spreading with a global total of ~35 million cases, with close to 170,000 cases and over 9,500 deaths in Canada alone (as of 10/05/2020). Most affected patients have mild or even no symptoms, however, those requiring hospitalization have a more severe presentation including pneumonia, acute respiratory distress syndrome (ARDS), cardiovascular collapse and death. Current interventions are either supportive in nature or experimental anti-viral ( medications used to treat viruses), anti-inflammatory (medications used to reduce inflammation or swelling), or anti-coagulant( medications used to thin the blood and to prolong clotting time) in nature. Only dexamethasone (medication used to prevent a release of substances that cause infection) has recently been shown to reduce mortality (death). To our knowledge, there is no proposed treatment directly addressing the mechanisms of increased cardiovascular risk in this deadly disease. The purpose of the study is to determine if once weekly treatment of semaglutide medication (GLP-1 agonist) for 4 doses subcutaneously will reduce cardiac as well as non-cardiac complications of COVID 19 infection. Eligible and consented patients with a positive result of COVID 19 infection will be randomized to one of the following two treatment regimens in a 1:1 ratio: (1) semaglutide (medication) 0.25 mg subcutaneous( beneath the skin) immediately after randomization at baseline, then 0.5mg at day 7, day 14, and day 21. The end of treatment period and final assessments will occur on day 28. Final secondary clinical outcome assessment will be at 180 days. The other treatment group will be the control group and will not receive study medication semaglutide. |
| Clinicaltrials.gov link |
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Antibody serum panel from humans to evaluate rapid diagnostic equipment specialized in detecting SARS-CoV-2 (APHERESIS)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | Sunnybrook Health Sciences Centre |
| Lead Investigator: | Jeannie Callum |
| Study Sponsor: | National Microbiology Laboratory
|
| Study Contact Information: | dimpy.modi@sunnybrook.ca |
| Multi-site Study: | Yes |
| Lay Summary | Coronavirus disease (COVID-19) caused by SARS-CoV-2 has rapidly evolved into a global pandemic. To date, front line diagnostic testing to identify acutely infected patients has relied upon molecular based testing platforms (i.e., PCR). In order to better define community transmission and rates of population exposure to SARS-CoV-2 in Canada, assays that can detect antibodies to this virus are urgently needed. A number of different serological platforms (i.e., virus neutralisation, ELISA and rapid test cassettes) are available to detect SARS-CoV-2 antibodies; however, most of the commercial assays have not been fully validated for use. The performance of serological assays is typically based upon how accurately they can identify patients that were (true positives) and were not (true negatives) exposed to a given pathogen. Securing samples from these two broad cohorts is essential to develop the “gold standard” set of serum samples for the validation evaluations. The plasma supplied for this study will also be utilized to perform the donor and recipient testing for the CONCOR-1 trial and to develop a COVID-19 risk score used to identify patients in highest need for treatment and early determination of likely patient outcomes.
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| Clinicaltrials.gov link |
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Co-designing and Pilot Testing an Infographic to Support Patients/Families through the REMAP-CAP Consent Process (REMAP-CAP Consent Infographic)
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | St. Michael’s Hospital |
| Lead Investigator: | John Marshall |
| Study Sponsor: | |
| Study Contact Information: | Zarah.bhimani@unityhealth.to |
| Multi-site Study: | Yes |
| Lay Summary | Background: When choosing to participate in research, it is essential that individuals are well-informed in their decision. Being informed means understanding a study’s purpose, treatments, procedures, risks and benefits. It can be challenging to understand these detailed aspects of a study when they are communicated by researchers and care providers using long, scientific consent documents. It can be even more challenging when research studies are complex, or when research is conducted in vulnerable situations, with vulnerable individuals or within tight time constraints. This is particularly relevant for research involving critically ill patients during a pandemic.
The Problem: The Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community Acquired Pneumonia (REMAP-CAP) is a complex platform trial which studies potential treatments for patients with COVID-19 admitted to the Intensive Care Unit (ICU). A platform trial studies multiple different treatment options and is dynamic, meaning that treatments change over the course of the study. The complex nature of REMAP-CAP and its consent documents, in addition to the stress and anxiety of coping with a critical illness, may create challenges in the communication and understanding of study details for patients and families invited to participate. Patient/Family Partners (PFP) identified a need to improve communication between researchers, care providers and patients/families during the REMAP-CAP consent process. Our Study: This pilot study is a patient-centred co-design project to refine and test an infographic, developed by patients/families and researchers with lived ICU research experience. The infographic will supplement current REMAP-CAP consent documents. Co-design allows the involvement of individuals with lived experience and different perspectives in the process of addressing a health service issue. The use of a co-designed infographic may improve communication during the consent process, increasing patient/family knowledge about REMAP-CAP, increasing the likelihood that patients/families will be satisfied with their decision when considering participation in REMAP-CAP.
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| Clinicaltrials.gov link |
A Phase 2/3, Two-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | Children’s Hospital of Eastern Ontario |
| Lead Investigator: | Charles Hui |
| Study Sponsor: | ModernaTX, Inc. |
| Study Contact Information: | jbowes@cheo.on.ca |
| Multi-site Study: | Yes |
| Lay Summary | The Sponsor (Moderna Tx) has developed a rapid-response proprietary vaccine platform based on a messenger RNA (mRNA) delivery system. Messenger RNA vaccines have been used to induce immune responses against infectious pathogens. The mRNA-based SARS-CoV-2 vaccine developed by Sponsor, called mRNA-1273, has been grated emergency approval for adults. The goal of this study is to support an indication for use of the study vaccine mRNA-1273 in children. The objective for this Phase 2/3 study is to evaluate the safety, tolerability, reactogenicity, and effectiveness of up to 3 dose levels of mRNA-1273 vaccine administered as 2 doses 28 days to healthy children 6 months to < 12 years of age divided into 3 age groups (6 to < 12 years, 2 to < 6 years, and 6 months to < 2 years). The study will enroll children from Canada and the United States. Each participant will receive 2 doses of IP by IM injection approximately 28 days apart. This study in children 6 months to < 12 years of age will monitor all participants for a total of 12 months following the second dose of vaccine or placebo. In order to demonstrate vaccine effectiveness, the study will measure antibody responses in the study participants.
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| Clinicaltrials.gov link | NCT04796896
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COVID-19 Vaccine-induced Inflammatory Heart Disease Prevalence Registry (COVID-VIHPR)
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | University of Ottawa Heart Institute |
| Lead Investigator: | Peter Liu |
| Study Sponsor: | |
| Study Contact Information: | emoga@ottawaheart.ca |
| Multi-site Study: | Yes |
| Lay Summary | Myocarditis and pericarditis are inflammatory diseases of the heart muscle (myocardium) and the membrane that covers the heart (pericardium), and can be related to different causes, including vaccines. In the past, some people have developed inflammatory heart disease after receiving a live or inactive virus vaccine (smallpox vaccine or flu vaccine). Myocarditis was also seen in patients with COVID-19. More recently, many countries reported that some patients have developed an inflammatory condition of the heart muscle or the membrane around the heart, after receiving an mRNA (messenger RNA) vaccine for COVID-19. (Pfizer BioNTech, Moderna).
In the past months, doctors have noticed more patients presented to the Emergency Department with chest pain and shortness of breath after receiving an mRNA vaccine, symptoms that are resembling myocarditis or pericarditis. These symptoms may start between 2 to 10 days following mRNA vaccination and are frequently noticed after the second dose of the mRNA vaccines. While pericarditis seems to affect people of various age groups and gender, myocarditis is more commonly seen in young male patients. Most cases of myocarditis and pericarditis post COVID-19 vaccine were mild and temporary. Significant complications, including death, were very rare (1%-2%) and were only observed in people with multiple associated conditions. However, the myocarditis and pericarditis that develop after mRNA vaccines may not be reported in all the patients that have symptoms after receiving the vaccine. The study aims to establish a registry database of patients who develop vaccine-induced inflammatory heart disease after a COVID-19 vaccination. |
| Clinicaltrials.gov link |
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COVID-19 Vaccine Immunogenicity and Safety in Immunodeficient Patients – VISID study
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | No |
| Study Type: | Observational |
| Lead Site: | Ottawa Hospital Research Institute |
| Lead Investigator: | Juthaporn Cowan |
| Study Sponsor: | |
| Study Contact Information: | byazji@ohri.ca |
| Multi-site Study: | Yes |
| Lay Summary | The vaccine efficacy data from reported clinical trials are not applicable to immunocompromised patients as this patient population was excluded. We propose a prospective observational study to measure vaccine response and safety in non-HIV, non-transplant immunocompromised patients. |
| Clinicaltrials.gov link |
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Experiences and opinions of bereaved family caregivers and healthcare providers regarding the impact of COVID-19 on cancer care at the end of life: A Qualitative Study (CIHR COVID Qual Project)
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | Princess Margaret Cancer Centre |
| Lead Investigator: | Camilla Zimmerman |
| Study Sponsor: | |
| Study Contact Information: | nadia.swami@uhnresearch.ca |
| Multi-site Study: | Yes |
| Lay Summary | The COVID-19 pandemic has had a large impact on cancer care, resulting in restrictions to hospital and community services as well as to inpatient visitors. In particular, patients with low socioeconomic position (SEP) with cancer have been identified as a population that is less likely to access high-quality cancer care and end-of-life care during the pandemic due to economic and geographical barriers. Therefore, COVID-19 may have disproportionately affected palliative care for patients of low SEP, but there has been no known research on this in Ontario. Our aim is to understand the impact of the COVID-19 pandemic on the use of palliative care services at the end of life for patients with cancer, and examine possible differences in patients of low SEP. We will use individual and group interviews to understand the perspectives and experiences of bereaved family caregivers and healthcare workers regarding access to palliative care at the end of life for patients with cancer who died during the pandemic. Our research team includes experienced researchers, clinicians and policy-makers, in order to ensure that the results of our research are incorporated into practice. This project will help inform strategies to improve the delivery of palliative care for patients with cancer during and beyond the ongoing COVID-19 pandemic.
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| Clinicaltrials.gov link |
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A Multi-Center Evaluation of Buccal Swabs with the Abbott ID NOWTM COVID-19 for Point-of-Care Detection SARS-CoV-2 in Pediatric Emergency Departments (PERC-Health Canada Abbott ID NOW COVID-19 Buccal Swab Evaluation Study)
| Status: | Pending |
| CTO Streamlined Ethics: | Submitted |
| Seeking Additional Sites: | No |
| Study Type: | Clinical Trial |
| Lead Site: | Children’s Hospital of Eastern Ontario |
| Lead Investigator: | Roger Zemek |
| Study Sponsor: | Departments of Pediatrics and Emergency Medicine University of Calgary |
| Study Contact Information: | tcrawford@cheo.on.ca |
| Multi-site Study: | Yes |
| Lay Summary | The purpose of this research study is to determine if a swab from the inside of the cheek can detect COVID-19 with the same level of accuracy as standard nose and throat swabs in children. The study will use The Abbott ID NOWTM COVID-19 device to test the cheek swab. The Abbott ID NOWTM COVID-19 device is approved by Health Canada for rapid COVID testing but only for nose and throat swabs which can be unpleasant. This study will help us figure out if a swab from the inside of the cheek using the Abbott ID NOWTM device is a valid way to detect COVID in children. We would also like to understand feelings you or your child have about performing the cheek swab in comparison to standard nose and throat testing.
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| Clinicaltrials.gov link |
Pregnant and Lactating Individuals & Newborns COVID-19 Vaccination (PLAN-V) Prospective Cohort Study
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | Ottawa Hospital Research Institute |
| Lead Investigator: | Darine El-Chaar |
| Study Sponsor: | |
| Study Contact Information: | sramlawi@ohri.ca |
| Multi-site Study: | Yes |
| Lay Summary | With the current roll-out of COVID-19 vaccines, there is an urgent need to assess the safety of the COVID-19 vaccines in pregnant individuals, to assess the immune response they generate, and to assess the extent of protection they provide to mothers and their newborns. The PLAN-V Study will build on the successes of the COVID-19 Ontario Pregnancy Event (COPE) Network – a collaboration of 13 obstetrical hospitals in 6 of Ontario’s’ largest cities – to launch an in-depth study of pregnant individuals and their newborns.
We will recruit vaccinated participants for close clinical follow-up, detailed data collection and biological sample analysis in pregnancy, at delivery and across the postpartum period. We will evaluate maternal immune responses to vaccination and examine evidence for transfer of protective antibodies to the newborn. This work will address key questions about COVID-19 vaccines during pregnancy that are important to Canadian families and their care providers. The PLAN-V Study is designed to fill critical knowledge gaps, and in doing so, will help inform public health recommendations, guide vaccine awareness efforts for pregnant individuals, and support patient counselling and informed decision-making by Canadians.
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| Clinicaltrials.gov link |
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The impact of COVID-19 on persons with HIV in Canada: Data from the HIV/HCV co-infection/CCC (CTN 222) and HIV aging cohorts (CTN 314). (CHANGE/CCC COVID-19 Substudy)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | University Health Network |
| Lead Investigator: | Sharon Walmsley |
| Study Sponsor: | |
| Study Contact Information: | rosemarie.clarke@uhn.ca |
| Multi-site Study: | Yes |
| Lay Summary | This study aims to use the Aging with HIV (CHANGE HIV; CTN314) and the Canadian Co-infection Cohort (CCC; CTN222), two pre-existing HIV cohorts, to explore the effects of COVID-19 on Persons living with HIV (PLWH) through questionnaires and COVID antibody testing. The questionnaires will address the psychosocial experience of this population during the COVID-19 pandemic and their satisfaction with virtual care.
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| Clinicaltrials.gov link |
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COV-IMMUNO - A RANDOMIZED, PHASE III TRIAL OF IMMUNIZATION WITH IMM-101 VERSUS OBSERVATION FOR THE PREVENTION OF SEVERE RESPIRATORY AND COVID-19 RELATED INFECTIONS IN CANCER PATIENTS AT INCREASED RISK OF EXPOSURE (IC.8)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | The Ottawa Hospital Cancer Centre |
| Lead Investigator: | Rebecca Auer |
| Study Sponsor: | Canadian Cancer Clinical Trials Group |
| Study Contact Information: | lturriff#@toh.ca |
| Multi-site Study: | Yes |
| Lay Summary | This is a multi-centre, open-label, randomized phase III trial comparing immunization with IMM-101 versus observation for the prevention of severe respiratory and COVID-19 related infections in cancer patients at increased risk of exposure. IMM-101 is a new type of immune stimulating therapy being developed for the treatment of cancer that may also help in preventing severe respiratory and COVID-19 infections.
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IMPACT OF RESTRICTED VISITATION POLICIES IN THE COVID-19 PANDEMIC ON PARENTS OF CRITICALLY ILL CHILDREN (COVID-19 VISITATION POLICIES)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | Children’s Hospital of Eastern Ontario |
| Lead Investigator: | Kusum Menon |
| Study Sponsor: | IWK Health Centre |
| Study Contact Information: | kohearn@cheo.on.ca |
| Multi-site Study: | Yes |
| Lay Summary | The SARS-coronavirus-19 (COVID-19) pandemic has resulted in restricted family presence practices and visitation policies in children’s hospitals. One of the key tenets of family centred care in a pediatric hospital is inclusion of the family in all aspects of a child’s care, and particularly the ability to be present with their child throughout a critical illness requiring intensive care.. The operationalization of these policies in the pandemic setting, and impact on the families and children and the staff who must enforce them has not been examined, but must be understood to inform ongoing decisions. This is a survey study to understand the issues experienced as important and/or stressful by families of critically ill children during the period of restricted family presence associated with the COVID-19 pandemic. The survey will be administered electronically, and will be sent to families from participating centres who had a child admitted to the PICU from March 1 to June 30, 2020. The findings of this study will provide important information about how the restrictions are experienced by patients and their families, and may serve to inform the ongoing ethical discourse around parental and family presence with our sickest patients. This will provide policymakers and healthcare professionals with important family-centered information to enable informed decision-making as the pandemic progresses and for future pandemics. Healthcare centres may use the results to inform the design of interventions aimed at mitigating any effects experienced by parents and families.
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LIVING WITH CANCER IN THE TIME OF COVID-19: A COHORT STUDY OF THE IMPACT OF COVID-19 PANDEMIC ON CANCER PATIENTS DURING TREATMENT AND SURVIVORS (SC.27)
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | Sunnybrook Health Science Centre |
| Lead Investigator: | Kelvin Chan |
| Study Sponsor: | Canadian Cancer Clinical Trials Group |
| Study Contact Information: | ivana.prce@sunnybrook.ca |
| Multi-site Study: | Yes |
| Lay Summary | This is a prospective cohort study design that will examine cancer patients’ experiences, psychosocial outcomes, perceptions of care, and coping strategies related to the COVID-19 pandemic. Participants will be followed over 12 months and asked to complete on-line questionnaires at baseline, and again at 2, 4, 6 and 12 months.
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An Analysis of Emergency Department Self-Harm Presentations during the COVID-19 Pandemic
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Observational |
| Lead Site: | Sunnybrook Health Science Centre |
| Lead Investigator: | Mark Sinyor |
| Study Sponsor: | |
| Study Contact Information: | rabia.zaheer@sri.utoronto.ca |
| Multi-site Study: | Yes |
| Lay Summary | This study will investigate how the COVID-19 pandemic affects the rate of trauma and non-trauma Emergency Department (ED) admissions for self-harm (SH). The study will also compare the demographic, clinical, and lifestyle characteristics of SH admissions prior to and following the pandemic. These characteristics include age, sex, pre-existing conditions, and type of injury. Data will be collected through accessing the trauma registry, which logs clinical and demographic data for patients with trauma-level injuries, as well as electronic medical records (EMRs). The study team will use data from three main Toronto trauma hospitals: Sunnybrook Hospital, The Hospital for Sick Children, and St. Michael’s Hospital. To represent the pre-pandemic period, comparative data will be collected from 2011 to 2019. Post-pandemic data will be collected from March 2020 to February 2021.
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Third Dose of Moderna mRNA-1273 COVID-19 Vaccine in Residents of Long-Term Care Facilities
| Status: | Open |
| CTO Streamlined Ethics: | Approved |
| Seeking Additional Sites: | Yes |
| Study Type: | Clinical Trial |
| Lead Site: | McMaster University |
| Lead Investigator: | Mark Loeb |
| Study Sponsor: | McMaster University |
| Study Contact Information: | barthol@mcmaster.ca |
| Multi-site Study: | Yes |
| Lay Summary | This study aims to determine if a third dose of an mRNA vaccine in residents of long-term care facilities will lead to a better immune response than two doses. If a third dose of an mRNA vaccine provides an improved immune response, that would give long term care residents better overall protection against COVID 19. It could also inform policy-makers to make sure that all long-term care residents receive a third COVID vaccine dose. The study will determine this outcome by randomly selecting residents to receive vaccines in two groups: one group will receive a dose of the mRNA-1273 Moderna COVID-19 vaccine and the other will receive a hepatitis A vaccine.
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