An interventional study of Blood sample in COVID-19 and Cystic Fibrosis, sponsored by Hospices Civils de Lyon. Completed at 19 sites in France. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Other
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
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 331 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
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Exclusion Criteria:
For France
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
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)
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.
Time frame: 2 years
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.
Time frame: 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
Time frame: 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
Time frame: 10 years maximum
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon