Is hydroxychloroquine safety for COVID-19? a systematic review and
meta-analysis of randomized trials
Abstract
Aim: Many concerns still existed about the safety of hydroxychloroquine
(HCQ) in the treatment of Corona Virus Disease 2019 (COVID-19). The
purpose of this study was to evaluate the safety of HCQ by performing a
systematic review and meta-analysis. Methods: Randomized controlled
trials reporting the safety of HCQ in PubMed, Embase, and Cochrane
Library were retrieved from the establishment of the database to
February 27, 2020. Literature screening, data extraction, and assessment
of risk bias were performed independently by two reviewers. Results: We
identified 34 eligible studies that involved 3,639 patients. The
difference in the cumulative number of AEs between the HCQ and control
group was statistically significant (P<0.0001). The pooled
incidence of gastrointestinal AEs, which occurred most frequently in the
HCQ group was higher than that in the control group (P<0.0001)
according to the system organ class. In addition, the risks of skin and
subcutaneous tissue AEs (P = 0.011), renal and urinary disorders
(P=0.011), ear and labyrinth AEs (P = 0.045) and surgical and medical
procedures AEs (P = 0.020) in HCQ group are also significantly increased
compared with the control group. Meanwhile, the cumulative number of
SAEs was similar between the two groups (P=0.222). Meta-analysis results
indicated that the pooled incidences of all the AEs reported by two or
more studies were similar except for the treatment discontinuation
caused by AEs (RD 0.02, 95% CI: 0.00 to 0.06). Conclusion: HCQ was well
tolerated and might be safe for clinical application under the outbreak
of COVID-19.