ANNALS OF INTERNAL MEDICINE
Original Research16 Jul 2020
Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19.
A Randomized Trial
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.
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.
Measures: 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 .
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).
Limitations:
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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