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

NCT05157997 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 21-1223
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Organ Transplant

Keywords

Regeneron; Covid-19 Antibodies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 30-day admission rate to hospital post-transplant due to COVID-19

  30 days

• Patient and graft survival at 30 days, 6 months and 1 year

  30 days, 6 months, and 1 year

• Adverse effects of casirivimab with imdevimab (REGEN-COV) antibody cocktail

  1 year

• Stored serum will be evaluated when feasible for SARS-CoV-2 RNA

  30 days

Study Arms (1)

Casirivimab and Imdevimab Antibody Cocktail

EXPERIMENTAL

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

Drug: Casirivimab and Imdevimab Antibody Cocktail

Interventions

Casirivimab and Imdevimab Antibody Cocktail 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.

Casirivimab and Imdevimab Antibody Cocktail

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject provides written informed consent prior to initiation of any study procedures.
• Understands and agrees to comply with planned study procedures.
• Adult ≥18 years of age at time of enrollment, pediatric ages will be excluded.
• 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
• Subject is confirmed COVID-19 negative confirmed by PCR at time of transplant with no signs and symptoms consistent with COVID-19
• 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

You may not qualify if:

• Any exposure to investigational medications targeting COVID-19
• Previous use of casirivimab with imdevimab antibody cocktail (REGEN-COV)
• Previous treatment of COVID-19 with a monoclonal antibody
• Active COVID-19 infection
• Allergy to casirivimab with imdevimab
• Pregnant patients
• Prior transplant
• Hepatitis C virus/NCT positive deceased donors

Sponsors & Collaborators

• Northwell Health: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Northwell Health Organ Transplant Center

Manhasset, New York, 11030, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

casirivimab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lewis Teperman, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: December 15, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 22, 2022

Record last verified: 2022-04

Locations

US (1)