Clinical trial NCT05157997: 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
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: COVID-19
Organ Transplant
Keywords: Regeneron
Covid-19 Antibodies
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2021-12-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Monitoring for SARS-CoV-2 infection
timeFrame: 30 days
Secondary outcomes:
measure: 30-day admission rate to hospital post-transplant due to COVID-19
timeFrame: 30 days
measure: Patient and graft survival at 30 days, 6 months and 1 year
timeFrame: 30 days, 6 months, and 1 year
measure: Adverse effects of casirivimab with imdevimab (REGEN-COV) antibody cocktail
timeFrame: 1 year
measure: Stored serum will be evaluated when feasible for SARS-CoV-2 RNA
timeFrame: 30 days
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Northwell Health Organ Transplant Center
state: New York
Study officials:
affiliation: Northwell Health
name: Lewis Teperman, MD
role: PRINCIPAL_INVESTIGATOR
References: