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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05157997
• Other study ID #: 21-1223
• Status: Withdrawn
• Phase: Phase 1
• Start date: January 2022
• Est. completion date: January 2025

Study information

• Verified date: April 2022
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2025
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Organ Transplant

Intervention

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.

Locations

Country	Name	City	State
United States	Northwell Health Organ Transplant Center	Manhasset	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days
Secondary	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	30 days
Secondary	Patient and graft survival at 30 days, 6 months and 1 year	Assess patient and graft survival at 30 days	30 days, 6 months, and 1 year
Secondary	Adverse effects of casirivimab with imdevimab (REGEN-COV) antibody cocktail	Assessment of adverse effects of casirivimab with imdevimab	1 year
Secondary	Stored serum will be evaluated when feasible for SARS-CoV-2 RNA	Biopsy proven rejection at 30 days	30 days