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

NCT05745948 | Completed

• 1 other identifier: PR(AMI)381/2021
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The 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 has 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 sociodemographic and clinical variables and serologic testing. The effects of SARS-CoV-2 infection on clinical outcomes and analyze end-points will be examined to explore any age-related or gender-based differences, as well as a 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.

Conditions

COVID-19; Cystic Fibrosis

Outcome Measures

Primary Outcomes (3)

• SARS-COV-2 seroprevalence

  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.

  3-year period (comprising a 1-year enrollment period and a 2-year follow-up)

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

  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.

  3-year period (comprising a 1-year enrollment period and a 2-year follow-up)

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

  Measuring detectable antibody levels for each study participant at baseline and at each study time point including 6,12, 18 and 24 months post enrollment with additional samples if participant has blood drawn for other clinical care reason

  3-year period (comprising a 1-year enrollment period and a 2-year follow-up)

Secondary Outcomes (1)

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

  anticipated 5-10 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consenting people with cystic fibrosis 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.

You may qualify if:

• Consenting people with cystic fibrosis of any age, genotype, transplant status and disease severity

You may not qualify if:

• Refusal to give informed consent
• Contraindication to venepuncture

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Queen's University, Belfast: collaborator
• European Cystic Fibrosis Society - Clinical Trials Network: collaborator
• Cystic Fibrosis Foundation: collaborator
• Hospital Vall d'Hebron: collaborator

Study Sites (1)

Hospital Universitari Vall d'Hebron. Cystic Fibrosis Unit

Barcelona, Barcelona, 08035, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples With DNA 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)

MeSH Terms

Conditions

COVID-19; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Silvia Gartner, MD

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: February 27, 2023
• Study Start: January 24, 2023
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)