NCT05074680Completed
COVID-19 Antibody Responses In Cystic Fibrosis
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
Coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 has resulted in an ongoing global pandemic. It is unclear whether the relatively low number of reported cases of COVID-19 in people with CF (pwCF) is due to enhanced infection prevention practices or whether pwCF have protective genetic/immune factors. This study aims to prospectively assess the proportion of pwCF, including both adults and children with CF who have evidence of SARS-CoV-2 antibodies over a two-year period. This study will also examine whether pwCF who have antibodies for SARS-CoV-2 have a different clinical presentation and what impact this has on their CF disease. The proposed study will recruit pwCF from paediatric and adult CF centres in Europe. Serological testing to detect antibodies will be performed on blood samples taken at month 0, 6, 12, 18 and 24 with additional time-points if bloodwork is available via normal clinical care. Clinical data on lung function, CF-related medical history, pulmonary exacerbations, antibiotic use, and microbiology and vaccination receipt, will be collected during routine clinical assessments. Associations will be examined between socio-demographic and clinical variables and serologic testing. The effects of SARS-CoV-2 infection on clinical outcomes and analyse end-points will be examined to explore any age-related or gender-based differences, as well as subgroup analysis of outcomes in lung-transplant recipients and pwCF receiving CFTR modulator therapies. As pwCF receive COVID-19 vaccination a comparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCF following natural infection and vaccination SARS-CoV-2 over time will be performed.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 5 (actual)
- First submitted
- 8 Jul 2021
- Start date
- 14 Feb 2022
- Primary completion date
- 29 May 2026
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Diseases
- Cystic fibrosis
- NCT number
- NCT05074680
What you commit to
- Study type: Observational
- Participants enrolled: 5
- From 14 Feb 2022 to the primary completion date, 29 May 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Refusal to give informed consent
- Contraindication to venepuncture. Participants already enrolled in a clinical trial are eligible for enrollment in this study. Inclusion in CAR-CF should not preclude enrollment in other observational clinical trial studies or clinical trials of an investigational medicinal product (CTIMP).
Who the study is looking for
- Consenting people (signed informed consent by participant or parent/caregiver in case of children \<14 years) with cystic fibrosis of any age, genotype, transplant status and disease severity
Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Children's Hospital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| University Children's Hospital Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.