Status:
WITHDRAWN
TIXAGEVIMAB/CILGAVIMAB Protection of Covid-19 in Transplanted Patients
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Solid Organ Transplant Recipients
Eligibility:
All Genders
18+ years
Brief Summary
Covid-19 has a very bad prognosis in solid organ transplant recipients with a 60 days-mortality exceeding 20%. For this reason, transplant patients were prioritized to receive Covid-19 vaccination sin...
Eligibility Criteria
Inclusion
- Male or female, 18 years of age or older
- Recipient of a solid organ transplant
- Subject affiliated with a health insurance company
- Patient able to understand the objectives and risks of the research and to give a non-objection
- Patient with a post-vaccination anti-Spike IgG (or RBD - Receptor Blinding Domain) titer of less than 30 BAU/ml ( (binding antibody units) measured at least 14 days after completion of an intensified vaccination regimen (at least 3 doses of mRNA vaccine) and prior to administration of anti-SARS-Cov-2 monoclonal antibodies.
- Group 1 criteria: Naïve patients, never having received anti-SARS CoV2 monoclonal antibodies.
- Group 2 criteria: Patients who have previously received anti-SARS Cov2 monoclonal antibodies
Exclusion
- History of anaphylactic shock or known allergy to TIXAGEVIMAB/CILGAVIMAB
- Known history of Covid-19 or positive Covid-19 serology within 3 months prior to inclusion
- History of myocardial infarction or coronary artery disease within 3 months prior to inclusion
- Contraindication to an intramuscular injection
- Impossibility to give to the subject an informed information
- Subject under legal protection, guardianship or curatorship
- Plasmapheresis in progress or planned
- Weight less than 48 kg
- Patient participating in another interventional research study in progress
- Pregnant, parturient, or breastfeeding women
Key Trial Info
Start Date :
February 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05234398
Start Date
February 1 2022
End Date
August 1 2023
Last Update
September 1 2022
Active Locations (2)
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1
Service de Néphrologie, Transplantation et Immunologie Clinique Hôpital Edouard Herriot - Hospices Civils de Lyon
Lyon, France, 69437
2
Service de Néphrologie et Transplantation, Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091