Transplantation of Deceased Donors With COVID-19 Into COVID-19 Negative Recipients Utilizing Casirivimab and Imdevimab Antibody Cocktail
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Monitoring for SARS-CoV-2 infection
研究概览
简要总结
This study will look to increase the donor pool for the solid organ transplant population by transplanting patients who died with COVID-19 but not from COVID-19 utilizing casirivimab and imdevimab antibody cocktail to prevent the transmission of the virus.
详细描述
This is single-center, proof of concept study that is expected to last up to three months. The target enrollment for this study is 14 subjects ≥18 years of age with a need of a kidney, liver or heart. This study will investigate the effects of the investigational product during a four-week intervention phase followed by a 12-month observation phase. Study population will be derived from patients in Northwell Health Transplant Center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Subject provides written informed consent prior to initiation of any study procedures.
- •Understands and agrees to comply with planned study procedures.
- •Adult ≥18 years of age at time of enrollment, pediatric ages will be excluded.
- •Subject consents to receiving a COVID-19 positive organ (kidney, liver, or heart)
- •a. Deceased immunocompetent donor with positive SARS-CoV-2 RT-PCR testing from the respiratory tract (upper or lower): i. Within 21 days since the date of COVID-19 diagnosis OR ii. Within 90 days since the date of COVID-19 diagnosis
- •Subject is confirmed COVID-19 negative confirmed by PCR at time of transplant with no signs and symptoms consistent with COVID-19
- •All candidates must be fully vaccinated 2 weeks prior to enrollment a. When applicable candidates can receive a booster vaccine as defined by the FDA/CDC
排除标准
- •Any exposure to investigational medications targeting COVID-19
- •Previous use of casirivimab with imdevimab antibody cocktail (REGEN-COV)
- •Previous treatment of COVID-19 with a monoclonal antibody
- •Active COVID-19 infection
- •Allergy to casirivimab with imdevimab
- •Pregnant patients
- •Prior transplant
- •Hepatitis C virus/NCT positive deceased donors
研究组 & 干预措施
Casirivimab and Imdevimab Antibody Cocktail
Patients receiving a Covid-19 positive liver, kidney, or heart transplant.
干预措施: Casirivimab and Imdevimab Antibody Cocktail (Drug)
结局指标
主要结局
Monitoring for SARS-CoV-2 infection
时间窗: 30 days
The overall objective of the study is to have transplant COVID-19 positive organs into COVID-19 negative recipients with no transmission of the virus. This will be assessed by monitoring for SARS-CoV-2 infection at different time points post-transplantation.
次要结局
- 30-day admission rate to hospital post-transplant due to COVID-19(30 days)
- Adverse effects of casirivimab with imdevimab (REGEN-COV) antibody cocktail(1 year)
- Stored serum will be evaluated when feasible for SARS-CoV-2 RNA(30 days)
- Patient and graft survival at 30 days, 6 months and 1 year(30 days, 6 months, and 1 year)