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Safety of Hydroxychloroquine among Outpatient Clinical Trial Participants for COVID-19. | LitMetric

AI Article Synopsis

  • The study evaluated the safety of hydroxychloroquine in outpatient settings for COVID-19, specifically looking at side effects associated with its use.
  • Out of 2,795 participants, 27% reported at least one medication side effect, with gastrointestinal issues like upset stomach being the most common.
  • Overall, while mild gastrointestinal side effects were frequent, serious adverse events were rare, and no deaths were linked to hydroxychloroquine use.

Article Abstract

Introduction: Use of hydroxychloroquine in hospitalized patients with COVID-19, especially in combination with azithromycin, has raised safety concerns. Here, we report safety data from three outpatient randomized clinical trials.

Methods: We conducted three randomized, double-blind, placebo-controlled trials investigating hydroxychloroquine as pre-exposure prophylaxis, post-exposure prophylaxis and early treatment for COVID-19. We excluded individuals with contraindications to hydroxychloroquine. We collected side effects and serious adverse events. We report descriptive analyses of our findings.

Results: We enrolled 2,795 participants. The median age of research participants was 40 (IQR 34-49) years, and 59% (1633/2767) reported no chronic medical conditions. Overall 2,324 (84%) participants reported side effect data, and 638 (27%) reported at least one medication side effect. Side effects were reported in 29% with daily, 36% with twice weekly, 31% with once weekly hydroxychloroquine compared to 19% with placebo. The most common side effects were upset stomach or nausea (25% with daily, 18% with twice weekly, 16% with weekly, vs. 10% for placebo), followed by diarrhea, vomiting, or abdominal pain (23% for daily, 16% twice weekly, 12% weekly, vs. 6% for placebo). Two individuals were hospitalized for atrial arrhythmias, one on placebo and one on twice weekly hydroxychloroquine. No sudden deaths occurred.

Conclusion: Data from three outpatient COVID-19 trials demonstrated that gastrointestinal side effects were common but mild with the use of hydroxychloroquine, while serious side effects were rare. No deaths occurred related to hydroxychloroquine. Randomized clinical trials can safely investigate whether hydroxychloroquine is efficacious for COVID-19.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7386515PMC
http://dx.doi.org/10.1101/2020.07.16.20155531DOI Listing

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