학술논문
Hydroxychloroquine for pre-exposure prophylaxis of COVID-19 in health care workers: a randomized, multicenter, placebo-controlled trial Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine (HERO-HCQ)
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article
Author
Naggie, Susanna; Milstone, Aaron; Castro, Mario; Collins, Sean P; Lakshmi, Seetha; Anderson, Deverick J; Cahuayme-Zuniga, Lizbeth; Turner, Kisha Batey; Cohen, Lauren W; Currier, Judith; Fraulo, Elizabeth; Friedland, Anne; Garg, Jyotsna; George, Anoop; Mulder, Hillary; Olson, Rachel E; O'Brien, Emily C; Rothman, Russell L; Shenkman, Elizabeth; Shostak, Jack; Woods, Christopher W; Anstrom, Kevin J; Hernandez, Adrian F; Program, HERO Research
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Abstract
ObjectivesTo determine whether hydroxychloroquine (HCQ) is safe and effective at preventing COVID-19 infections among health care workers (HCWs).MethodsIn a 1: 1 randomized, placebo-controlled, double-blind, parallel-group, superiority trial at 34 US clinical centers, 1360 HCWs at risk for COVID-19 infection were enrolled between April and November 2020. Participants were randomized to HCQ or matched placebo. The HCQ dosing included a loading dose of HCQ 600 mg twice on day 1, followed by 400 mg daily for 29 days. The primary outcome was a composite of confirmed or suspected COVID-19 clinical infection by day 30, defined as new-onset fever, cough, or dyspnea and either a positive SARS-CoV-2 polymerase chain reaction test (confirmed) or a lack of confirmatory testing due to local restrictions (suspected).ResultsStudy enrollment closed before full accrual due to recruitment challenges. The primary end point occurred in 41 (6.0%) participants receiving HCQ and 53 (7.8%) participants receiving placebo. No difference in the proportion of participants experiencing clinical infection (estimated difference of -1.8%, 95% confidence interval -4.6-0.9%, P = 0.20) was identified nor any significant safety issues.ConclusionOral HCQ taken as prescribed appeared safe among HCWs. No significant clinical benefits were observed. The study was not powered to detect a small but potentially important reduction in infection.Trial registrationNCT04334148.