The findings of a recent trial illustrated that in adult outpatients having symptomatic coronavirus disease 2019 (COVID-19) infection, subjects treated with fluvoxamine were found to have a reduced likelihood of clinical deterioration over 15 days in comparison with placebo.

A double-blind, randomized, placebo-controlled, fully remote/contactless clinical trial was performed to investigate whether fluvoxamine (a sigma-1 receptor agonist and selective serotonin reuptake inhibitor), administered as early therapy during mild COVID-19 prevents clinical deterioration and minimizes the severity of the disease.

The study recruited 152 non-hospitalized patients suffering from confirmed COVID-19 infection, with disease symptom onset within seven days and oxygen saturation of 92% or higher. Patients were randomly allocated to receive fluvoxamine (100 mg, n = 80) or placebo (n = 72) three times daily for about 15 days.

Clinical deterioration within 15 days of randomization defined by fulfilling both criteria of (i) decline in oxygen saturation (< 92%) on room air or supplemental oxygen requirement to maintain an oxygen saturation of 92% or greater (ii) dyspnea or hospitalization for shortness of breath or pneumonia was the primary endpoint.

Of 152 randomized patients, about 115 (76%) patients completed the trial. Compared to the placebo group, clinical deterioration occurred less in the fluvoxamine group (absolute difference of 8.7%). Fluvoxamine was found to be well tolerated. Compared to the placebo group, serious adverse event and other adverse events occurred less in the fluvoxamine group, as shown below:

The time to clinical deterioration for both the groups is shown in the following figure:

Thus, fluvoxamine may potentially benefit patients suffering from mild, symptomatic COVID-19. However, this trial is confined by a short follow-up duration and a very small sample size. Additionally, evaluation of efficacy would need further robust randomized trials with more standard outcome parameters.