COVID-19 Antibody Responses in Cystic Fibrosis

Study Overview
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Brief Summary
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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

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

Conditions
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COVID-19, Cystic Fibrosis

Intervention / Treatment
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* Biological: Blood sample


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cystic Fibrosis patients<br>Patients with cystic fibrosis, regardless of age, genetic profile, transplant status and disease severity will be eligible to participate in the study. | Biological: Blood sample<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 2 years | 
| Serum proteomic and genomic responses of pwCF who are SARS-CoV-2 seropositive an seronegative | Serum proteomic and genomic responses of pwCF who are SARS-CoV-2 seropositive an seronegative | 10 years maximum |