Early terminated HCQ PrEP RCT with 62 HCQ and 65 placebo patients, showing 82% lower cases with treatment, p
= 0.12. NCT04318015
If the trial is continued and the same event rate is observed, statistical significance will be reached after adding about 16 patients per arm.
Rojas-Serrano et al., 5/16/2021, Double Blind Randomized Controlled Trial, Mexico, North America, preprint, 8 authors.
risk of symptomatic case, 82.0% lower, RR 0.18, p = 0.12, treatment 1 of 62 (1.6%), control 6 of 65 (9.2%), adjusted per study.
Effect extraction follows pre-specified rules
prioritizing more serious outcomes. For an individual study the most serious
outcome may have a smaller number of events and lower statistical signficance,
however this provides the strongest evidence for the most serious outcomes
when combining the results of many trials.