The Doctors of the Therapeutic Clinic of the School of Medicine of the National and Kapodistrian University of Athens Theodora Psaltopoulou, Rodanthi Eleni Syrigou, Yannis Danasis, Panos Malandrakis, and Thanos Dimopoulos (Rector EKPA) summarize the data of the recent publication by Matthew W. McCarthy and colleagues in the prestigious scientific JAMA review comparing the efficacy of fluvoxamine versus placebo on time to recovery in outpatients with mild to moderate Covid-19 disease.
The Therapeutic Interventions and Vaccines Platform (ACTIV-6) randomized clinical trial was designed to test drugs approved for other conditions in outpatients with mild to moderate Covid-19 disease. Overall, patients were at least 30 years of age with a confirmed positive SARS-CoV-2 test and experienced 2 or more symptoms of acute Covid-19 infection for 7 or fewer days from August 6, 2021 through May 27, 2022; at 91 centers in the United States. Participants were randomized to receive 50 mg of fluvoxamine twice daily for 10 days or placebo for the corresponding days. Fluvoxamine is an antidepressant drug in the class of selective serotonin reuptake inhibitors (SSRIs).
The primary endpoint was time to recovery, i.e. time to 3 consecutive symptom-free days. Among secondary endpoints, the composite endpoint including hospitalization, emergency department visit, and death by day 28 of follow-up is of interest.
Among the 1331 randomized participants (median age 47 years), 57% were women and 67% reported receiving at least 2 doses of SARS-CoV-2 vaccine. 1288 patients completed the clinical trial (674 in the fluvoxamine group and 614 in the placebo group). The median time to recovery was 12 days in the fluvoxamine group and 13 days in the placebo group. For the composite secondary endpoint, 26 participants (3.9%) in the fluvoxamine group were hospitalized, had an urgent emergency department visit, or died compared with 23 participants (3.8%) in the placebo group. One of the participants in the fluvoxamine group and 2 of the participants in the placebo group were hospitalized. No deaths occurred during the study. Adverse events were uncommon for both groups of patients.