Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: initial results of a double-blind, placebo-controlled randomized clinical trial

9/21 Pre-Exposure Prophylaxis study (treated before exposed to the virus)

Grau-Pujol et al., Research Square, doi:10.21203/rs.3.rs-72132/v1 (Preprint)
Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: initial results of a double-blind, placebo-controlled randomized clinical trial

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Small PrEP RCT showing that PrEP with HCQ is safe at the dosage used. No deaths, hospitalizations, or serious adverse events. With only one case (in the placebo arm), efficacy was not evaluated.

The abstract appears to have a typo and does not match the results section. We believe the results section is correct with one case in the control arm - the 0.8% matches the percentage for the control arm (there is no possible number of cases for the combined arms that matches 0.8%). Note that table 2 refers to risk factors, not outcomes.

A previous version of this paper was posted 9/21/20 [1].

Grau-Pujol et al., 9/21/2020, Randomized Controlled Trial, Spain, Europe, preprint, 22 authors.

risk of COVID-19 case, 67.9% lower, RR 0.32, p = 0.47, treatment 0 of 142 (0.0%), control 1 of 127 (0.8%), continuity correction due to zero event (with reciprocal of the contrasting arm).

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.

[1] researchsquare.com/article/rs-72132/v1

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