COVID-19 Antibody Responses in Cystic Fibrosis

NCT04992234 | Completed

• 1 other identifier: CAR-CF
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 2

Brief Summary

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. We will also examine the effects of SARS-CoV-2 infection on clinical outcomes and analyse end-points 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 we will perform 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.

Conditions

Cystic Fibrosis; Covid19

Keywords

Cystic Fibrosis; COVID-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (3)

• To evaluate SARS-CoV-2 seroprevalence

  To evaluate SARS-CoV-2 seroprevalence in a cohort of people with cystic fibrosis, followed longitudinally over a 3-year period

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

• To examine the associations

  To examine the associations between SARS-CoV-2 seropositivity, clinical symptoms and clinical outcomes in a cohort of people with cystic fibrosis

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

• To perform a longitudinal comparison

  To perform a longitudinal comparison of the development and progression of anti-SARS-CoV-2 antibodies in people with cystic fibrosis following natural infection and vaccination SARS-CoV-2

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

Secondary Outcomes (1)

• Storage of samples for future analysis

  anticipated 5-10 year

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 will be eligible to participate in the study. The study population is expected to be representative of the general CF population.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Karolinska Institutet: collaborator
• Queen's University, Belfast: collaborator
• European Cystic Fibrosis Society - Clinical Trials Network: collaborator
• Cystic Fibrosis Foundation: collaborator

Study Sites (2)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Karolinska University Hospital

Huddinge, Sweden

Location

Biospecimen

Retention: 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

Cystic Fibrosis; COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

• Marita Gilljam

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 5, 2021
• Study Start: August 31, 2021
• Primary Completion: July 22, 2024
• Study Completion: April 14, 2025
• Last Updated: January 30, 2026

Record last verified: 2025-09

Locations

SE (2)