COVID-19 Antibody Responses in Cystic Fibrosis

NCT05561868 | Unknown DMC

• 1 other identifier: 026
• Study Type: observational
• Target: 70
• 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. 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.

Conditions

Cystic Fibrosis; COVID-19

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)

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

• Children's Health Ireland: lead
• European Cystic Fibrosis Society: collaborator
• Cystic Fibrosis Foundation: collaborator
• Queen's University, Belfast: collaborator

Study Sites (2)

Children's Health Ireland at Tallaght

Tallaght, Dublin, D24 TN3C, Ireland

Location

Children's Health Ireland at Crumlin

Dublin, D12 N512, Ireland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood serum samples will be collected for analysis of COVID-19 antibody levels.

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 Design

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

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: September 30, 2022
• Study Start: August 22, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (2)