A new European clinical trial is recruiting adults and children with cystic fibrosis (CF) to prospectively determine the proportion who have SARS-CoV-2 antibodies over a 2-year period.
The study will also assess the differences in the clinical presentation of patients with CF and SARS-CoV-2 antibodies and the effect of the antibodies on their disease.
The prospective, longitudinal cohort study is currently recruiting up to 1000 patients with CF of any age and genotype from CF centers in Europe who will be followed for 24 months. Participants will provide blood samples at months 6, 12, 18, and 24 as part of their routine clinical visits and additionally as needed.
As well as the blood samples, patient data on demographics, medical history, exacerbations, sputum microbiology, and lung function will be recorded. The primary outcome measures are (1) SARS-CoV-2 prevalence changes in serum over time, (2) the impact of seropositivity on symptoms and outcomes of patients with CF, and (3) a comparison of antibodies in patients with CF after infection vs after vaccination.
Read more about CF comorbidities
CF is a hereditary (autosomal recessive), progressive condition that causes a thickening of exocrine gland secretions. Patients experience an accumulation of abnormally thick mucus in the lungs, sweat glands, gastrointestinal tract, pancreas, and other organs, and this accumulation can lead to inflammation, infection, blocked airways, and respiratory failure. CF is caused by genetic mutations in the CF transmembrane conductance regulator protein.
The research team is particularly interested in the effect of SARS-CoV-2 infection on clinical outcomes of patients with CF and specific patient subgroups. The aim is to determine whether there are age- or sex-related differences, as well as any differences in outcomes in patients who have had lung transplantation or those who are undergoing CF transmembrane conductance regulator modulator therapies.
The study began recruitment on August 22, 2022, and is expected to be completed on September 1, 2025.
COVID-19 Antibody Responses in Cystic Fibrosis. (CAR-CF). ClinicalTrials.gov. September 20, 2022. Accessed November 7, 2022.