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Trial - EUCTR2021-003277-55-AT


Column Value
Trial registration number EUCTR2021-003277-55-AT
Full text link
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-003277-55/AT

First author
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

Medical University of Innsbruck, Paediatrics Department, Cystic Fibrosis Center - Ass. Prof. Dr. Helmut Elemunter

Contact
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

CFCI-Studies@i-med.ac.at

Registration date
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

2021-07-27

Recruitment status
Last imported at : Feb. 1, 2025, 8 a.m.
Source : EU Clinical Trials Register

Completed

Study design
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

nonRCT

Allocation
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

Non-randomized

Design
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

Parallel

Masking
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

Open label

Center
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

multi-center

Study aim
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

Prevention

Inclusion criteria
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

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.

Exclusion criteria
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

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

Number of arms
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

4

Funding
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

Medical University of Innsbruck, University Clinic for Pediatrics III

Inclusion age min
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

0

Inclusion age max
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

100

Countries
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

Canada;European Union;Ireland;United Kingdom;United States;Austria

Type of patients
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

High risk patients

Severity scale
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

N/A

Total sample size
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

200

primary outcome
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

Potential endpoint(s) to include to investigate objective • Proportion of pwCF with at least 1 seropositive result over the 2-year period • Seroprevalence according to age group • Seroprevalence according to geographical area • Seroprevalence according to CF disease genotype and severity. • Change in seroprevalence over time • Risk factors for infection in pwCF • Incidence of symptomatic COVID-19 over the 2 year study period and symptom severity • Proportion of seropositive pwCF with subsequent CF exacerbations compared to pwCF who are seronegative • Morbidity and mortality in pwCF with at least 1 seropositive result compared to pwCF who are seronegative • Levels and duration of anti-SARS-CoV-2 antibodies in pwCF following natural infection and vaccination SARS-CoV-2 • Analysis of these samples could include proteomic and genetic analysis and relating this to clinical outcome and antibody data collected as part of main study.

Notes
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

nan

Phase
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

Phase 4

Arms
Last imported at : Sept. 3, 2021, 1 a.m.
Source : EU Clinical Trials Register

[{"arm_notes": "", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]