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

NCT ID: NCT05157997

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2025-01-31

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.

Conditions

COVID-19; Organ Transplant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Casirivimab and Imdevimab Antibody Cocktail

Patients receiving a Covid-19 positive liver, kidney, or heart transplant.

Group Type: EXPERIMENTAL

Casirivimab and Imdevimab Antibody Cocktail

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lewis Teperman, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Northwell Health Organ Transplant Center

Manhasset, New York, United States

Countries

United States

Other Identifiers

21-1223

Identifier Type: -

Identifier Source: org_study_id