NCT06039449已完成3 期
A Study to Evaluate the Efficacy and Safety of VYD222 for Prevention of COVID-19 (CANOPY)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 790
- 试验地点
- 1
- 主要终点
- Cohort A - Incidence of treatment emergent adverse events
研究概览
简要总结
A study to investigate the prevention of COVID-19 with VYD222 in adults with immune compromise and in participants aged 12 years or older who are at risk of exposure to SARS-CoV-2
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Only applies to Cohort B
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
- •Is an adult aged ≥18 years or an adolescent aged 12 to <18 years and weighs at least 40 kg at the time of Screening.
- •Tests negative for current SARS-CoV-2 infection by local antigen test or RT-PCR at the time of Screening.
- •For Cohort A, has significant immune compromise from causes including solid tumor or hematologic malignancies, chimeric antigen receptor (CAR)-T-cell therapy or hematopoietic stem cell transplant, primary immunodeficiency, advanced HIV infection, or receiving qualifying immunosuppressive therapies.
- •For Cohort B, is at risk of acquiring SARS-CoV-2 due to regular unmasked face-to-face interactions in indoor settings.
- •Agrees to defer receipt of any COVID-19 vaccination or booster for a minimum of 28 days after dosing.
- •Note: unless specified by Cohort, the criteria apply to both Cohorts
排除标准
- •For Cohort B: Prior receipt of a COVID-19 vaccine or booster within 120 days before randomization.
- •Prior receipt of convalescent plasma or a mAb to SARS-CoV-2 active against currently circulating variants, including in the setting of a clinical trial, within 120 days before randomization.
- •Prior known or suspected SARS-CoV-2 infection within 120 days before randomization.
- •Exposure to someone with known or suspected SARS-CoV-2 infection in the 5 days before randomization.
- •Is acutely ill or has any symptoms suggestive of infection, in the opinion of the Investigator.
- •Note 1: Other protocol defined inclusion/exclusion criteria apply Note 2: Unless specified by Cohort, the criteria apply to both Cohorts
研究组 & 干预措施
Cohort A VYD222
Experimental
干预措施: VYD222 (pemivibart) (Drug)
Cohort B VYD222
Experimental
干预措施: VYD222 (pemivibart) (Drug)
Cohort B Placebo
Placebo Comparator
干预措施: Normal saline (Drug)
结局指标
主要结局
Cohort A - Incidence of treatment emergent adverse events
时间窗: Through Month 12
Cohort A - Ratio of SARS-CoV-2 sVNA titer against a relevant variant following VYD222 administration at Day 28 compared to a prespecified SARS-CoV-2 sVNA titer threshold.
时间窗: Day 28
Cohort B - Incidence of treatment emergent adverse events
时间窗: Through Month 12
次要结局
- Cohort A - sVNA titer by timepoint following VYD222 administration(Through Month 12)
- Cohort A - ADAs against VYD222(Through Month 12)
- Cohort B - ADAs against VYD222(Through Month 12)
- Cohort A - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration at Day 28 above a prespecified SARS-CoV-2 sVNA titer threshold.(Day 28)
- Cohort B - sVNA titer by timepoint following VYD222 administration(Through Month 12)
- Cohort A - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration above a minimum SARS-CoV-2 sVNA threshold by timepoint(Through Month 12)
- Cohort A - Serum concentrations (PK) of VYD222(Through Month 12)
- Cohort A - Proportion of participants with RT-PCR-confirmed symptomatic COVID-19(Through Month 12)
- Cohort B - Ratio of SARS-CoV-2 sVNA titer against a relevant variant following VYD222 administration at Day 28 compared to a prespecified SARS-CoV-2 sVNA titer threshold.(Day 28)
- Cohort B - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration at Day 28 above a prespecified SARS-CoV-2 sVNA titer threshold.(Day 28)
- Cohort B - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration above a minimum SARS-CoV-2 sVNA threshold by timepoint(Through Month 12)
- Cohort B - COVID-19-related hospitalization or COVID-19-related death within 28 days of symptom onset(Through Month 12)
- Cohort B - COVID-19-related death(Through Month 12)
- Cohort B - Serum concentrations (PK) of VYD222(Through Month 12)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
3 期
AZD1222 Vaccine for the Prevention of COVID-19COVID-19NCT04540393AstraZeneca
已完成
不适用
A Study to Investigate the Safety, Immunogenicity of Bivalent mRNA Vaccine RQ3027 and RQ3025 as a Booster Dose in Healthy AdultsCOVID-19NCT05907044Affiliated Hospital of Yunnan University376
已完成
1 期
Safety and Immunogenicity Study of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy AdultsSARS-CoV-2NCT04715997Genexine, Inc.185
终止
1 期
Safety and Immunogenicity Study of GX-19, a COVID-19 Preventive DNA Vaccine in Healthy AdultsSARS-CoV-2NCT04445389Genexine, Inc.60
已完成
2 期
Phase II / III Study of COVID-19 DNA Vaccine (AG0302-COVID19)COVID-19NCT04655625AnGes, Inc.500