TY - JOUR
T1 - Hydroxychloroquine for pre-exposure prophylaxis of COVID-19 in health care workers
T2 - a randomized, multicenter, placebo-controlled trial Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine (HERO-HCQ)
AU - HERO Research Program
AU - Naggie, Susanna
AU - Milstone, Aaron
AU - Castro, Mario
AU - Collins, Sean P.
AU - Lakshmi, Seetha
AU - Anderson, Deverick J.
AU - Cahuayme-Zuniga, Lizbeth
AU - Turner, Kisha Batey
AU - Cohen, Lauren W.
AU - Currier, Judith
AU - Fraulo, Elizabeth
AU - Friedland, Anne
AU - Garg, Jyotsna
AU - George, Anoop
AU - Mulder, Hillary
AU - Olson, Rachel E.
AU - O'Brien, Emily C.
AU - Rothman, Russell L.
AU - Shenkman, Elizabeth
AU - Shostak, Jack
AU - Woods, Christopher W.
AU - Anstrom, Kevin J.
AU - Hernandez, Adrian F.
N1 - Funding Information:
This project was funded by the PCORI, Contract Number COVID-19-2020-001.
Publisher Copyright:
© 2023 The Authors
PY - 2023/4
Y1 - 2023/4
N2 - 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.
AB - 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.
KW - COVID-19
KW - Health care workers
KW - Hydroxychloroquine
KW - Prevention
KW - Trial design
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U2 - 10.1016/j.ijid.2023.01.019
DO - 10.1016/j.ijid.2023.01.019
M3 - Article
C2 - 36682681
AN - SCOPUS:85148341983
SN - 1201-9712
VL - 129
SP - 40
EP - 48
JO - International Journal of Infectious Diseases
JF - International Journal of Infectious Diseases
ER -