Journal
CLINICAL INFECTIOUS DISEASES
Volume 72, Issue 11, Pages E835-E843Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/cid/ciaa1571
Keywords
COVID-19; hydroxychloroquine; healthcare workers; pre-exposure prophylaxis
Categories
Funding
- National Institute of Allergy and Infectious Diseases [K08AI134262, K23AI138851, T32AI055433]
- National Institute of Mental Health [K23MH121220]
- combined Fogarty International Center Global Fellows Scholarship/National Institute of Neurological Disorders and Stroke grant [D43TW009345]
- Doris Duke Charitable Foundation
- National Institutes of Health [T32GM007347, F30CA236157]
- Manitoba Medical Service Foundation
- National Institutes of Health's National Center for Advancing Translational Sciences [UL1TR002494]
- Research Manitoba
- Rainwater Charitable Foundation
- Alliance of Minnesota Chinese Organizations
- Minnesota Chinese Chamber of Commerce
- University of Minnesota Foundation
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A clinical trial investigating hydroxychloroquine prophylaxis for healthcare workers at high risk of exposure to SARS-CoV-2 found that once-weekly or twice-weekly dosing did not significantly reduce the incidence of laboratory-confirmed COVID-19 or COVID-19-compatible illness.
Background. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging virus causing the ongoing coronavirus disease 2019 (COVID-19) pandemic with no known effective prophylaxis. We investigated whether hydroxychloroquine could prevent SARS-CoV-2 in healthcare workers at high risk of exposure. Methods. We conducted a randomized, double-blind, placebo-controlled clinical trial of healthcare workers with ongoing exposure to persons with SARS-CoV-2, including those working in emergency departments, intensive care units, COVID-19 hospital wards, and first responders. Participants across the United States and in the Canadian province of Manitoba were randomized to hydroxychloroquine loading dose then 400 mg once or twice weekly for 12 weeks. The primary endpoint was confirmed or probable COVID-19-compatible illness. We measured hydroxychloroquine whole-blood concentrations. Results. We enrolled 1483 healthcare workers, of whom 79% reported performing aerosol-generating procedures. The incidence of COVID-19 (laboratory-confirmed or symptomatic compatible illness) was 0.27 events/person-year with once-weekly and 0.28 events/person-year with twice-weekly hydroxychloroquine compared with 0.38 events/person-year with placebo. For once-weekly hydroxychloroquine prophylaxis, the hazard ratio was .72 (95% CI, .44-1.16; P=.18) and for twice-weekly was .74 (95% CI, .46-1.19; P=.22) compared with placebo. Median hydroxychloroquine concentrations in whole blood were 98 ng/mL (IQR, 82-120) with once-weekly and 200 ng/mL (IQR, 159-258) with twice-weekly dosing. Hydroxychloroquine concentrations did not differ between participants who developed COVID-19-compatible illness (154 ng/mL) versus participants without COVID-19 (133 ng/mL; P=.08). Conclusions. Pre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed COVID-19 or COVID-19-compatible illness among healthcare workers.
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