Safety and efficacy of hydroxychloroquine as prophylactic against COVID-19 in healthcare workers: a meta-analysis of randomised clinical trials

BMJ Open. 2023 Jun 16;13(6):e065305. doi: 10.1136/bmjopen-2022-065305.

Abstract

Objective: We studied the safety and efficacy of hydroxychloroquine (HCQ) as pre-exposure prophylaxis for COVID-19 in healthcare workers (HCWs), using a meta-analysis of randomised controlled trials (RCTs).

Data sources: PubMed and EMBASE databases were searched to identify randomised trials studying HCQ.

Study selection: Ten RCTs were identified (n=5079 participants).

Data extraction and synthesis: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were used in this systematic review and meta-analysis between HCQ and placebo using a Bayesian random-effects model. A pre-hoc statistical analysis plan was written.

Main outcomes: The primary efficacy outcome was PCR-confirmed SARS-CoV-2 infection and the primary safety outcome was incidence of adverse events. The secondary outcome included clinically suspected SARS-CoV-2 infection.

Results: Compared with placebo, HCWs randomised to HCQ had no significant difference in PCR-confirmed SARS-CoV-2 infection (OR 0.92, 95% credible interval (CI): 0.58, 1.37) or clinically suspected SARS-CoV-2 infection (OR 0.78, 95% CI: 0.57, 1.10), but significant difference in adverse events (OR 1.35, 95% CI: 1.03, 1.73).

Conclusions and relevance: Our meta-analysis of 10 RCTs investigating the safety and efficacy of HCQ as pre-exposure prophylaxis in HCWs found that compared with placebo, HCQ does not significantly reduce the risk of confirmed or clinically suspected SARS-CoV-2 infection, while HCQ significantly increases adverse events.

Prospero registration number: CRD42021285093.

Keywords: COVID-19; epidemiology; statistics & research methods.

Publication types

  • Systematic Review
  • Meta-Analysis
  • Research Support, Non-U.S. Gov't

MeSH terms

  • COVID-19 Drug Treatment
  • COVID-19* / prevention & control
  • Health Personnel
  • Humans
  • Hydroxychloroquine / adverse effects
  • Hydroxychloroquine / pharmacology
  • Pre-Exposure Prophylaxis
  • SARS-CoV-2

Substances

  • Hydroxychloroquine