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Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized 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: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. PRIMARY FUNDING SOURCE:Private donors.

journal_name

Ann Intern Med

journal_title

Annals of internal medicine

authors

Skipper CP,Pastick KA,Engen NW,Bangdiwala AS,Abassi M,Lofgren SM,Williams DA,Okafor EC,Pullen MF,Nicol MR,Nascene AA,Hullsiek KH,Cheng MP,Luke D,Lother SA,MacKenzie LJ,Drobot G,Kelly LE,Schwartz IS,Zarychanski R,M

doi

10.7326/M20-4207

subject

Has Abstract

pub_date

2020-10-20 00:00:00

pages

623-631

issue

eissn

0003-4819

issn

1539-3704

journal_volume

173

pub_type

杂志文章,多中心研究,随机对照试验

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