COVID-19 Antibody Responses in Cystic Fibrosis: CAR-CF

Phase 1

• Conditions: COVID-19 vaccine Antibody response from natural infection or after vaccination in patients with Cystic Fibrosis (CF); MedDRA version: 20.0Level: LLTClassification code 10021433Term: ImmunizationSystem Organ Class: 100000004865; MedDRA version: 20.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2021-003277-55-AT
• Lead Sponsor: Medical University of Innsbruck, University Clinic for Pediatrics III

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-27
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Consenting people with CF (pwCF) of any age, genotype, transplant status and disease severity will be eligible to participate in the study. The study population is expected to be representative of the general CF population.
Are the trial subjects under 18? yes
Number of subjects for this age range: 2450
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2525
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

There are no specific exclusion criteria other than refusal to give informed consent, or contraindication to venipuncture.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified