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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).

Publication ,  Conference
Naggie, S; Milstone, A; Castro, M; Collins, SP; Lakshmi, S; Anderson, DJ; Cahuayme-Zuniga, L; Turner, KB; Cohen, LW; Currier, J; Fraulo, E ...
Published in: Int J Infect Dis
April 2023

OBJECTIVES: To determine whether hydroxychloroquine (HCQ) is safe and effective at preventing COVID-19 infections among health care workers (HCWs). METHODS: In 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). RESULTS: Study 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. CONCLUSION: Oral 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 REGISTRATION: NCT04334148.

Duke Scholars

Published In

Int J Infect Dis

DOI

EISSN

1878-3511

Publication Date

April 2023

Volume

129

Start / End Page

40 / 48

Location

Canada

Related Subject Headings

  • Treatment Outcome
  • SARS-CoV-2
  • Pre-Exposure Prophylaxis
  • Microbiology
  • Hydroxychloroquine
  • Humans
  • Health Personnel
  • COVID-19 Drug Treatment
  • COVID-19
  • 4206 Public health
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Naggie, S., Milstone, A., Castro, M., Collins, S. P., Lakshmi, S., Anderson, D. J., … HERO Research Program. (2023). 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). In Int J Infect Dis (Vol. 129, pp. 40–48). Canada. https://doi.org/10.1016/j.ijid.2023.01.019

Published In

Int J Infect Dis

DOI

EISSN

1878-3511

Publication Date

April 2023

Volume

129

Start / End Page

40 / 48

Location

Canada

Related Subject Headings

  • Treatment Outcome
  • SARS-CoV-2
  • Pre-Exposure Prophylaxis
  • Microbiology
  • Hydroxychloroquine
  • Humans
  • Health Personnel
  • COVID-19 Drug Treatment
  • COVID-19
  • 4206 Public health