Back to resultsTransplantation of Deceased Donors With COVID-19 Into COVID-19 Negative Recipients Utilizing Casirivimab and Imdevimab Antibody Cocktail
Primary Purpose
COVID-19, Organ Transplant
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Casirivimab and Imdevimab Antibody Cocktail
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring Regeneron, Covid-19 Antibodies
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Northwell Health Organ Transplant Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Casirivimab and Imdevimab Antibody Cocktail
Arm Description
Patients receiving a Covid-19 positive liver, kidney, or heart transplant.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Patient and graft survival at 30 days, 6 months and 1 year
Assess patient and graft survival at 30 days
Adverse effects of casirivimab with imdevimab (REGEN-COV) antibody cocktail
Assessment of adverse effects of casirivimab with imdevimab
Stored serum will be evaluated when feasible for SARS-CoV-2 RNA
Biopsy proven rejection at 30 days
Full Information
NCT ID
NCT05157997
First Posted
December 13, 2021
Last Updated
April 14, 2022
Sponsor
Northwell Health
Collaborators
Regeneron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT05157997
Brief Title
Transplantation of Deceased Donors With COVID-19 Into COVID-19 Negative Recipients Utilizing Casirivimab and Imdevimab Antibody Cocktail
Official Title
Transplantation of Deceased Donors With COVID-19 Into COVID-19 Negative Recipients Utilizing Casirivimab and Imdevimab Antibody Cocktail
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
New information regarding COVID-19
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health
Collaborators
Regeneron Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Organ Transplant
Keywords
Regeneron, Covid-19 Antibodies
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Casirivimab and Imdevimab Antibody Cocktail
Arm Type
Experimental
Arm Description
Patients receiving a Covid-19 positive liver, kidney, or heart transplant.
Intervention Type
Drug
Intervention Name(s)
Casirivimab and Imdevimab Antibody Cocktail
Intervention Description
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.
Primary Outcome Measure Information:
Title
Monitoring for SARS-CoV-2 infection
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
30-day admission rate to hospital post-transplant due to COVID-19
Description
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
Time Frame
30 days
Title
Patient and graft survival at 30 days, 6 months and 1 year
Description
Assess patient and graft survival at 30 days
Time Frame
30 days, 6 months, and 1 year
Title
Adverse effects of casirivimab with imdevimab (REGEN-COV) antibody cocktail
Description
Assessment of adverse effects of casirivimab with imdevimab
Time Frame
1 year
Title
Stored serum will be evaluated when feasible for SARS-CoV-2 RNA
Description
Biopsy proven rejection at 30 days
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lewis Teperman, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwell Health Organ Transplant Center
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Transplantation of Deceased Donors With COVID-19 Into COVID-19 Negative Recipients Utilizing Casirivimab and Imdevimab Antibody Cocktail
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