Miljanovic, Danijela (57403944300)Danijela (57403944300)MiljanovicCirkovic, Andja (56120460600)Andja (56120460600)CirkovicLazarevic, Ivana (23485928400)Ivana (23485928400)LazarevicKnezevic, Aleksandra (22034890600)Aleksandra (22034890600)KnezevicCupic, Maja (15730255400)Maja (15730255400)CupicBanko, Ana (35774145100)Ana (35774145100)Banko2025-06-122025-06-122023https://doi.org/10.1002/rmv.2439https://www.scopus.com/inward/record.uri?eid=2-s2.0-85150871613&doi=10.1002%2frmv.2439&partnerID=40&md5=36c6b1a490d171a2c9d22bff1c26124bhttps://remedy.med.bg.ac.rs/handle/123456789/2695Until now, the treatment protocols for COVID-19 have been revised multiple times. The use and approval of therapeutic monoclonal antibodies (mAbs) for COVID-19 treatment represent exceptional achievements in modern science, technology and medicine. SARS-CoV-2 Omicron evasion of pre-existing immunity represents a serious public health problem nowadays. This systematic review with meta-analysis provided comprehensive and up-to-date evidence of the clinical efficacy of therapeutic anti-SARS-CoV-2 mAbs against Omicron subvariants in COVID-19 patients and included 10 articles. The prevalence of hospitalisation among Omicron-positive patients treated with anti-SARS-CoV-2 mAbs was 2.8% (89/3169) while it controls (Omicron-positive patients treated with other therapies) 11% (154/1371). There was a statistically significantly different number of hospitalisations between the two studied groups in favour of the anti-SARS-CoV-2 mAbs treated group. (OR = 0.56, 95% CI OR = 0.41–0.77, p < 0.001, respectively). Eight deaths (0.30%) out of 2619 Omicron-positive patients occurred in the anti-SARS-CoV-2 mAbs treated group, while in the control group (Omicron-positive patients treated with other therapies), 27 patients died out of 1401 (1.93%). There was a significantly different number of deaths between the two studied groups in favour of Omicron-positive patients treated with anti-SARS-CoV-2 mAbs (OR = 0.38, 95% CI OR = 0.17–0.85, p = 0.020). Using sotrovimab in treating Omicron-positive patients indicated a reduction of hospitalisation and mortality for 49% and 89% in favour of sotrovimab, respectively (OR = 0.51, 95% CI OR = 0.34–0.79, p = 0.002; OR = 0.11, 95% CI OR = 0.03–0.39, p = 0.001). We could only provide evidence of the positive impact in reducing hospitalisation and mortality rates when anti-SARS-CoV-2 mAbs were used to treat patients infected with Omicron variants BA.1 or BA.2 and not on other Omicron variants. © 2023 John Wiley & Sons Ltd.clinical outcomesCOVID-19efficacymonoclonal antibodiesOmicronSARS-CoV-2