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0 0.5 1 1.5 2+ Mortality, day 28 3% Improvement Relative Risk Mortality, day 14 -197% Death/hospitalization 52% Progression 40% Progression (b) 12% primary c19early.org/mf Bramante et al. NCT04510194 COVID-OUT Metformin RCT EARLY Favors metformin Favors fluvoxamine ..
Randomized Trial of Metformin, Ivermectin, and Fluvoxamine for Covid-19
Bramante et al., NEJM, doi:10.1056/NEJMoa2201662, COVID-OUT, NCT04510194 (history)
18 Aug 2022    Source   PDF   Share   Tweet
COVID-OUT remotely operated RCT, showing lower combined ER/hospitalization/death with metformin. Results for other treatments are listed separately - ivermectin, fluvoxamine.
The "control" group includes patients receiving active treatments fluvoxamine and ivermectin.
Control arm results are very different between treatments, for example considering hospitalization/death, this was 1.0% for ivermectin vs. 2.7% for overall control, however it was 1.3% for the ivermectin-specific control. 394 control patients are shared. The rate for the non-shared 261 metformin control patients is 5%, compared to 1.3% for ivermectin control patients. The metformin arm started earlier, however it is unclear why the difference in outcomes is so large.
Results were delayed for 6 months with no explanation, with followup ending Feb 14, 2022.
Adherence was very low, with 77% overall reporting 70+% adherence. Numbers for 100% adherence are not provided.
Multiple outcomes are missing, for example time to recovery (where ACTIV-6 showed superiority of ivermectin).
Treatment was 14 days for metformin and fluvoxamine, but only 3 days for ivermectin.
Trial outcomes were changed on January 20, 2022 [clinicaltrials.gov], and again on March 2, 2022 [clinicaltrials.gov (B)]. COVIDOUT.
Medication delivery varied significantly over the trial. In this presentation [vimeo.com], author indicates that delivery was initially local, later via FedEx, was much slower in August, there were delays due to team bandwidth issues, and they only realized they could use FedEx same day delivery in September.
risk of death, 2.9% lower, RR 0.97, p = 1.00, treatment 1 of 408 (0.2%), control 1 of 396 (0.3%), NNT 13464, day 28.
risk of death, 197.1% higher, RR 2.97, p = 1.00, treatment 1 of 408 (0.2%), control 0 of 396 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm), day 14.
risk of death/hospitalization, 52.3% lower, RR 0.48, p = 0.09, treatment 8 of 652 (1.2%), control 18 of 655 (2.7%), NNT 66, odds ratio converted to relative risk.
risk of progression, 40.2% lower, RR 0.60, p = 0.03, treatment 27 of 652 (4.1%), control 48 of 655 (7.3%), NNT 31, odds ratio converted to relative risk, combined ER, hospitalization, death.
risk of progression, 12.1% lower, RR 0.88, p = 0.18, treatment 154 of 652 (23.6%), control 179 of 653 (27.4%), NNT 26, odds ratio converted to relative risk, combined hypoxemia, ER, hospitalization, death, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Bramante et al., 18 Aug 2022, Double Blind Randomized Controlled Trial, placebo-controlled, USA, peer-reviewed, 3 authors, average treatment delay 4.8 days, this trial compares with another treatment - results may be better when compared to placebo, trial NCT04510194 (history) (COVID-OUT).
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