Is fluvoxamine, a common antidepressant, effective in slowing the progression of symptoms of COVID-19? This is the question that researchers at the Research Institute of the McGill University Health Center will be examining (RI-MUHC).
In fact, doctors Todd Lee and Emily McDonald launch the Canadian part of the clinical trial STOP COVID2 currently underway in the United States.
This clinical trial on fluvoxamine follows the STOP COVID trial, which the results published in November 2020 in the Journal of the American Medical Association have shown the drug to be associated with reduced clinical deterioration in people with COVID-19.
The fluvoxamine is an inexpensive, Health Canada-approved drug for depression and obsessive-compulsive disorder.
Drug reassignment allows new treatments to be tested faster than new drug development, says Dr. Todd Lee. Given the promising results of the previous clinical trial, he is optimistic that fluvoxamine can prevent hospitalization and reduce the strain on the healthcare system.
Promising results against COVID-19
In the first trial, none of the 80 patients assigned to the fluvoxamine group and 6 of the 72 patients assigned to the placebo group suffered clinical deterioration, explains Dr. Emily McDonald. “It’s a statistically significant difference,” she adds.
However, the study is limited by a small sample size, as well as a short duration of follow-up. Determining clinical efficacy would require larger randomized trials with more definitive outcome measures.
“We now hope to corroborate these results with a larger sample,” says Dr. McDonald.
It remains to be seen whether fluvoxamine reduces the risk of developing severe shortness of breath, requiring oxygen, and being hospitalized due to COVID-19. Researchers will also check if it decreases persistent symptoms of COVID-19.
Second clinical trial
The second clinical trial is open to non-hospitalized adults who test positive for SARS-CoV-2.
They must also show symptoms of COVID-19 for a maximum of 6 days and have a risk factor for clinical deterioration related either to 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, overweight or diabetes).
There are also a number of exclusions aimed at ensuring the safe use of fluvoxamine. For now, the study is open to all residents of Quebec. However, the research team is working to make it available across the country.
During the clinical trial, participants will receive a dosage of fluvoxamine (or a placebo), a thermometer and an oxygen saturation meter at home. They will have to take the medication received, measure their temperature and oxygen level, and complete a brief online questionnaire, twice a day for 15 days. Finally, they will take a final survey on the 90th day.
Registration for the study is done without contact, on the site stopcovid2.idtrials.com.