COVID-19Phase 1NCT05157997
Transplantation of Deceased Donors With COVID-19 Into COVID-19 Negative Recipients Utilizing Casirivimab and Imdevimab Antibody Cocktail
A Phase 1 study testing Casirivimab and Imdevimab Antibody Cocktail in people with COVID-19 and Organ Transplant, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Organ Transplant
- What is being tested?
- Casirivimab and Imdevimab Antibody Cocktail
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2022to Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwell Health Organ Transplant Center
Manhasset, New York, 11030
About this study
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.
Read the 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.
- Conditions
- COVID-19, Organ Transplant
- Being tested
- Casirivimab and Imdevimab Antibody Cocktail
- Keywords
- Regeneron, Covid-19 Antibodies
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Casirivimab and Imdevimab Antibody CocktailDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Casirivimab and Imdevimab Antibody Cocktail | Experimental | Patients receiving a Covid-19 positive liver, kidney, or heart transplant. Receives: Drug: Casirivimab and Imdevimab Antibody Cocktail |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (4)
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
Measured: 30 days
Patient and graft survival at 30 days, 6 months and 1 year
Assess patient and graft survival at 30 days
Measured: 30 days, 6 months, and 1 year
Adverse effects of casirivimab with imdevimab (REGEN-COV) antibody cocktail
Assessment of adverse effects of casirivimab with imdevimab
Measured: 1 year
Stored serum will be evaluated when feasible for SARS-CoV-2 RNA
Biopsy proven rejection at 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study startJan 2022 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJan 2025 (estimated)
Why it stopped: New information regarding COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Lewis Teperman, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157997
- Sponsor's protocol ID
- 21-1223
- Status last verified
- Apr 2022
- First submitted
- 13 Dec 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplantation of Deceased Donors With COVID-19 Into COVID-19 Negative Recipients Utilizing Casirivimab and Imdevimab Antibody Cocktail
- ClinicalTrials.gov ID
- NCT05157997
- Acronym / sponsor ID
- 21-1223
- Conditions
- COVID-19, Organ Transplant
- Keywords
- Regeneron, Covid-19 Antibodies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: New information regarding COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Casirivimab and Imdevimab Antibody Cocktail | Experimental | Drug: Casirivimab and Imdevimab Antibody CocktailPatients receiving a Covid-19 positive liver, kidney, or heart transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
- Subject is confirmed COVID-19 negative confirmed by PCR at time of transplant with no signs and symptoms consistent with COVID-19
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Casirivimab and Imdevimab Antibody CocktailThe 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. | Drug | Casirivimab and Imdevimab Antibody Cocktail |
Primary outcome
Monitoring for SARS-CoV-2 infection
Time frame: 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.
4 secondary outcomes
30-day admission rate to hospital post-transplant due to COVID-19
Time frame: 30 days
Patient and graft survival at 30 days, 6 months and 1 year
Time frame: 30 days, 6 months, and 1 year
Adverse effects of casirivimab with imdevimab (REGEN-COV) antibody cocktail
Time frame: 1 year
Stored serum will be evaluated when feasible for SARS-CoV-2 RNA
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lewis Teperman, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Casirivimab and Imdevimab Antibody Cocktail in people with COVID-19 and Organ Transplant, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitoring for SARS-CoV-2 infection (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.