The devastating nature of COVID-19 is well-known at this point. Its status as a global pandemic speaks volumes to the impact this virus and associated illness have had on the world.

As doctors and researchers continue to try to develop a more comprehensive understanding of COVID-19 and its effect on those who become ill, they are also scrambling to find medications and treatment methods that are effective in limiting the damage it causes.

One of the concerns associated with COVID-19 is that it triggers an excessive immune response, which can lead to clinical deterioration. Recently, researchers set out to test the effectiveness of fluvoxamine in preventing this outcome in patients with mild COVID-19.

The Study

 

This contactless study compared fluvoxamine to a placebo. Participants were non-hospitalized adults who were confirmed to have COVID-19. The participants numbered 152 adults from the St. Louis metropolitan area, and the study spanned approximately four months—April 10 to August 5. Follow-up was conducted on September 19.

The goal was to determine whether fluvoxamine limited clinical deterioration within 5 days of administration. Clinical deterioration was defined as meeting two criteria—shortness of breath (including hospitalization for shortness of breath or pneumonia) and less than 92% oxygen saturation or the need for supplemental oxygen to reach levels of 92% or greater.

Participants were randomly divided into two groups—one received 100 mg of fluvoxamine three times a day, and the other received a placebo.

Results

115 of the 152 original participants finished the trial. None of the 80 in the fluvoxamine group experienced clinical deterioration, while 6 of the 72 who received the placebo did. Serious adverse events occurred in one fluvoxamine participant and six placebo participants. Other adverse events occurred in 11 and 12 participants, respectively.

What it Means

The immediate impression is hopeful, as the study indicates that fluvoxamine is, in fact, effective in preventing clinical deterioration in adults with symptomatic COVID-19. While this interpretation is true—the study does demonstrate the effectiveness of fluvoxamine over a placebo—the study is too limited to truly determine the clinical efficacy of these findings.

Sample size and follow-up duration are two of the primary factors that would need to be expanded to gain a more accurate understanding of fluvoxamine’s effect on clinical deterioration in COVID-19 patients. Adding more definitive outcome measures would also contribute to a study being more comprehensive.