A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19
D.R. Boulware, M.F. Pullen, A.S. Bangdiwala, K.A. Pastick, S.M. Lofgren, E.C. Okafor, C.P. Skipper, A.A. Nascene, M.R. Nicol, M. Abassi, N.W. Engen, M.P. Cheng, D. LaBar, S.A. Lother, L.J. MacKenzie, G. Drobot, N. Marten, R. Zarychanski, L.E. Kelly, I.S. Schwartz, E.G. McDonald, R. Rajasingham, T.C. Lee, and K.H. Hullsiek
Abstract
BACKGROUND
Coronavirus disease 2019 (Covid-19) occurs after exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). For persons who are exposed, the
standard of care is observation and quarantine. Whether hydroxychloroquine can
prevent symptomatic infection after SARS-CoV-2 exposure is unknown.
METHODS
We conducted a randomized, double-blind, placebo-controlled trial across the
United States and parts of Canada testing hydroxychloroquine as postexposure prophylaxis. We enrolled adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes
while wearing neither a face mask nor an eye shield (high-risk exposure) or while
wearing a face mask but no eye shield (moderate-risk exposure). Within 4 days
after exposure, we randomly assigned participants to receive either placebo or
hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg
daily for 4 additional days). The primary outcome was the incidence of either laboratory-confirmed Covid-19 or illness compatible with Covid-19 within 14 days.
RESULTS
We enrolled 821 asymptomatic participants. Overall, 87.6% of the participants
(719 of 821) reported a high-risk exposure to a confirmed Covid-19 contact. The
incidence of new illness compatible with Covid-19 did not differ significantly between participants receiving hydroxychloroquine (49 of 414 [11.8%]) and those
receiving placebo (58 of 407 [14.3%]); the absolute difference was −2.4 percentage
points (95% confidence interval, −7.0 to 2.2; P=0.35). Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious
adverse reactions were reported.
CONCLUSIONS
After high-risk or moderate-risk exposure to Covid-19, hydroxychloroquine did not
prevent illness compatible with Covid-19 or confirmed infection when used as
postexposure prophylaxis within 4 days after exposure. (Funded by David Baszucki
and Jan Ellison Baszucki and others; ClinicalTrials.gov number, NCT04308668.)
CORDITE (CORona Drug InTEractions database) collects and aggregates data from PubMed, MedRxiv, BioRxiv, ChemRxiv and PMC for SARS-CoV-2. Its main focus is set on drug interactions either addressing viral proteins or human proteins that could be used to treat COVID.
It collects and provides up-to-date information on computational predictions, in vitro, as well as in vivo study data.
The information provided is for research only and we cannot guarantee the correctness of the data.
