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

Phase 1

Withdrawn

• Conditions: Organ Transplant; COVID-19
• Interventions: Drug: Casirivimab and Imdevimab Antibody Cocktail

• Registration Number: NCT05157997
• Lead Sponsor: Northwell Health

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.

Study Timeline

• Study First Submitted: 2021-12-13
• Study First Submitted QC: 2021-12-13
• Study First Posted: 2021-12-15
• Study Start: 2022-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-14
• Last Update Posted: 2022-04-22
• Primary Completion: 2024-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Casirivimab and Imdevimab Antibody Cocktail	Casirivimab and Imdevimab Antibody Cocktail	Patients receiving a Covid-19 positive liver, kidney, or heart transplant.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Adverse effects of casirivimab with imdevimab (REGEN-COV) antibody cocktail	1 year	Assessment of adverse effects of casirivimab with imdevimab
Stored serum will be evaluated when feasible for SARS-CoV-2 RNA	30 days	Biopsy proven rejection at 30 days
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

Trial Locations

Locations (1)

Northwell Health Organ Transplant Center; 🇺🇸 Manhasset, New York, United States