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0 0.5 1 1.5 2+ Mortality 66% Improvement Relative Risk Hospitalization 24% Viral clearance 4% c19hcq.org Reis et al. NCT04403100 TOGETHER HCQ RCT LATE TREATMENT Favors HCQ Favors control
Effect of Early Treatment With Hydroxychloroquine or Lopinavir and Ritonavir on Risk of Hospitalization Among Patients With COVID-19 The TOGETHER Randomized Clinical Trial
Reis et al., JAMA Network Open, doi:10.1001/jamanetworkopen.2021.6468, TOGETHER, NCT04403100 (history)
22 Apr 2021    Source   PDF   Share   Tweet
Early terminated RCT in Brazil showing lower mortality and hospitalization with HCQ, but not reaching statistical significance. Although the title includes "early treatment", treatment was relatively late, with most patients being over 5 days from the onset of symptoms. Adverse events were lower in the HCQ group compared to the control group.
This trial appears to have been terminated at 45% enrollment while showing ≥70% probability of superiority. The futility threshold was not reported, but it would be highly unusual for it to be as high as 70% [doyourownresearch.substack.com].
The paper indicates the placebo was talc, however the trial protocol shows the "placebo" as vitamin C, for which there are 7 COVID-19 treatment studies as of April 2021 that collectively show significant efficacy.
Results differ significantly from those reported prior to publication. Prior to publication, authors reported an RR for hospitalization or death of 1.0 [0.45-2.21] [ajtmh.org].
risk of death, 66.0% lower, RR 0.34, p = 1.00, treatment 0 of 214 (0.0%), control 1 of 227 (0.4%), NNT 227, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of hospitalization, 24.0% lower, HR 0.76, p = 0.57, treatment 8 of 214 (3.7%), control 11 of 227 (4.8%), NNT 90, ITT, Cox proportional hazards.
risk of no viral clearance, 4.1% lower, RR 0.96, p = 0.10, treatment 97 of 185 (52.4%), control 102 of 179 (57.0%), NNT 22, adjusted per study, odds ratio converted to relative risk, ITT, mixed-effect logistic model.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Reis et al., 22 Apr 2021, Double Blind Randomized Controlled Trial, Brazil, peer-reviewed, 18 authors, dosage 800mg day 1, 400mg days 2-10, trial NCT04403100 (history) (TOGETHER).
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