COVID-19, Organ Transplant
Conditions
Keywords
Regeneron, Covid-19 Antibodies
Brief summary
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
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.
Interventions
DRUGCasirivimab and Imdevimab Antibody Cocktail
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.
Sponsors
Regeneron Pharmaceuticals
Northwell Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject provides written informed consent prior to initiation of any study procedures. 2. Understands and agrees to comply with planned study procedures. 3. Adult ≥18 years of age at time of enrollment, pediatric ages will be excluded. 4. 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 5. Subject is confirmed COVID-19 negative confirmed by PCR at time of transplant with no signs and symptoms consistent with COVID-19 6. 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
1. Any exposure to investigational medications targeting COVID-19 2. Previous use of casirivimab with imdevimab antibody cocktail (REGEN-COV) 3. Previous treatment of COVID-19 with a monoclonal antibody 4. Active COVID-19 infection 5. Allergy to casirivimab with imdevimab 6. Pregnant patients 7. Prior transplant 8. Hepatitis C virus/NCT positive deceased donors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monitoring for SARS-CoV-2 infection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day admission rate to hospital post-transplant due to COVID-19 | 30 days | 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 |
| Patient and graft survival at 30 days, 6 months and 1 year | 30 days, 6 months, and 1 year | Assess patient and graft survival at 30 days |
| Adverse effects of casirivimab with imdevimab (REGEN-COV) antibody cocktail | 1 year | Assessment of adverse effects of casirivimab with imdevimab |
| Stored serum will be evaluated when feasible for SARS-CoV-2 RNA | 30 days | Biopsy proven rejection at 30 days |
Countries
United States
Outcome results
None listed