Skip to main content
OpenTrials
Completed

NCT Number: NCT05614336

COVID-19 Antibody Responses in Cystic Fibrosis

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

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

C.R.C.M. Pédiatrique (Centre de Ressources et de Compétences en Mucoviscidose) Hôpital des Enfants-Pellegrin - CHU de Bordeaux, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Biological

Blood serum samples will be collected for analysis of COVID-19 antibody levels. For participants who consent to the optional study, a second blood sample will also be drawn into EDTA tubes (plasma)

Primary outcomes

  1. SARS-COV-2 seroprevalence

    Time frame: 2 years

    Proportion of pwCF with at least 1 seropositive result over the study period and the difference in this proportion by age, geographical area and over time.

Secondary outcomes

  1. Association of SARS-CoV-2 seropositivity, clinical symptoms and clinical outcomes in pwCF

    Time frame: 2 years

    Incidence of symptomatic COVID-19 over the study period and severity; proportion of seropositive pwCF with subsequent CF exacerbation compared to pwCF who are seronegative; death rate in pwCF with at least one seropositive result compared to pwCF who are seronegative.

  2. Longitudinal comparison of the detection including level and duration of anti-SARS-CoV-2 antibodies in pwCF following natural infection and SARS-CoV-2 vaccination

    Time frame: 2 years

    Longitudinal comparison of the detection including level and duration of anti-SARS-CoV-2 antibodies in pwCF following natural infection and SARS-CoV-2 vaccination

  3. Serum proteomic and genomic responses of pwCF who are SARS-CoV-2 seropositive an seronegative

    Time frame: 10 years maximum

    Serum proteomic and genomic responses of pwCF who are SARS-CoV-2 seropositive an seronegative

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Collaborators

  • Queen's University, Belfast

Registry information

Official study title

Corona-Virus-Disease 2019 (Covid-19) Antibody Responses in Cystic Fibrosis

Acronym: CAR-CF

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2022
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.