NCT05156645撤回1 期
An Adaptive Phase I/II/III Trial to Evaluate the Efficacy and Safety of Anti-SARS-CoV-2 Monoclonal Antibody Combination (SCTA01C and SCTA01) for Treatment of Outpatients With COVID-19
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Proportion of participants who experience COVID-19 related hospitalization (defined as at least 24 hours of acute care) or death (all cause) up to Day 29 (Phase III)
研究概览
简要总结
The study is comprised of two parts: safety evaluation part (Phase I/II) and the pivotal study (Phase III) to evaluate the efficacy and safety of the combination of SCTA01 & SCTA01C compared to placebo in addition to Standard of Care (SOC).
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
- •Male or non-pregnant female adults, ≥18 years old of age at the time of randomization;
- •Participants should have at least one of COVID-19 risk factor;
- •Participants should have at least 2 COVID-19 related symptoms;
- •Has symptoms consistent with COVID-19 as determined by the investigator with onset ≤10 days before randomization;
- •First positive SARS-CoV-2 viral infection tested (PCR or antigen-based diagnostic tests) in samples collected ≤5 days prior to start of the infusion;
排除标准
- •Participants with a history of severe anaphylaxis, such as severe anaphylactic reaction, urticaria, and angioedema;
- •Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300, respiratory rate ≥30 per minute, heart rate ≥125 per minute (FDA);
- •Require mechanical ventilation or anticipated impending need for mechanical ventilation;
- •Suspected or proven serious bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking part in this study;
- •Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study;
研究组 & 干预措施
SCTA01 and SCTA01C+SOC
Experimental
干预措施: SCTA01 and SCTA01C (Drug)
Placebo+SOC
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of participants who experience COVID-19 related hospitalization (defined as at least 24 hours of acute care) or death (all cause) up to Day 29 (Phase III)
时间窗: Day 29
Proportion of patients with ≥Grade 3 treatment related adverse event (TRAE) up to Day 8 (Phase I/II)
时间窗: Day 8
次要结局
- Time to sustained resolution of all COVID-19-related symptoms(Day 29)
- Change in symptom score (total of ratings)(Day 3, 5, 7, 11, 15, 22, and 29)
- Proportion of participants that achieve SARS-CoV-2 clearance in NP or OP samples(Day 29)
- Immunogenicity assessment includes the number and percentage of patients who develop detectable anti drug antibody(Day 120)
- Time to symptom improvement(Day 29)
- Mean concentration-time profiles of SCTA01 and SCTA01C(Day 120)
研究者
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