Results From the COVID-OUT Trial, a Phase-3 trial of Outpatient Treatment for Covid-19 Using Metformin, Ivermectin, and Fluvoxamine
et al. (Preprint), NCT04510194 (history)
Results for COVID-OUT were reported in a presentation, however they are not currently available due to a news embargo. There were no statistically significant results for metformin, ivermectin, or fluvoxamine, except for a post-hoc metformin composite. Null results are expected based on the trial design and size (with metformin having higher power and a greater chance of showing a result despite the design).We note that embargo and delay of clinical trial results during a pandemic is not consistent with a goal of minimizing mortality and morbidity, but is consistent with a goal of maximizing press for a trial designed to produce a null result.Treatment was 14 days for metformin and fluvoxamine, but only 3 days for ivermectin.Slides indicate that multiple imputation was used for outcomes.Trial outcomes were changed on January 20, 2022 [clinicaltrials.gov], and again on March 2, 2022 [clinicaltrials.gov (B)].
Bramante et al., 7/8/2022, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 3 authors, trial NCT04510194 (history).
Late treatment
is less effective
is less effective
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