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Management of mild, symptomatic
COVID-19 illness with fluvoxamine may mitigate clinical deterioration risk.
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.
JAMA
Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19 A Randomized Clinical Trial
Eric J. Lenze et al.
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