Overview

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

Status:
Not yet recruiting

Trial end date:
2025-01-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Northwell Health

Collaborator:

Regeneron Pharmaceuticals

Treatments:

Antibodies

Criteria

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