Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized Trial.

Annals of Internal Medicine
Caleb P SkipperDavid R Boulware

Abstract

No effective oral therapy exists for early coronavirus disease 2019 (COVID-19). To investigate whether hydroxychloroquine could reduce COVID-19 severity in adult outpatients. Randomized, double-blind, placebo-controlled trial conducted from 22 March through 20 May 2020. (ClinicalTrials.gov: NCT04308668). Internet-based trial across the United States and Canada (40 states and 3 provinces). Symptomatic, nonhospitalized adults with laboratory-confirmed COVID-19 or probable COVID-19 and high-risk exposure within 4 days of symptom onset. 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. 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. 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 day...Continue Reading

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Methods Mentioned

BETA
PCR

Clinical Trials Mentioned

NCT04308668

Software Mentioned

Research Electronic Data Capture ( REDCap )
SAS

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