A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19
David R Boulware, Matthew F Pullen, Ananta S Bangdiwala, Katelyn A Pastick, Sarah M Lofgren, Elizabeth C Okafor, Caleb P Skipper, Alanna A Nascene, Melanie R Nicol, Mahsa Abassi, Nicole W Engen, Matthew P Cheng, Derek Labar, Sylvain A Lother, Lauren J Mackenzie, Glen Drobot, Nicole Marten, Ryan Zarychanski, Lauren E Kelly, Ilan S Schwartz, Emily G Mcdonald, Radha Rajasingham, Todd C Lee, Kathy H Hullsiek
New England Journal of Medicine, doi:10.1056/nejmoa2016638
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.
n engl j med nejm.org
8 T h e ne w e ngl a nd jou r na l o f m e dicine exposure prophylaxis would be effective in highrisk populations is a separate question, with trials ongoing. In order to end the pandemic, a reduction in community transmission is needed. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. A data sharing statement provided by the authors is available with the full text of this article at NEJM.org. We thank the participants who consented to participate in this randomized trial; the members of the data and safety monitoring board (Drs. George Thompson III, Andrej Spec, Tom Chiller, and Bozena Morawski) for their thoughtful, generous service; and Drs. Jakub Tolar, Alexis Turgeon, Brad Benson, Tim Schacker, and Peter Igarashi for institutional support. Dr. Boulware thanks Drs. Paul Bohjanen and Ed Janoff for their mentorship. * Values are through day 5, the date of the scheduled completion of the trial intervention. More than one side effect could occur. Ongoing side effects were reported by approximately 3% of the participants in the hydroxychloroquine group at days 10 and 14 and by less than 1% of those in the placebo group. There was no association between the occurrence of side effects and the incidence of Covid-19. Among participants in whom Covid-19 developed, 30.0% (30 of 100) reported a side effect, as compared with 28.2% (169 of 600) reporting a side effect in whom Covid-19 did not develop (P =..
DOI record:
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