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Clinical trial

Evaluation of the Immune Response to COVID-19 Vaccine in Recipients of Living Donor Liver Transplantation

ID
Name
RHDIRB2020110301 REC 45
Description
A prospective cohort study to evaluate the response to COVID-19 vaccine in liver transplantation patients.
Trial arms
Trial start
2021-09-15
Estimated PCD
2023-06-30
Trial end
2023-11-30
Status
Recruiting
Treatment
COVID-19 Vaccine
Severe acute respiratory syndrome- coronavirus-2 (SARS-CoV-2)vaccine according to vaccine availability in the Egyptian ministry of health.
Arms:
Vaccinated group
Size
50
Primary endpoint
Neutralizing antibody titer change 14 days after vaccination compared to baseline
At baseline, at 14 days after whole course of vaccination
Neutralizing antibody titer change 28 days post vaccination compared to baseline
At baseline and 28 days after whole course of vaccination
Eligibility criteria
Inclusion Criteria: * Age\>18 * At least 3 month post transplantation Exclusion Criteria: * pediatric recipients * Active covid infection at the time of the study * Pregnancy * Allergy to any ingredients included in the vaccine * Lactation in first six month of delivery * Active Acute cellular rejection proven by liver biopsy * Acute Febrile state with either leucopenia or leucocytosis * High dose of corticosteroid at study timing (pulse methyl prednisolone)
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2023-02-14

1 organization

1 product

1 indication

Organization
Ain Shams University
Product
COVID-19 Vaccine
Indication
Liver Transplant