NCT05157997

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19
• Organ Transplant

Interventions

Type	Name	Description
DRUG	Casirivimab 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.

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-01-01
• Completion: 2025-01-01
• First posted: 2021-12-15
• Last updated: 2022-04-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study