Mazzotta Valentina, Lepri Alessandro Cozzi, Del Borgo Cosmo, Lanini Simone, Meschi Silvia, Garattini Silvia, Rosati Silvia, Siciliano Valentina, Vergori Alessandra, Coppola Luigi, Falletta Antonio, Carraro Anna, Gramigna Giulia, Oliva Alessandra, Matteini Elena, Gasperin Andrea, Giannico Giuseppina, Mastrorosa Ilaria, Matusali Giulia, D'Abramo Alessandra, Marocco Raffaella, Milozzi Eugenia, Cerva Carlotta, Gavaruzzi Francesca, Rueca Martina, Cimaglia Claudia, Piselli Pierluca, Fantoni Massimo, Girardi Enrico, Sarmati Loredana, Mastroianni Claudio M, Andreoni Massimo, Torti Carlo, Nicastri Emanuele, Maggi Fabrizio, Lichtner Miriam, Antinori Andrea
Clinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy.
Centre for Clinical Research, Epidemiology, Modelling and Evaluation (CREME), Institute for Global Health, UCL, London, UK.
J Med Virol. 2025 May;97(5):e70379. doi: 10.1002/jmv.70379.
Studies comparing all available strategies for the early treatment of mild-to-moderate COVID-19 during the Omicron era are lacking. We included people with mild-to-moderate COVID-19 and at high risk of progressing to severe disease attending five outpatient clinics in Italy over 2022-2023. The primary outcome was the proportion of participants who experienced Day-30 hospitalization due to COVID-19 or death. Participants received either nirmatrelvir/ritonavir (NMV/r), molnupiravir (MLP), remdesivir (RDV), sotrovimab (SOT), or tixagevimab/cilgavimab (TIX/CIL). We included 10 038 individuals: females 5052 (50%), median age 71 years (IQR 59-81). In total, 1919 (19%) received SOT, 3732 (37.2%) MLP, 1444 (14%) RDV, 2510 (25%) NMV/r, and 433 (4%) TIX/CIL. Only 1689 (17%) had incomplete vaccination, and 2435 (24.3%) were not immunocompetent. The rate of hospitalization/death was 2.40% (95% CI 2.10-2.71). Unadjusted rates were 0.88% (95% CI 0.55-1.32) for NMV/r, 1.69% (95% CI 1.30-2.15) for MLP, 3.0% (95% CI 1.61-5.08) for TIX/CIL, 3.54% (95% CI 2.76-4.47) for SOT and 5.12% (95% CI 4.05-6.39) for RDV. Weighted analysis showed that NMV/r and MLP were superior to all other interventions. In our population of individuals at high risk of progression to severe disease, there was clinical benefit in using NMV/r or MLP instead of mAbs-based therapies or RDV.
缺乏在奥密克戎时代比较所有可用的轻至中度新冠肺炎早期治疗策略的研究。我们纳入了2022年至2023年期间在意大利五家门诊就诊的轻至中度新冠肺炎患者，这些患者有进展为重症疾病的高风险。主要结局是因新冠肺炎或死亡而在第30天住院的参与者比例。参与者接受了奈玛特韦/利托那韦（NMV/r）、莫努匹拉韦（MLP）、瑞德西韦（RDV）、索托维单抗（SOT）或替沙格韦单抗/西加韦单抗（TIX/CIL）治疗。我们纳入了10038名个体：女性5052名（50%），年龄中位数71岁（四分位间距59 - 81岁）。总计，1919名（19%）接受了SOT，3732名（37.2%）接受了MLP，1444名（14%）接受了RDV，2510名（25%）接受了NMV/r，433名（4%）接受了TIX/CIL。只有1689名（17%）接种疫苗不完全，2435名（24.3%）无免疫能力。住院/死亡率为2.40%（95%置信区间2.10 - 2.71）。未经调整的比率分别为：NMV/r为0.88%（95%置信区间0.55 - 1.32），MLP为1.69%（95%置信区间1.30 - 2.15），TIX/CIL为3.0%（95%置信区间1.61 - 5.08），SOT为3.54%（95%置信区间2.76 - 4.47），RDV为5.12%（95%置信区间4.05 - 6.39）。加权分析表明，NMV/r和MLP优于所有其他干预措施。在我们这个有进展为重症疾病高风险的个体群体中，使用NMV/r或MLP而非基于单克隆抗体的疗法或RDV有临床益处。
