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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.

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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
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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
Naggie, Susanna, Aaron Milstone, Mario Castro, Sean P. Collins, Seetha Lakshmi, Deverick J. Anderson, Lizbeth Cahuayme-Zuniga, et al. “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, 129:40–48, 2023. https://doi.org/10.1016/j.ijid.2023.01.019.
Naggie S, Milstone A, Castro M, Collins SP, Lakshmi S, Anderson DJ, Cahuayme-Zuniga L, Turner KB, Cohen LW, Currier J, Fraulo E, Friedland A, Garg J, George A, Mulder H, Olson RE, O’Brien EC, Rothman RL, Shenkman E, Shostak J, Woods CW, Anstrom KJ, Hernandez AF, HERO Research Program. 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). Int J Infect Dis. 2023. p. 40–48.

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