Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 - Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19

Oct 26, 2020
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Private donors
Date Published:
10/20/2020
Date Updated:
10/26/2020
Original Posted Date:
10/26/2020
References

Contribution To Literature:

This trial failed to show that hydroxychloroquine was superior to placebo at improving symptom severity in nonhospitalized adults with early COVID-19.

Description:

The goal of the trial was to evaluate hydroxychloroquine compared with placebo among nonhospitalized patients with laboratory-confirmed or probable coronavirus disease 2019 (COVID-19) infection.

Study Design

  • Randomized
  • Parallel
  • Placebo
  • Blinded

Nonhospitalized patients with laboratory-confirmed or probable COVID-19 infection were randomized to hydroxychloroquine 800 mg once, then 600 mg in 6-8 hours, then 600 mg daily for 4 days (n = 244) versus placebo (n = 247).

  • Total number of enrollees: 491
  • Duration of follow-up: 14 days
  • Mean patient age: 41 years
  • Percentage female: 58%
  • Percentage with diabetes: 3.8%

Inclusion criteria:

  • Nonhospitalized patients with laboratory-confirmed or probable COVID-19 infection
  • Within 4 days of symptom onset

Principal Findings:

The primary outcome, change in symptom severity score from baseline to 14 days, was -2.6 in the hydroxychloroquine group compared with -2.3 in the placebo group (p = 0.12).

Secondary outcomes:

  • Medication adverse events: 43% of the hydroxychloroquine group compared with 22% of the placebo group (p < 0.001)
  • Hospitalizations: 4 in the hydroxychloroquine group compared with 10 in the placebo group (p = 0.29)

Interpretation:

Among nonhospitalized patients with laboratory-confirmed or probable COVID-19 infection, hydroxychloroquine was not beneficial. Hydroxychloroquine failed to improve a symptom severity score or reduce hospitalizations. There were more medication-adverse events in the hydroxychloroquine group. The totality of evidence, to-date, does not support the use of hydroxychloroquine for COVID-19 infection.

References:

Skipper CP, Pastick KA, Engen NW, et al. Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19: A Randomized Trial. Ann Intern Med 2020;173:623-31.

Clinical Topics: COVID-19 Hub, Prevention, Novel Agents, Statins

Keywords: Coronavirus Infections, COVID-19, Hospitalization, Hydroxychloroquine, Primary Prevention, severe acute respiratory syndrome coronavirus 2


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