NCT04709328尚未招募2 期
An Adaptive, Randomized, Double-blinded, Placebo-controlled Phase II/III Trial of Monoclonal Antibody SCTA01 Against SARS-CoV-2 in High-Risk Outpatients With COVID-19 (MAOP3 Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 690
- 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.
研究概览
简要总结
The study is a multicenter, adaptive, randomized, double-blinded and placebo-controlled Phase II/III clinical trial. It will be conducted at selected investigational sites globally. The study is comprised of 2 parts.
详细描述
The study is a multicenter, adaptive, randomized, double-blinded, and placebocontrolled Phase II/III trial. It will be conducted globally. The study will evaluate the efficacy and safety of SCTA01 in high-risk outpatients with COVID-19.The primary objective of the study is to evaluate the clinical efficacy rate among study group [SCTA01+ standard of care (SOC)] and control group (placebo + SOC) up to Day 29.
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
- Triple (Participant, Care Provider, Investigator)
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 ≤7 days before randomization;
- •First positive SARS-CoV-2 viral infection tested (PCR or antigen-based diagnostic tests) in samples collected ≤3 days prior to start of the infusion;
- •Participants are currently not hospitalized;
- •Participant (or legal authorized representative) has signed the ICF before any clinical activity related to SCTA01 trial;
- •Women with childbearing potential must agree to use effective contraceptive methods during the study period;
- •Patient should not participate in other clinical studies related to COVID-19 or SARS-CoV-2 infection.
排除标准
- •Have known allergies to any of the components used in the formulation of the SCTA01/placebo;
- •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;
- •Have any co-morbidity requiring surgery within <29 days, or that is considered life threatening within 29 days;
- •Have a history of previous SARS-CoV-2 infection;
- •Received convalescent plasma, COVID-19 vaccine, or anti-SARS-CoV-2 spike(S) protein targeted therapy;
- •Have participated in a clinical study involving an investigational intervention within past 30 days or 5-half lives of investigational product, whichever is longer;
- •Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing;
- •Pregnant or lactating women;
- •Anticipated hospitalization or transfer to another medical site which is not a study site within 72 hours;
- •Participants unable to follow the protocol during the study;
- •Participants deemed inappropriate for enrollment by the investigator due to other factors.
研究组 & 干预措施
SCTA01 low dose +SOC
Experimental
SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
干预措施: SCTA01 (Drug)
SCTA01 middle dose+SOC
Experimental
SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
干预措施: SCTA01 (Drug)
SCTA01 High dose +SOC
Experimental
SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
干预措施: SCTA01 (Drug)
Placebo+SOC
Placebo Comparator
SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
干预措施: Placebo (Other)
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.
时间窗: Day 29
次要结局
- Proportion of participants with ventilation requirements(Day 29)
- Cumulative incidence of serious adverse events (SAEs)(Day 120)
- Proportion of participants with ≥1 ER visit due to COVID-19(Day 29)
- Proportion of participants with ≥2 ER visits due to COVID-19 through Day 29(Day 29)
- Proportion of participants admitted to an intensive care unit (ICU) due to COVID-19(Day 29)
- Proportion of participants with O2 requirement(Day 29)
- Time to symptom improvement;(Day 29)
- Proportion of participants with ≥1 COVID-19 related hospitalization(Day 29)
- Proportion of participants who experience COVID-19 related emergency room (ER) visit(Day 29)
- Proportion of patients with all-cause mortality(Day 29)
- Discontinuation or temporary suspension of infusions (for any reason)(Day 120)
- Incidence and titers (if applicable) of anti-drug antibodies (ADA) to SCTA01(Day 1, Day 8, Day 29, and Day 120))
- 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 admitted to hospital due to COVID-19(Day 29)
- Proportion of participants with ≥2 COVID-19 related hospitalizations(Day 29)
- Total number of COVID-19 related hospitalization(Day 29)
- Proportion of participants that achieve SARS-CoV-2 clearance in nasopharyngeal (NP) or oropharyngeal (OP) samples(Day 8, Day 15)
- Cumulative incidence of Grade 1, 2, 3 and 4 adverse events (AEs)(Day 120)
- Number and proportion of patients with ADE(Day 120)
- Change from baseline (Day 1) to Day 8 or Day 15 in SARS-CoV-2 viral shedding as measured by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in NP or OP samples for SARS-CoV-2 test.(Day 8, Day 15)
- Mean concentration-time profiles of SCTA01(Day 29)
研究者
相似试验
终止
2 期
The Efficacy and Safety of SCTA01 in Hospitalized Patients With Severe COVID-19Covid19NCT04644185Sinocelltech Ltd.102
Unknown
2 期
The Safety and Efficacy of SCTA01 Against COVID-19 in Patients Admitted to High Dependence or Intensive CareCovid19NCT04683328Sinocelltech Ltd.560
进行中（未招募）
2 期
Phosphatase Inhibition by Intracoronary Gene Therapy in Subjects With Non-Ischemic NYHA Class III Heart FailureCongestive Heart FailureNCT05598333AskBio Inc150
已完成
2 期
Add Glucokinase Activator to Target A1cDiabetes Mellitus, Type 2NCT02405260vTv Therapeutics190
已完成
3 期
Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal WomenHypoactive Sexual Desire DisorderNCT00612742BioSante Pharmaceuticals3,656