null Could an antidepressant slow COVID-19 progression?
RI-MUHC researchers launch a clinical trial of fluvoxamine, a drug that has already proven efficient in reducing lung injury in animal studies and a small placebo-controlled trial
At a time when the number of patients hospitalized with COVID-19 is putting the health care system at risk, and governments are imposing new restrictions on the population, researchers at the Research Institute of the McGill University Health Centre (RI-MUHC) are continuing to test the efficacy of different drugs that could reduce COVID-19 hospitalizations.
After conducting clinical trials of hydroxychloroquine in the spring of 2020, Dr. Emily McDonald, Investigator at the RI-MUHC and Director of the MUHC Clinical Practice Assessment Unit, and Dr. Todd C. Lee, Scientist at the RI-MUHC and Associate Professor of Medicine, Division of Infectious Diseases at McGill University, are launching the Canadian arm of the STOP COVID2 clinical trial, currently underway in the United States. This randomized placebo-controlled trial aims to confirm the effectiveness of fluvoxamine, a common antidepressant, in slowing the progression of symptoms associated with COVID-19. A previous trial—STOP COVID—showed that fluvoxamine was associated with a reduction in clinical worsening in people with COVID-19, as published in November 2020 in the Journal of the American Medical Association.
“In the STOP COVID trial, 0 of 80 patients in the fluvoxamine group and 6 of 72 patients in the placebo group experienced clinical worsening," says Dr. McDonald, the study's principal investigator, who is also Assistant Professor of Medicine at McGill University. “That's a difference that is statistically significant. We now hope to corroborate those results in a larger sample.”
Fluvoxamine is a safe, inexpensive medication approved by Health Canada for the treatment of depression and obsessive-compulsive disorder. Researchers will determine if it reduces the risk of developing severe shortness of breath, requiring oxygen, and being hospitalized for COVID-19, and whether it reduces long-term symptoms due to COVID-19, or so-called “COVID long-haulers.”
“Drug repurposing allows new treatments to be tested faster than new drug development," says Dr. Lee, co-principal investigator. “Based on the promising results of the previous clinical trial, we have high hopes that this drug may prevent hospitalization and reduce the strain on the healthcare system.”
The participants will receive a safe dosage of fluvoxamine (or placebo) at home, as well as a thermometer and a finger oxygen saturation monitor, that they will be able to keep. They will be asked to take the medicine they have received, to measure their temperature and oxygen levels, and fill out a short online questionnaire twice a day for 15 days. Lastly, they will complete a final survey on day 90.
The trial is open to non-hospitalized adults with a positive test result for SARS-CoV-2 who have had symptoms of COVID-19 for no more than 6 days, and who have a risk factor for clinical deterioration related to either their age (40 years or older), their race or ethnic group (African Canadian, Hispanic or Indigenous), or a medical condition (such as asthma, high blood pressure, being overweight or with diabetes). There are also a number of exclusions meant to ensure the safe use of fluvoxamine. At this time, the study is open to all residents of Quebec, but the research team is working to make it available across the country.
Enrollment in the study is contactless – registration is done online at stopcovid2.idtrials.com. All necessary information, including frequently asked questions, are available on the site in English and French.
This clinical study is made possible through funding from the Department of Medicine’s Clinical Practice Assessment Unit.
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
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January 11, 2021