Diaz Jorge, Fonseca Allex, Yan Lixin, Liu Dongfang, Xie Liangzhi
Doral Medical Research, LLC, Florida, USA.
Cecor - Centro Oncologico de Roraima, Roraima, Brazil.
Contemp Clin Trials Commun. 2025 May 17;45:101496. doi: 10.1016/j.conctc.2025.101496. eCollection 2025 Jun.
BACKGROUND/OBJECTIVE: The neutralizing monoclonal antibody against SARS-CoV-2 is regarded as one of the most effective therapies for COVID-19. This study was a randomized, double-blinded, placebo-controlled Phase II trial conducted to evaluate the efficacy of neutralizing monoclonal antibody (SCTA01) in high-risk outpatients diagnosed with COVID-19.
The primary endpoint was the proportion of patients who experienced COVID-19-related hospitalization (defined as at least 24 h of acute care) or death (all causes) by Day 29.
109 patients were randomly assigned to and received SCTA01 750 mg (n = 25), 1500 mg (n = 29), 3000 mg (n = 30), or placebo (n = 25). Only two experienced COVID-19-related hospitalization by Day 29, one from the 750 mg group and the other from the 3000 mg group. Statistical analysis revealed no significant differences in viral load reduction ( = 0.20) or symptom score reduction ( = 0.37) between the SCTA01 total and placebo groups. Additionally, the incidence of adverse events was comparable between the SCTA01 group (23.8 %) and the placebo group (24.0 %). Notably, no treatment-related serious adverse events (SAEs) were reported.
There was no significant difference in clinical outcome between SCTA01 and placebo in the treatment of high-risk outpatients diagnosed with COVID-19, and it was well tolerated.
The trial was registered at ClinicalTrial.gov (NCT04709328).
背景/目的：抗SARS-CoV-2中和单克隆抗体被视为治疗COVID-19最有效的疗法之一。本研究是一项随机、双盲、安慰剂对照的II期试验，旨在评估中和单克隆抗体（SCTA01）对确诊为COVID-19的高危门诊患者的疗效。
主要终点是在第29天时发生COVID-19相关住院（定义为至少24小时的急性护理）或死亡（各种原因）的患者比例。
109例患者被随机分配并接受750毫克SCTA01（n = 25）、1500毫克（n = 29）、3000毫克（n = 30）或安慰剂（n = 25）。到第29天时，只有2例发生COVID-19相关住院，1例来自750毫克组，另1例来自3000毫克组。统计分析显示，SCTA01总体组和安慰剂组之间在病毒载量降低（= 0.20）或症状评分降低（= 0.37）方面无显著差异。此外，SCTA01组（23.8%）和安慰剂组（24.0%）的不良事件发生率相当。值得注意的是，未报告与治疗相关的严重不良事件（SAE）。
在治疗确诊为COVID-19的高危门诊患者时，SCTA01与安慰剂在临床结局上无显著差异，且耐受性良好。
该试验已在ClinicalTrial.gov（NCT04709328）注册。
