Effect of Fluvoxamine and Metformin for Fatigue in Patients With Long COVID
et al., Annals of Internal Medicine, doi:10.7326/ANNALS-26-02144, REVIVE-TOGETHER, NCT06128967, Oct 2026
Metformin for COVID-19
Lower risk for mortality, ventilation, ICU, hospitalization, progression, recovery, and viral clearance.
No treatment is 100% effective.
Protocols combine treatments.
RCT 399 long COVID patients in Brazil showing reduced fatigue with fluvoxamine, and inconclusive results for metformin.
This is a republication of a retracted paper1. Metformin was reduced from 750mg to 500mg bid in May 2024, and the arm was stopped for futility in September 2024.
The original version was retracted for not reporting the dose change. The stated reason for that change, a 9% rate of withdrawal for gastrointestinal side effects, appears to conflict with the trial's own data: only 2.8% of the 750mg cohort had gastrointestinal adverse events, and 98% of the metformin arm completed follow-up.
The only published protocol that includes fluvoxamine is dated April 2024, although the paper describes three-arm randomization from October 2023. The analysis plan dated "April 2024" cites a 2026 journal request.
The fluvoxamine arm's median time since infection (870 days) exceeds even the amended 24-month window. The day 60 effect is below the 0.45 minimal important difference that was used to power the trial, the unadjusted difference in mean FSS change was only 0.26 points, and stopping early for efficacy may overestimate benefit. The fatigue score is self-reported and could be affected by fluvoxamine's antidepressant action (EQ-5D anxiety/depression scores also improved). Missing day 90 follow-up was higher with fluvoxamine, 13% vs. 6%, and the placebo arm had higher baseline fatigue. Reported side effects appear to be implausibly rare, with fewer adverse events in the fluvoxamine arm than placebo and gastrointestinal events no higher than placebo, suggesting incomplete adverse event capture or poor adherence.
Study covers fluvoxamine and metformin.
Reis et al., 6 Oct 2026, Double Blind Randomized Controlled Trial, Brazil, peer-reviewed, 97 authors, study period 18 October, 2023 - 10 February, 2025, trial NCT06128967 (history) (REVIVE-TOGETHER).
Contact: millsej@mcmaster.ca, reisg1@mcmaster.ca.
DOI record:
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Late treatment
is less effective
is less effective
reis16