J Med Virol. 2022 Jan 27. doi: 10.1002/jmv.27623. Online ahead of print.
OBJECTIVE: To assess the clinical efficacy and safety of neutralizing monoclonal antibodies (mABs) for outpatients with COVID-19.
METHODS: PubMed, Embase, Web of Science, Cochrane Library, ClinicalTrials.gov and WHO ICTRP databases were searched from inception to July 19, 2021. Only randomized controlled trials (RCTs) that assessed the clinical efficacy and safety of neutralizing mAbs in the treatment of COVID-19 outpatients were included. The Cochrane risk-of-bias tool was used to assess the quality of the included RCTs. The primary outcome was the risk of COVID-19-related hospitalization or emergency department (ED) visits. The secondary outcomes were the risk of death and adverse events (AEs).
RESULTS: Five articles were included, in which 3,309 patients who received neutralizing mAb and 2,397 patients who received placebo. A significantly lower rate of hospitalization or ED visits was observed among patients who received neutralizing mAbs than those who received a placebo (1.7% versus 6.5%, OR, 0.26; 95% CI, 0.19-0.36; I2 = 0%). In addition, the rate of hospitalization was significantly lower in the patients who received neutralizing mABs than in the control group (OR, 0.24; 95% CI, 0.17-0.34; I2 = 0%). The mortality rate was also significantly lower in the patients who received neutralizing mABs than in the control group (OR, 0.16; 95% CI, 0.05-0.58; I2 = 3%). Neutralizing mABs were associated with a similar risk of any AE (OR 0.81, 95% CI 0.64-1.01, I2 = 52%) and a lower risk of serious AEs (OR 0.37, 97% CI 0.19-0.72, I2 = 45%) compared with a placebo.
CONCLUSIONS: Neutralizing mABs can help reduce the risk of hospitalization or ED visits in COVID-19 outpatients. For these patients, neutralizing mABs are safe and not associated with a higher risk of AEs than a placebo. This article is protected by copyright. All rights reserved.