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COVID-19 Management

RCT Results: Does Hydroxychloroquine Work for COVID-19 Postexposure Prophylaxis?

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PURPOSE:

  • Boulware et al. (NEJM, 2020) sought to determine if hydroxychloroquine can be used to prevent COVID-19 in individuals who have been exposed to SARS-CoV-2

METHODS:

  • Randomized, double-blind, placebo-controlled trial (RCT)
  • Participants:
    • Asymptomatic
    • Household or occupational exposure to individual with confirmed COVID-19 | <6 feet distance for >10 minutes
      • High-risk exposure: No face mask or eye shield
      • Moderate-risk exposure: Face mask but no eye shield
  • Randomization within 4 days post-exposure
    • Hydroxychloroquine: 800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 additional days
    • Placebo
  • Primary outcome
    • New COVID-19 (lab confirmed or compatible symptoms if testing unavailable) within 14 days
  • Secondary outcomes included
    • Hospitalization | Death | PCR-confirmed SARS-CoV-2 infection | Symptoms (severity)
  • Statistical analysis
    • Two-sided alpha of 0.05 | 90% power | 50% relative effect size
    • Require 750 participants in each group

RESULTS:

  • 821 participants
    • Hydroxychloroquine: 414
    • Placebo: 407
  • High-risk exposure: 87.6%
  • New illness compatible with COVID-19
    • No difference was detected between groups
      • Hydroxychloroquine: 11.8%
      • Placebo: 14.3%
    • Absolute difference: −2.4 percentage points (95% CI, −7.0 to 2.2; P=0.35)
  • Side effects where higher in the hydroxychloroquine group, although no severe side effects were reported
    • Hydroxychloroquine: 40.1%
    • Placebo: 16.8%

CONCLUSION:

  • The trial was stopped during interim analysis due to futility, with no significant difference between groups
  • The authors concluded

High doses of hydroxychloroquine did not prevent illness compatible with Covid-19 when initiated within 4 days after a high-risk or moderate-risk exposure

Learn More – Primary Sources:

A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19

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Related ObG Topics:

Prospective Trial Results (France): Hydroxychloroquine and Azithromycin Provide No Clinical Benefit for COVID-19
Meta-analysis of Hydroxychloroquine for the Treatment of COVID-19
NIH COVID-19 Treatment Guidelines

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