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- Title
Hydroxychloroquine as Postexposure Prophylaxis to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 Infection : A Randomized Trial.
- Authors
Barnabas, Ruanne V.; Brown, Elizabeth R.; Bershteyn, Anna; Stankiewicz Karita, Helen C.; Johnston, Christine; Thorpe, Lorna E.; Kottkamp, Angelica; Neuzil, Kathleen M.; Laufer, Miriam K.; Deming, Meagan; Paasche-Orlow, Michael K.; Kissinger, Patricia J.; Luk, Alfred; Paolino, Kristopher; Landovitz, Raphael J.; Hoffman, Risa; Schaafsma, Torin T.; Krows, Meighan L.; Thomas, Katherine K.; Morrison, Susan
- Abstract
<bold>Background: </bold>Effective prevention against coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is currently limited to nonpharmaceutical strategies. Laboratory and observational data suggested that hydroxychloroquine had biological activity against SARS-CoV-2, potentially permitting its use for prevention.<bold>Objective: </bold>To test hydroxychloroquine as postexposure prophylaxis for SARS-CoV-2 infection.<bold>Design: </bold>Household-randomized, double-blind, controlled trial of hydroxychloroquine postexposure prophylaxis. (ClinicalTrials.gov: NCT04328961).<bold>Setting: </bold>National U.S. multicenter study.<bold>Participants: </bold>Close contacts recently exposed (<96 hours) to persons with diagnosed SARS-CoV-2 infection.<bold>Intervention: </bold>Hydroxychloroquine (400 mg/d for 3 days followed by 200 mg/d for 11 days) or ascorbic acid (500 mg/d followed by 250 mg/d) as a placebo-equivalent control.<bold>Measurements: </bold>Participants self-collected mid-turbinate swabs daily (days 1 to 14) for SARS-CoV-2 polymerase chain reaction (PCR) testing. The primary outcome was PCR-confirmed incident SARS-CoV-2 infection among persons who were SARS-CoV-2 negative at enrollment.<bold>Results: </bold>Between March and August 2020, 671 households were randomly assigned: 337 (407 participants) to the hydroxychloroquine group and 334 (422 participants) to the control group. Retention at day 14 was 91%, and 10 724 of 11 606 (92%) expected swabs were tested. Among the 689 (89%) participants who were SARS-CoV-2 negative at baseline, there was no difference between the hydroxychloroquine and control groups in SARS-CoV-2 acquisition by day 14 (53 versus 45 events; adjusted hazard ratio, 1.10 [95% CI, 0.73 to 1.66]; P > 0.20). The frequency of participants experiencing adverse events was higher in the hydroxychloroquine group than the control group (66 [16.2%] versus 46 [10.9%], respectively; P = 0.026).<bold>Limitation: </bold>The delay between exposure, and then baseline testing and the first dose of hydroxychloroquine or ascorbic acid, was a median of 2 days.<bold>Conclusion: </bold>This rigorous randomized controlled trial among persons with recent exposure excluded a clinically meaningful effect of hydroxychloroquine as postexposure prophylaxis to prevent SARS-CoV-2 infection.<bold>Primary Funding Source: </bold>Bill & Melinda Gates Foundation.
- Subjects
BILL &; Melinda Gates Foundation; COVID-19; COVID-19 treatment; HYDROXYCHLOROQUINE; SARS-CoV-2; RANDOMIZED controlled trials; STATISTICAL sampling
- Publication
Annals of Internal Medicine, 2021, Vol 174, Issue 3, p344
- ISSN
0003-4819
- Publication type
journal article
- DOI
10.7326/M20-6519