COVID-19 Antibody Responses in Cystic Fibrosis (CAR-CF)

Civil Hospices of Lyon

Status: Active, not recruiting

Conditions: COVID-19; Cystic Fibrosis

Treatments: Biological: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT05614336

69HCL21_0478

Details and patient eligibility

About

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

Enrollment: 331 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Person with cystic fibrosis of any age, genotype, transplant status and disease severity.
• Express consent obtained after informing the patient and/or his legal representatives or parents In France, written and informed consent will be requested.
• For France, affiliation to a social security scheme or similar

Exclusion criteria

• Refusal to give informed consent

• Contraindication to venepuncture

• For France

  • Person under guardianship / curatorship
  • Person under legal protection

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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331 participants in 1 patient group

Cystic Fibrosis patients

Other group

Description:

Patients with cystic fibrosis, regardless of age, genetic profile, transplant status and disease severity will be eligible to participate in the study.

Treatment:

Biological: Blood sample