RI-MUHC innovative clinical trial assesses hydroxychloroquine for prevention and treatment of COVID-19
Montreal - Determined to fight the spread of the COVID-19 pandemic, researchers at the Research Institute of the McGill University Health Centre (RI-MUHC) have launched an innovative clinical trial for which people can enroll online and participate entirely from home. The study will assess whether the drug Hydroxychloroquine (HCQ) - a Health Canada approved drug that is used to treat malaria and some autoimmune conditions like Lupus - can prevent people from contracting COVID-19 after exposure to the SARS-CoV2 virus and whether it can decrease complications and deaths related to the disease. Coordinated with a large study led by Dr. David Boulware at the University of Minnesota, the clinical trial is taking place not only in Quebec, but also in Manitoba, Alberta and the United States.
With this trial, the researchers hope to show that HCQ can decrease the risk of spread of the virus in people exposed to infected individuals, reduce progression to severe disease requiring hospitalization and ventilator support, and lower the number of deaths from COVID-19. Observational studies have suggested that HCQ might have some action against COVID-19, but evidence is needed to confirm potential treatment options.
“Hydroxychloroquine is an old drug with a good safety record, and we hope that it can help solve the public health crisis that we’re in today,” says principal investigator Dr. Todd C. Lee, Scientist at the RI-MUHC and Associate Professor of Medicine, Division of Infectious Diseases at McGill University. “We are excited that Quebec is leading this study in Canada and to be able to offer the population a promising option for treatment.”
In this two-arm study, HCQ or a placebo will be given to clinical trial participants who have tested positive for COVID-19 or who have a high-risk exposure to individuals who tested positive. The trial started on March 26, 2020 with the enrollment of health care workers who were exposed to patients with a confirmed positive infection, and is now open to all eligible adults in the province of Quebec.
“We are in desperate need of a treatment to prevent the spread of COVID-19 amongst health care professionals,” says Dr. Emily G. McDonald, Investigator at the RI-MUHC and Director of the MUHC Clinical Practice Assessment Unit. “In order for doctors and nurses to continue treating patients, and for their own safety, we need a proven treatment that protects if they are accidentally exposed to the SARS-CoV-2 virus.”
“Preventing the spread of COVID-19 is paramount,” adds Dr. Lee. “We need a treatment that is proven to be effective so that we can decrease the spread of the virus between people who have been exposed.”
Participants are eligible for the treatment arm of the clinical trial if they have a confirmed diagnosis of COVID-19, their symptoms began in the last three to four days and they are self-isolating at home. Other participants are eligible for the prevention arm of the trial if they live with a person with COVID-19, or they have undergone a high-risk exposure to someone with a confirmed case of COVID-19 within the past three to four days and they don’t yet have symptoms.
Eligible adults can enroll through a self-referral process online after answering a series of questions. The participants won’t have medical visits with the researchers because of the contagious nature of the disease. Instead, the drug or placebo will be shipped to them the day after they are determined eligible and are enrolled in the trial. They will then take the drug or the placebo for five days and complete at least one additional online survey.
People who meet these criteria and wish to enroll in the clinical trial should visit covid-19research.ca to access the online screening questionnaire to determine their eligibility.
This clinical study is made possible through funding from the MUHC Clinical Practice Assessment Unit (CPAU) and the MI-4 Clinical Trials Platform.
The researchers would like to thank David Boulware at the University of Minnesota who created the study in the USA and with whom they have worked to make Canada's study a reality, as well as partners from University of Manitoba (Dr. Ryan Zayrchanski, principal investigator) and University of Alberta (Dr. Ilan Schwartz, principal investigator).
About the Research Institute of the MUHC
The Research Institute of the McGill University Health Centre (RI-MUHC) is a world-renowned biomedical and healthcare research centre. The Institute, which is affiliated with the Faculty of Medicine of McGill University, is the research arm of the McGill University Health Centre (MUHC) – an academic health centre located in Montreal, Canada, that has a mandate to focus on complex care within its community. The RI-MUHC supports over 420 researchers and close to 1,200 research trainees devoted to a broad spectrum of fundamental, clinical and health outcomes research at the Glen and the Montreal General Hospital sites of the MUHC. Its research facilities offer a dynamic multidisciplinary environment that fosters collaboration and leverages discovery aimed at improving the health of individual patients across their lifespan. The RI-MUHC is supported in part by the Fonds de recherche du Québec – Santé (FRQS). www.rimuhc.ca
The Clinical Practice Assessment Unit was established in 2016 through funding from the Department of Medicine. The research unit seeks to study high value healthcare and appropriate use of healthcare resources.
About MI-4 Clinical Trials Platform
The Platform provides infrastructure for operationalizing novel studies and helps support researchers in launching randomized clinical trials in infectious diseases and immunity.
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