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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
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.
Northwell Health Organ Transplant Center
Manhasset, New York, United States
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.
Time frame: 30 days
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
Time frame: 30 days
Patient and graft survival at 30 days, 6 months and 1 year
Assess patient and graft survival at 30 days
Time frame: 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
Time frame: 1 year
Stored serum will be evaluated when feasible for SARS-CoV-2 RNA
Biopsy proven rejection at 30 days
Time frame: 30 days
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