A Multicenter, Adaptive, Randomized, Double-blinded, Placebo-controlled Phase II/III Trial to Evaluate the Efficacy and Safety of Monoclonal Antibody SCTA01 Against SARS-CoV-2 in Hospitalized Patients With Severe COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Time to Clinical Improvement up to Day 29
研究概览
简要总结
The study is a multicenter, adaptive, randomized, double-blinded and placebo-controlled Phase II/III trial, and will be conducted globally. The study is comprised of two parts: dose selection (Phase II) and pivotal treatment effect (Phase III).
详细描述
In this study, Phase II part will evaluate the efficacy, safety and PK of SCTA01 low dose+BSC, high dose+BSC and placebo+BSC in patients with severe COVID-19.
In Phase II part, subjects will be randomized at 1:1:1 ratio. At the end of Phase II part, a dose for the Phase III will be determined.
The Phase III part will evaluate the efficacy, safety, and immunogenicity of SCTA01 at the recommended dose recommended. Subjects in Phase III part will be randomized at 1:1 ratio to SCTA01+BSC and placebo+BSC groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients with severe COVID-19 (5 point on NIH 8-point ordinal scale).
- •Male or female adult ≥18 years of age at time of enrollment;
- •Biological samples (not limited to any specific type) collected within 72 hours before randomization is laboratory-confirmed as SARS-CoV-2 infection (PCR or antigen-based diagnostic tests);
- •≤ 10 days since symptoms of COVID-19 onset.
排除标准
- •Patients who need non-invasive ventilation or high flow oxygen (i.e., 6 point on the 8-point ordinal scale);
- •Patients with critical COVID-19;
- •Patients with Severe COVID-19 who received convalescent plasma or COVID-19 vaccine, or anti-SARS-CoV-2 spike (S) protein targeted therapy;
- •Alanine-amino transferase (ALT) or aspartate transaminase (AST) is 5 times higher than the upper limit of the normal value;
- •Estimated glomerular filtration rate (eGFR) <30 mL/min or on dialysis {eGFR calculated by Cockcroft-Gault formula (Cockcroft DW, 1976), Male: CrCL (mL/min) = [(140 - age) × weight (kg)] × 1/ [SCr (mg/dL) × 72]; Female: CrCL (mL/min) = [(140 - age) × weight (kg)] × 0.85/ [SCr (mg/dL) × 72]}.
研究组 & 干预措施
SCTA01 Low Dose+BSC
SCTA01in a lower dose+best supportive care
干预措施: SCTA01 (Drug)
SCTA01 High Dose+BSC
SCTA01in a higher dose+best supportive care
干预措施: SCTA01 (Drug)
Placebo+BSC
SCTA01 excipients+best supportive care
干预措施: Placebo (Other)
结局指标
主要结局
Time to Clinical Improvement up to Day 29
时间窗: Day 29
The median time to clinical improvement in the SCTA01 groups and control group
次要结局
未报告次要终点