Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized Trial.
Ann Intern Med
; 173(8): 623-631, 2020 10 20.
Article
in English
| MEDLINE | ID: covidwho-981646
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.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Outpatients
/
Pneumonia, Viral
/
Coronavirus Infections
/
Pandemics
/
Betacoronavirus
/
Hydroxychloroquine
Type of study:
Cohort study
/
Experimental Studies
/
Observational study
/
Prognostic study
/
Randomized controlled trials
Limits:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Language:
English
Journal:
Ann Intern Med
Year:
2020
Document Type:
Article
Similar
MEDLINE
...
LILACS
LIS