Safety of hydroxychloroquine for treatment or prevention of SARS-CoV-2 infection: A rapid systematic review and meta-analysis of randomized clinical trials

Immun Inflamm Dis. 2021 Mar;9(1):31-36. doi: 10.1002/iid3.374. Epub 2020 Nov 26.


Introduction: Hydroxycloroquine (HCQ) has been extensively studied for treatment and prevention of coronavirus diseases 2019 (COVID-19) from the start of the pandemic. Conflicting evidence about its usefulness has begun to accrue.

Methods: In the face of controversial results about clinical efficacy of HCQ, we performed a rapid systematic review to assess its safety in the framework of COVID-19 randomized clinical trials.

Results: Five studies investigating 2291 subjects were included. The use of HCQ was associated with higher risk of adverse event compared with placebo or standard of care: odds ratio 4.57, 95% confidence interval 2.14-9.45.

Conclusion: Safety profile of HCQ appears to be unsatisfactory when used to treat or prevent COVID-19, especially in the light of unproved clinical benefit.

Keywords: COVID-19; SARS-CoV-2; hydroxychloroquine; meta-analysis; randomized controlled trials; safety.

Publication types

  • Meta-Analysis
  • Systematic Review

MeSH terms

  • COVID-19 / drug therapy*
  • COVID-19 / virology*
  • Humans
  • Hydroxychloroquine / administration & dosage
  • Hydroxychloroquine / adverse effects
  • Hydroxychloroquine / therapeutic use*
  • Odds Ratio
  • Randomized Controlled Trials as Topic
  • SARS-CoV-2 / drug effects*
  • Treatment Outcome


  • Hydroxychloroquine

Supplementary concepts

  • COVID-19 drug treatment