Year: 2020
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: 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 laboratory-confirmed 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: = 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. PRIMARY FUNDING SOURCE: Private donors.
Source: Annals of Internal Medicine
DOI: 10.7326/m20-4207
Authors: Caleb P. Skipper, Katelyn A. Pastick, Nicole W. Engen, Ananta S. Bangdiwala, Mahsa Abassi, Sarah M. Lofgren, Darlisha A. Williams, Elizabeth C. Okafor, Matthew F. Pullen, Melanie R. Nicol, Alanna A. Nascene, Kathy H. Hullsiek, Matthew P. Cheng, Darlette Luke, Sylvain A. Lother, Lauren J. MacKenzie, Glen Drobot, Lauren E. Kelly, Ilan S. Schwartz, Ryan Zarychanski, Emily G. McDonald, Todd C. Lee, Radha Rajasingham, David R. Boulware
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W3043308024