NCT05074433终止3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies as Pre-Exposure Prophylaxis to Prevent COVID-19 in Immunocompromised Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 66
- 试验地点
- 53
- 主要终点
- Cumulative Incidence of Symptomatic (Broad Term), RT-PCR-confirmed SARS-CoV-2 Infection Cases During the EAP
研究概览
简要总结
The primary objective of the study is to evaluate the effect of casirivimab+imdevimab, compared with placebo, in preventing symptomatic SARS-CoV-2 infection in immunocompromised participants.
The secondary objectives of the study are:
- To evaluate the safety and tolerability of repeated SC injections of casirivimab+imdevimab in the study population
- To characterize concentrations of casirivimab and imdevimab in serum over time
- To assess the immunogenicity of casirivimab and imdevimab
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets ≥1 of the following criteria:
- •Is immunocompromised, including people with transplant, who have cancer, primary immunodeficiencies, HIV, rheumatological disease, autoimmune disease, multiple sclerosis OR
- •Currently taking immunosuppressant drugs
- •Have been fully vaccinated against COVID-19 or deemed medically ineligible to receive full course of vaccine
- •Has documented negative serology/antibody response in an anti-SARS-CoV-2 spike protein IgG clinical test or ≤50 U/mL on the Elecsys® SARS-CoV-2 S Total Ig test
- •Tested negative for the COVID-19 virus within 72 hours prior to randomization
排除标准
- •Weighs <40 kg (only applies to participants ≥12 to <18 years of age)
- •Has any signs or symptoms consistent with COVID-19
- •Past COVID-19 infection within 90 days prior to randomization
- •Planned use of any investigational, authorized, or approved vaccine for COVID-19 within 90 days of the last dose of study drug
- •Prior, current, or planned use of any of COVID-19 convalescent plasma, other monoclonal antibodies against SARS-CoV-2 or any COVID-19 treatment
- •Is planned to begin immunoglobulin (IVIG) or immunoglobulin (SCIG) therapy, is planned to have a change to existing IVIG or SCIG, or has been on a chronic stable dose of their IVIG or SCIG regimen for less than 90 days prior to screening
- •Has any known active acute respiratory infection
- •Has persistent (refractory to treatment for ≥14 days) bacterial or fungal infection
- •Has known allergy or hypersensitivity to components of the study drugs
- •NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply
研究组 & 干预措施
Placebo
Placebo Comparator
SC dose Q4W
干预措施: Placebo (Drug)
casirivimab+imdevimab Initial + Q4W
Experimental
Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W)
干预措施: casirivimab+imdevimab (Drug)
casirivimab+imdevimab Q4W
Experimental
SC dose Q4W
干预措施: casirivimab+imdevimab (Drug)
casirivimab+imdevimab Q12W
Experimental
SC dose every 12 weeks (Q12W)
干预措施: casirivimab+imdevimab (Drug)
结局指标
主要结局
Cumulative Incidence of Symptomatic (Broad Term), RT-PCR-confirmed SARS-CoV-2 Infection Cases During the EAP
时间窗: The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Cumulative incidence of symptomatic (broad term), RT-PCR-confirmed SARS-CoV-2 infection cases during the Efficacy Assessment Period (EAP)
次要结局
- Number of Participants With Grade ≥3 Treatment-emergent Adverse Events (TEAEs) During the Follow-Up Period(End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months))
- Concentration of Casirivimab Over Time(Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group)
- Number of Participants With Grade ≥3 Treatment-emergent Adverse Events (TEAEs) During the EAP(The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days)
- Concentration of Imdevimab Over Time(Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group)
- Incidence of Neutralizing Antibodies (NAb) to Each mAb Over Time(Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group)
- Number of Participants With TEAEs Leading to Study Drug Discontinuation During the Follow-Up Period(End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months))
- Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the EAP(The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days)
- Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Follow-Up Period(End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months))
- Number of Participants With TEAEs Leading to Study Drug Discontinuation During the EAP(The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days)
- Incidence of Adverse Events of Special Interest (AESIs) During the EAP(The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days)
- Incidence of Anti-drug Antibodies (ADA) Over Time(Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group)
研究者
研究点 (53)
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