COVID-19 Antibody Responses In Cystic Fibrosis
CAR-CF
1 other identifier
observational
1,000
1 country
11
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 throughout the United Kingdom. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2021
Typical duration for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2021
CompletedFirst Posted
Study publicly available on registry
April 28, 2021
CompletedStudy Start
First participant enrolled
November 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedFebruary 1, 2022
January 1, 2022
2.4 years
April 27, 2021
January 17, 2022
Conditions
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
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Queen's University, Belfastlead
- Cystic Fibrosis Foundationcollaborator
Study Sites (11)
University Hospital Southampton Nhs Foundation Trust
Southampton, Engladn, SO16 6YD, United Kingdom
University Hospitals Birmingham Nhs Foundation Trust
Birmingham, England, B15 2GW, United Kingdom
Birmingham Women'S and Children'S Nhs Foundation Trust
Birmingham, England, B4 6NH, United Kingdom
Leeds Teaching Hospitals Nhs Trust
Leeds, England, LS9 7TF, United Kingdom
King'S College Hospital Nhs Foundation Trust
London, England, SE5 9RS, United Kingdom
Royal Brompton & Harefield Nhs Foundation Trust
London, England, SW3 6NP, United Kingdom
Nottingham University Hospitals Nhs Trust
Nottingham, England, NG7 2UH, United Kingdom
Queens University Belfast
Belfast, Northern Ireland, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, Scotland, G12 0XH, United Kingdom
Cardiff & Vale University Lhb
Cardiff, Wales, CF14 4HH, United Kingdom
Cardiff & Vale University Lhb
Cardiff, Wales, United Kingdom
Biospecimen
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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Damian Downey
Queens University Belfast
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Senior Lecturer
Study Record Dates
First Submitted
April 27, 2021
First Posted
April 28, 2021
Study Start
November 19, 2021
Primary Completion
May 1, 2024
Study Completion
May 1, 2024
Last Updated
February 1, 2022
Record last verified: 2022-01