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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Hydroxychloroquine in nonhospitalized adults with early covid-19: A randomized trial
Annals of Internal Medicine, Volume 173, No. 8, Year 2020
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Description
Background: No effective oral therapy exists for early coronavirus disease 2019 (COVID-19). Objective: To investigate whether hydroxychloroquine could reduce COVID-19 severity in adult outpatients. Design: Randomized, double-blind, placebo-controlled trial conducted from 22 March through 20 May 2020. (ClinicalTrials .gov: NCT04308668) Setting: Internet-based trial across the United States and Canada (40 states and 3 provinces). Participants: Symptomatic, nonhospitalized adults with laboratoryconfirmed COVID-19 or probable COVID-19 and high-risk exposure within 4 days of symptom onset. Intervention: Oral hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 more days) or masked placebo. Measurements: Symptoms and severity at baseline and then at days 3, 5, 10, and 14 using a 10-point visual analogue scale. The primary end point was change in overall symptom severity over 14 days. Results: Of 491 patients randomly assigned to a group, 423 contributed primary end point data. Of these, 341 (81%) had laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or epidemiologically linked exposure to a person with laboratory-confirmed infection; 56% (236 of 423) were enrolled within 1 day of symptoms starting. Change in symptom severity over 14 days did not differ between the hydroxychloroquine and placebo groups (difference in symptom severity: Relative, 12%; absolute, _0.27 point [95% CI, _0.61 to 0.07 point]; P = 0.117). At 14 days, 24% (49 of 201) of participants receiving hydroxychloroquine had ongoing symptoms compared with 30% (59 of 194) receiving placebo (P = 0.21). Medication adverse effects occurred in 43% (92 of 212) of participants receiving hydroxychloroquine versus 22% (46 of 211) receiving placebo (P < 0.001). With placebo, 10 hospitalizations occurred (2 non-COVID-19-related), including 1 hospitalized death. With hydroxychloroquine, 4 hospitalizations occurred plus 1 nonhospitalized death (P = 0.29). Limitation: Only 58% of participants received SARS-CoV-2 testing because of severe U.S. testing shortages. Conclusion: Hydroxychloroquine did not substantially reduce symptom severity in outpatients with early, mild COVID-19. © 2020 American College of Physicians. All rights reserved.
Authors & Co-Authors
Skipper, Caleb P.
United States, Minneapolis
University of Minnesota Twin Cities
Pastick, Katelyn A.
United States, Minneapolis
University of Minnesota Twin Cities
Engen, Nicole Wyman
United States, Minneapolis
University of Minnesota Twin Cities
Bangdiwala, Ananta Shrikant
United States, Minneapolis
University of Minnesota Twin Cities
Abassi, Mahsa
United States, Minneapolis
University of Minnesota Twin Cities
Lofgren, Sarah M.
United States, Minneapolis
University of Minnesota Twin Cities
Williams, Darlisha A.
United States, Minneapolis
University of Minnesota Twin Cities
Okafor, Elizabeth C.
United States, Minneapolis
University of Minnesota Twin Cities
Pullen, Matthew F.
United States, Minneapolis
University of Minnesota Twin Cities
Nicol, Melanie R.
United States, Minneapolis
University of Minnesota Twin Cities
Hullsiek, Katherine Huppler
United States, Minneapolis
University of Minnesota Twin Cities
Cheng, Matthew P.
Canada, Montreal
L'institut de Recherche du Centre Universitaire de Santé Mcgill
Schwartz, Ilan S.
Canada, Edmonton
University of Alberta
Zarychanski, Ryan
Canada, Winnipeg
University of Manitoba
McDonald, Emily G.
Canada, Montreal
L'institut de Recherche du Centre Universitaire de Santé Mcgill
Lee, Todd Campbell
Canada, Montreal
L'institut de Recherche du Centre Universitaire de Santé Mcgill
Rajasingham, Radha
United States, Minneapolis
University of Minnesota Twin Cities
Boulware, David R.
United States, Minneapolis
University of Minnesota Twin Cities
Statistics
Citations: 374
Authors: 18
Affiliations: 4
Identifiers
Doi:
10.7326/M20-4207
ISSN:
00034819
Research Areas
Covid
Disability
Health System And Policy
Study Design
Randomised Control Trial