Efficacy and safety of SARS-CoV-2 neutralizing antibody, SCTA01, in high-risk outpatients diagnosed with COVID-19: A Phase II clinical trial

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-05-17 DOI:10.1016/j.conctc.2025.101496

Jorge Diaz , Allex Fonseca , Lixin Yan , Dongfang Liu , Liangzhi Xie

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引用次数: 0

Abstract

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.

Methods

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.

Results

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 (p = 0.20) or symptom score reduction (p = 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.

Conclusions

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.

CLINICAL TRIAL

The trial was registered at ClinicalTrial.gov (NCT04709328).

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SARS-CoV-2中和抗体SCTA01在门诊诊断为COVID-19的高危患者中的疗效和安全性：一项II期临床试验

背景/目的SARS-CoV-2中和性单克隆抗体被认为是治疗COVID-19最有效的方法之一。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COVID-19门诊高危患者的疗效。方法主要终点是在第29天发生与covid -19相关的住院（定义为至少24小时的急性护理）或死亡（所有原因）的患者比例。109例患者被随机分配并接受SCTA01 750 mg （n = 25）、1500 mg （n = 29）、3000 mg （n = 30）或安慰剂（n = 25）治疗。到第29天，只有两人因covid -19相关住院，其中一人来自750毫克组，另一人来自3000毫克组。统计分析显示，SCTA01总剂量组与安慰剂组在病毒载量降低（p = 0.20）或症状评分降低（p = 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，没有报道与治疗相关的严重不良事件（SAEs）。结论SCTA01与安慰剂治疗新冠肺炎门诊高危患者临床转归无显著差异，且耐受性良好。临床试验该试验已在ClinicalTrial.gov注册（NCT04709328）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.