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Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized Trial.
- Source :
-
Annals of internal medicine [Ann Intern Med] 2020 Oct 20; Vol. 173 (8), pp. 623-631. Date of Electronic Publication: 2020 Jul 16. - Publication Year :
- 2020
-
Abstract
- Background: No effective oral therapy exists for early coronavirus disease 2019 (COVID-19).<br />Objective: To investigate whether hydroxychloroquine could reduce COVID-19 severity in adult outpatients.<br />Design: Randomized, double-blind, placebo-controlled trial conducted from 22 March through 20 May 2020. (ClinicalTrials.gov: NCT04308668).<br />Setting: Internet-based trial across the United States and Canada (40 states and 3 provinces).<br />Participants: Symptomatic, nonhospitalized adults with laboratory-confirmed COVID-19 or probable COVID-19 and high-risk exposure within 4 days of symptom onset.<br />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.<br />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.<br />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).<br />Limitation: Only 58% of participants received SARS-CoV-2 testing because of severe U.S. testing shortages.<br />Conclusion: Hydroxychloroquine did not substantially reduce symptom severity in outpatients with early, mild COVID-19.<br />Primary Funding Source: Private donors.
- Subjects :
- Adult
Antimalarials therapeutic use
COVID-19
Coronavirus Infections epidemiology
Double-Blind Method
Female
Follow-Up Studies
Humans
Male
Middle Aged
Pneumonia, Viral epidemiology
Retrospective Studies
Risk Factors
SARS-CoV-2
Time Factors
Betacoronavirus
Coronavirus Infections drug therapy
Hydroxychloroquine therapeutic use
Outpatients
Pandemics
Pneumonia, Viral drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1539-3704
- Volume :
- 173
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- Annals of internal medicine
- Publication Type :
- Academic Journal
- Accession number :
- 32673060
- Full Text :
- https://doi.org/10.7326/M20-4207