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Completed
NCT05629923
EVALUATION OF DIFFERENT PROPHYLACTIC INTERVENTIONS TOWARD COVID-19 IN SOLID ORGAN TRANSPLANT PATIENTS
Conditions: COVID-19 Pandemic, Transplant-Related Disorder
Sex: All
Ages: 18 Years – 99 Years
Enrollment: 306
Sponsor: University of Rome Tor Vergata
Location: Italy
Summary
The goal of this observational study is to evaluate the immune response after COVID-19 vaccination in Liver(LT) and Kidney(KT) transplant recipient.
The main question it aims to answer are:the evaluation of the antibody response after complete vaccinationthe efficacy of prophylaxis with long-acting-antibody prophylaxis (LAAB)All LT and KT patients during follow-up have been enrolled.
anti-COVID-19 title was obtained by Electrochemiluminescence Immunoassay (ECLIA) Test(Elyx, Roche).
In the case of antibody level <100 IU/ml, patients were invited to prophylaxis with tixagevimab-cilgavimab(AZD7442, AstraZeneca).
At three months, a follow-up was performed to assess any COVID-19 infection.
At Six months another anti-COVID-19 title is obtained by ECLIA Test(Elyx, Roche) in LT and KT who undergo to LAAB.
Eligibility Criteria
Inclusion Criteria:KT and LT transplant patients in follow up in Tor Vergata UniversityAge >18 yearsAt least 3 month post transplantationExclusion Criteria:pediatric recipientsActive covid infection at the time of the studyPregnancyAllergy to any ingredients included in the vaccineAcute liver or kidney acute rejection proven by biopsyAcute Febrile state with either leucopenia or leucocytosisHigh dose of corticosteroid at study timing (pulse methyl prednisolone)
Source: ClinicalTrials.gov (NCT05629923). StuddyBuddy aggregates publicly available trial information.