Transplantation of Deceased Donors With COVID-19 Into COVID-19 Negative Recipients Utilizing Casirivimab and Imdevimab Antibody Cocktail

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Transplantation of Deceased Donors With COVID-19 Into COVID-19 Negative Recipients Utilizing Casirivimab and Imdevimab Antibody Cocktail

Conditions
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COVID-19, Organ Transplant

Intervention / Treatment
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* Drug: Casirivimab and Imdevimab Antibody Cocktail


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Casirivimab and Imdevimab Antibody Cocktail<br>Patients receiving a Covid-19 positive liver, kidney, or heart transplant. | Drug: Casirivimab and Imdevimab Antibody Cocktail<br>* The study will utilize REGEN-COV 8,000mg (4,000 mg of each monoclonal antibody) given as IV infusion on day of transplant and 2400mg (1,200 mg of each monoclonal antibody) on post-operative day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitoring for SARS-CoV-2 infection | 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day admission rate to hospital post-transplant due to COVID-19 | No 30-day readmission to the hospital due to COVID-19. All patients re-admitted to the hospital will be tested for COVID-19 by nasopharyngeal swab | 30 days | 
| Patient and graft survival at 30 days, 6 months and 1 year | Assess patient and graft survival at 30 days | 30 days, 6 months, and 1 year | 
| Adverse effects of casirivimab with imdevimab (REGEN-COV) antibody cocktail | Assessment of adverse effects of casirivimab with imdevimab | 1 year | 
| Stored serum will be evaluated when feasible for SARS-CoV-2 RNA | Biopsy proven rejection at 30 days | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regeneron, Covid-19 Antibodies