Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19
MD Caleb P Skipper, BSc Katelyn A Pastick, MS Nicole W Engen, MS Ananta S Bangdiwala, DO, MPH Mahsa Abassi, MD Sarah M Lofgren, MPH Darlisha A Williams, BSc Elizabeth C Okafor, MD Matthew F Pullen, PharmD Melanie R Nicol, PhD Alanna A Nascene, BA Kathy H Hullsiek, PhD Matthew P Cheng, MD Darlette Luke, PharmD Sylvain A Lother, MD Lauren J Mackenzie, MD, MPH Glen Drobot, MD Lauren E Kelly, PhD Ilan S Schwartz, PhD Ryan Zarychanski, MD, MSc Emily G Mcdonald, MD, MSc Todd C Lee, MD, MPH Radha Rajasingham, MD David R Boulware
Annals of Internal Medicine, doi:10.7326/m20-4207
Background: No effective oral therapy exists for early coronavirus disease 2019 . 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. 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.
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