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COVID-19 Management

Does Hydroxychloroquine Provide Benefit in Nonhospitalized Patients with Early COVID-19 Infection?

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PURPOSE:

  • Skipper et al. (Annals of Internal Medicine, 2020) sought to determine if hydroxychloroquine is of benefit to individuals with COVID-19 early in their clinical course  

METHODS:

  • Multisite, international, randomized, double-blind, placebo-controlled trial (March 22 through May 20, with final hospital outcomes available June 15, 2020)  
    • 40 states (US) | 3 provinces (Canada)
    • Researchers collected self-reported survey data using the Research Electronic Data Capture (REDCap) system | Outreach traditional and through social media
  • Participants
    • Nonhospitalized | ≤4 days of symptoms with
      • Laboratory-confirmed COVID-19 or COVID-19–compatible symptoms and in contact with COVID-19 positive individual
    • Symptomatic health care workers with high-risk exposure but whose contact had PCR results pending were also included
  • Randomized 1:1 to the following
    • Oral hydroxychloroquine: 800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 more days
    • Masked placebo
  • Measurements
    • Symptoms and severity at baseline and then at days 3, 5, 10, and 14
    • Assessed using a 10-point visual analogue scale
  • Outcomes
    • The primary end point was changed to an overall symptom severity score over the course of 14 days

RESULTS:

  • 423 contributed primary end point data (out of 491 randomized)
    • Median age: 40 years | 56% women | Identified as Black or African American were underrepresented (3%)  
    • Enrolled within 1 day of onset of symptoms: 56% (236 of 423)
  • Change in symptom severity over 14 days did not differ between groups
    • Absolute difference in symptom severity: −0.27 points (95% CI, −0.61 to 0.07 points; P=0.117)
  • There was no difference in proportion of patients with ongoing symptoms at 14 days (P=0.21)
    • Hydroxychloroquine: 24%
    • Placebo: 30%
  • Medication adverse effects were more frequent with hydroxychloroquine (P < 0.001)
    • Hydroxychloroquine: 43%
    • Placebo: 22%
  • There was no significant difference in hospitalization or death (P = 0.29)
    • Hydroxychloroquine: 4 hospitalizations occurred | 1 nonhospitalized death
    • Placebo: 10 hospitalizations (2 non–COVID-19–related) | 1 hospitalized death

CONCLUSION:

  • The authors note that the population was relatively young, with few comorbid conditions and therefore these outcomes may not be generalizable to all population groups | A substantial proportion of patients were enrolled based on symptoms and not SARS-CoV-2 testing (due to limited availability)
  • The authors conclude that

Hydroxychloroquine did not substantially reduce symptom severity in outpatients with early, mild COVID-19

Learn More – Primary Sources:

Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19

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