单克隆抗体（mAb）已获得2019年轻中度冠状病毒病（COVID-19）或预防COVID-19的紧急使用授权，包括卡西利维单抗加imdevimab（C+I），bamlanivimab加etesevimab（B+E），tixagevimab加西加维玛（T+CG），和sotrovimab（S）和bebtelovimab（BEB）。进行系统评价是为了评估其有效性和安全性。PubMed,Embase,Scopus,medRxiv,bioRxiv,本研究检索了2021年1月至2022年5月期间发表的研究和FDA情况说明书,并使用与上述mAb相关的适当检索词进行数据收集.审查包括原创性研究，包括随机临床试验和发表或预印本的观察性研究。该综述中包括的研究与安慰剂或标准护理或无治疗或单克隆抗体之间以及各种剂量进行了比较。进行了数据提取，并对有效性和安全性进行了审查。本综述共纳入20项研究。与安慰剂组的7%相比，30天内的住院率为2%。用组合mAb更观察到病毒载量的显著降低。联合疗法显示出针对Gamma变体的更快的病毒学治愈。用C+I作为暴露后预防（PEP），29.0%的无症状参与者出现有症状的COVID-19。使用T+CG的暴露前预防使感染的发生率降低了77%。输液相关反应是最常见的不良事件（AE）。中和的mAb减少了轻度至中度患者的住院率，这些患者的输液相关反应是常见的AE。血清阴性患者的反应更好。大多数这些研究是在未接种疫苗的个体中进行的，并且针对Alpha，Gamma,和Delta变体。
Monoclonal antibodies (mAbs) had received emergency use authorization for mild-to-moderate coronavirus disease 2019 (COVID-19) or for prophylaxis against COVID-19, including casirivimab plus imdevimab (C+I), bamlanivimab plus etesevimab (B+E), tixagevimab plus cilgavimab (T+CG), and sotrovimab (S) and bebtelovimab (BEB). This systematic
review was done to assess the efficacy and safety of the same. PubMed, Embase, Scopus, medRxiv, bioRxiv, and FDA fact sheets were searched for the studies published between January 2021 and May 2022, and appropriate search terms related to the mentioned mAbs were used for data collection.
Review included original research including randomized clinical trials and observational studies published or preprints. Studies included in the
review had compared with placebo or standard of care or no treatment or mAbs with each other and also of various doses. Data extraction was done and reviewed the same for both efficacy and safety. Total of 20 studies were included in this
review. The rate of hospitalization within 30 days showed ∼2% in comparison to ∼7% with placebo. Significant reduction in viral load was more observed with combination mAbs. Combination therapy showed faster virological cure against the Gamma variant. With C + I as postexposure prophylaxis (PEP), 29.0% of asymptomatic participants developed symptomatic COVID-19. Pre-exposure prophylaxis with T+CG reduced the incidence of infection by 77%. Infusion-related reaction was the most common adverse event (AE). The neutralizing mAbs reduced hospitalization in mild-to-moderate patients with infusion-related reactions as common AE. The response was better in the seronegative patients. Most of these studies were conducted in unvaccinated individuals and against Alpha, Gamma, and Delta variants.
