Hydroxychloroquine for COVID-19 Post-Exposure Prophylaxis - Hydroxychloroquine COVID-19 PEP

Dec 14, 2020
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Bill and Melinda Gates Foundation
Date Published:
12/08/2020
Date Updated:
12/14/2020
Original Posted Date:
12/14/2020
References

Contribution To Literature:

Among patients exposed to patients with SARS-CoV-2, hydroxychloroquine, administered within a median duration of 2 days as post-exposure prophylaxis, did not reduce the incidence of SARS-CoV-2 or COVID-19 infection within 14 days, compared with placebo (vitamin C).

Description:

The goal of the trial was to assess the safety and efficacy of hydroxychloroquine as post-exposure prophylaxis for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

Study Design

Patients were randomized in a 1:1 fashion to either hydroxychloroquine (400 mg/d orally for 3 days, then 200 mg/d orally for an additional 11 days) or ascorbic acid (500 mg/d orally for 3 days, then 250 mg/d orally for 11 days) as a placebo equivalent.

  • Total screened: 943
  • Total number of enrollees: 829 participants (671 households)
  • Duration of follow-up: 14 days
  • Median age: 39 years
  • Percentage female: 60%

Inclusion criteria:

  • Ages 18–80 years
  • Close contact with a person (index) with recent known SARS-CoV-2 infection (household contacts of an index person diagnosed within the past 14 days or health care workers who cared for an index case without appropriate personal protective equipment)
  • Exposure within the prior 96 hours
  • Able to conduct study visits via telehealth
  • Not planning to take hydroxychloroquine outside the study

Exclusion criteria:

  • Symptoms consistent with SARS-CoV-2 infection
  • Hospitalized
  • Hydroxychloroquine was medically contraindicated

Other salient features/characteristics:

  • Median self-reported hours of exposure: 12 hours
  • Median days between exposure and study drug: 2 days
  • Health care worker: 18%
  • Currently quarantined: 57%

Principal Findings:

The primary outcome, SARS-CoV-2 infection in the first 14 days post-exposure, for hydroxychloroquine vs. placebo, was 53 vs. 45 events (hazard ratio 1.1, 95% confidence interval 0.73–1.66, p > 0.20).

Secondary analyses for hydroxychloroquine vs. placebo:

  • SARS-CoV-2 infection in the first 28 days post-exposure, for hydroxychloroquine vs. placebo: 58 vs. 48 events (p > 0.20)
  • COVID-19 diagnosis: 43 vs. 33 (p > 0.20)
  • Diarrhea, abdominal discomfort, vomiting: 6.1% vs. 1.7%

Interpretation:

The results of this trial indicate that among patients exposed to patients with SARS-CoV-2, hydroxychloroquine, administered within a median duration of 2 days as post-exposure prophylaxis, did not reduce the incidence of SARS-CoV-2 or COVID-19 infection with 14 days, compared with placebo (vitamin C). There was a higher incidence of gastrointestinal and dermatological side effects with hydroxychloroquine, although the incidence of serious side effects was similar.

Although this was a smaller study, the lack of effect shown in this study builds on other recent data and provides evidence against the routine use of hydroxychloroquine for SARS-CoV-2 post-exposure prophylaxis, a practice that is fairly common in many parts of the world.

References:

Barnabas RV, Brown ER, Bershteyn A, et al., on behalf of the Hydroxychloroquine COVID-19 PEP Study Team. Hydroxychloroquine as Postexposure Prophylaxis to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 Infection: A Randomized Trial. Ann Intern Med 2020;Dec 8:[Epub ahead of print].

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

Keywords: Ascorbic Acid, Coronavirus Infections, COVID-19, Diarrhea, Health Personnel, Hydroxychloroquine, Personal Protective Equipment, Post-Exposure Prophylaxis, Primary Prevention, Quarantine, severe acute respiratory syndrome coronavirus 2, Telemedicine, Vomiting


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