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

• Sponsor: Northwell Health (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT05157997
• Collaborator: Regeneron Pharmaceuticals (Industry)
• Enrollment: 0
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19; Organ Transplant	Drug: Casirivimab and Imdevimab Antibody Cocktail	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Transplantation of Deceased Donors With COVID-19 Into COVID-19 Negative Recipients Utilizing Casirivimab and Imdevimab Antibody Cocktail
• Anticipated Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Casirivimab and Imdevimab Antibody Cocktail Patients receiving a Covid-19 positive liver, kidney, or heart transplant.	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.

Outcome Measures

Primary Outcome Measures

1. Monitoring for SARS-CoV-2 infection [30 days]

   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.

Secondary Outcome Measures

1. 30-day admission rate to hospital post-transplant due to COVID-19 [30 days]

   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

2. Patient and graft survival at 30 days, 6 months and 1 year [30 days, 6 months, and 1 year]

   Assess patient and graft survival at 30 days

3. Adverse effects of casirivimab with imdevimab (REGEN-COV) antibody cocktail [1 year]

   Assessment of adverse effects of casirivimab with imdevimab

4. Stored serum will be evaluated when feasible for SARS-CoV-2 RNA [30 days]

   Biopsy proven rejection at 30 days

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

1. 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

1. Subject is confirmed COVID-19 negative confirmed by PCR at time of transplant with no signs and symptoms consistent with COVID-19

2. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwell Health Organ Transplant Center	Manhasset	New York	United States	11030

Sponsors and Collaborators

• Northwell Health
• Regeneron Pharmaceuticals

Investigators

• Principal Investigator: Lewis Teperman, MD, Northwell Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Northwell Health
• ClinicalTrials.gov Identifier: NCT05157997
• Other Study ID Numbers: 21-1223
• First Posted: Dec 15, 2021
• Last Update Posted: Apr 22, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Northwell Health: Regeneron; Covid-19 Antibodies
• Additional relevant MeSH terms: COVID-19; Antibodies

Study Results

No Results Posted as of Apr 22, 2022