Prospective Cohort of Fluvoxamine for Early Treatment of Coronavirus Disease 19
Updated: Sep 25, 2021
We report a real-world experience using fluvoxamine for coronavirus disease 19 (COVID-19) in a prospective cohort in the setting of a mass outbreak. Overall, 65 persons opted to receive fluvoxamine (50 mg twice daily) and 48 declined. Incidence of hospitalization was 0% (0 of 65) with fluvoxamine and 12.5% (6 of 48) with observation alone. At 14 days, residual symptoms persisted in 0% (0 of 65) with fluvoxamine and 60% (29 of 48) with observation.
In November–December 2020, a mass outbreak of COVID-19 occurred in an occupational setting with congregate living at a horse racing track in California. We instituted 3 successive rounds of mass testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with simultaneous BinaxNOW COVID-19 Antigen Cards (Abbott) coupled with polymerase chain reaction (PCR) confirmation of collected nasal swabs by the California Department of Public Health Viral and Rickettsial Disease Laboratory in Richmond, California. All PCR testing results were concordant with the Abbott BinaxNOW rapid diagnostic tests. After receiving their rapid diagnostic test results, persons with COVID-19 were required to isolate as per local health protocols. On the same day as positive rapid testing, patients were offered fluvoxamine as an optional therapy. All patients were counseled by author D.S. regarding the limited nature of the data supporting fluvoxamine. After evaluation for any specific contraindications or deleterious drug-drug interactions (none excluded), the choice was at the patient’s discretion. Fluvoxamine was prescribed with a 50- to 100-mg loading dose, then 50 mg twice daily for 14 days. The facility provided the fluvoxamine at no cost. All patients were followed up in person at 7 and 14 days. No patients were lost to follow-up.
Of 113 SARS-COV-2 antigen-positive persons, approximately half were asymptomatic when initially tested. The median age was 42 years (interquartile range, 33 to 56), and 75% were men; 84% were Latino, and 14% were white. In total, 65 persons opted for fluvoxamine, and 48 opted for observation alone with no therapy. Demographics were generally similar among those choosing fluvoxamine versus observation, with the exception that more nonwhite persons opted for fluvoxamine (Table 1). Fewer patients opting for fluvoxamine were asymptomatic (38%) at the time of initial diagnostic testing than those opting for observation (58%). Overall, 30% had 1 or more chronic medical comorbidities. Those opting for fluvoxamine had slightly more frequent diabetes (17% vs 8%) and slightly less treated hypertension (17% vs 35%) than those receiving observation.
The incidence of subsequent hospitalization was 0% (0 of 65) with fluvoxamine and 12.5% (6 of 48) with observation (P = .005). Two persons required intensive care unit stay with mechanical ventilation, 1 of whom died. Respiratory rates were slightly elevated at diagnosis and improved faster by day 7 with fluvoxamine (P = .001).On day 14, ongoing symptoms were present in 0% (0 of 65) with fluvoxamine compared with 60% (29 of 48) with observation alone (P < 0.001); 10 (21%) of whom had ≥5 persisting symptoms. The most common persisting symptoms were as follows: persistent anxiety (n = 19), difficulty concentrating/memory challenges (n = 18), fatigue (n = 16), insomnia (n = 12), myalgia/arthralgia (n = 10), and headache (n = 9). No serious adverse events occurred with fluvoxamine. No adverse events led to early discontinuation
This prospective, open-label cohort is a real-world evidence study supporting the initial observations made by Lenze et al in their 152 participant phase II double-blind randomized trial of fluvoxamine for early COVID-19 therapy as well as providing evidence of patient tolerability using a lower dose of 50 mg twice daily. Limitations include the quasi-randomized nature of the comparison; however, if anything, one would expect confounding by indication whereby those with worse symptoms would opt for fluvoxamine over observation alone. Since the initial quality improvement review, 12 additional patients at the facility have been treated with 50 mg of fluvoxamine twice daily with similar outcomes of no hospitalizations and no ongoing symptoms at 14 days, bringing the total to 77 patients treated.
Overall, fluvoxamine seems to be promising as an early treatment for COVID-19 to prevent clinical deterioration requiring hospitalization and to prevent possible long haul symptoms persisting beyond 2 weeks. Further randomized trial evidence is needed. On December 17, 2020, a new nationwide, internet-based phase III randomized trial began to confirm these initial results for those with ≤6 days of COVID-19 symptoms ClinicalTrials.gov: NCT04668950). For patients uninterested in participating in clinical trials, healthcare providers might consider shared decision-making with patients to discuss fluvoxamine as an option, after reviewing possible drug-drug interactions (eg, benzodiazepines). However, participation in clinical trials contributes to the world’s medical knowledge of how best to treat COVID-19.
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