Covid-19 Antibody Responses in Cystic Fibrosis

NCT05012306 | Active Not Recruiting

• 1 other identifier: V1.0_01-MAR-2021
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 8

Brief Summary

Coronavirus disease 2019 (COVID-19) which is caused by the virus Severe Acute Respiratory Syndrome Coronavirus-2 (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 investigators will also examine the effects of SARS-CoV-2 infection on clinical outcomes and analyse end-points to explore any age-related or gender-based differences, as well as subgroup analysis of outcomes in lung-transplant recipients and pwCF receiving cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies. As pwCF receive COVID-19 vaccination the investigators will perform 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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• To evaluate SARS-CoV-2 seroprevalence

  To evaluate SARS-CoV-2 seroprevalence in a cohort of people with cystic fibrosis, followed longitudinally over a 3-year period (comprising a 1-year enrollment period and a 2-year follow-up). \[ Time Frame: 3-year period (comprising a 1-year enrollment period and a 2-year follow-up) \] To examine the associations between SARS-CoV-2 seropositivity, clinical symptoms and clinical outcomes in a cohort of people with cystic fibrosis

  3-year period (comprising a 1-year enrollment period and a 2-year follow-up)

Secondary Outcomes (1)

• Storage of samples for future analysis

  anticipated 5-10 years

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

Participants already enrolled in a clinical trial are eligible for enrolment in this study. Inclusion in CAR-CF should not preclude enrolment in other observational clinical trial studies or clinical trials of an investigational medicinal product (CTIMP).

You may qualify if:

• 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.

Sponsors & Collaborators

• Universitätsklinikum Köln: lead

Study Sites (8)

Hannover Medical School, Clinic for Pediatric Pneumology, Allergology and Neonatology & Clinic for Pneumology, Hannover

Hanover, Lower Saxony, 30625, Germany

Location

University Children's Hospital Bochum, Paediatric Pneumology and CF Center

Bochum, 44791, Germany

Location

CF Center, University Hospital Cologne

Cologne, 50924, Germany

Location

Pediatric Pulmonology and Sleep Medicine, Cystic Fibrosis Center, Children's Hospital, University of Duisburg-Essen

Essen, 45147, Germany

Location

Ruhrlandklinik, Westdeutsches Lungenzentrum gGmbH

Essen, 45239, Germany

Location

Universitätsklinikum Frankfurt a.M., Allergologie, Pneumologie & Mukoviszidose

Frankfurt am Main, 60596, Germany

Location

University of Jena, Cystic Fibrosis Centre for children and adults

Jena, 07747, Germany

Location

Cystic Fibrosis Center for Adults, Department of Pneumology

München, 80336, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood serum

MeSH Terms

Conditions

Cystic Fibrosis

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

Study Officials

• Silke van Koningsbruggen-Rietschel, MD, PhD

  CF Center, University Hospital, University of Cologne, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 19, 2021
• Study Start: May 28, 2021
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8)