COVID-19 Antibody Responses In Cystic Fibrosis

NCT05074680 | Active Not Recruiting DMC

• 1 other identifier: 2021-01137
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; SARS-CoV-2; COVID-19

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

  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.

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

Secondary Outcomes (1)

• Serum proteomic and genomic responses

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

Interventions

Blood sampling DIAGNOSTIC_TEST

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)

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

Consenting people (signed informed consent by participant or parent/caregiver in case of children \<14 years) 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 (signed informed consent by participant or parent/caregiver in case of children \<14 years) with cystic fibrosis of any age, genotype, transplant status and disease severity

You may not qualify if:

• Refusal to give informed consent

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• European Cystic Fibrosis Society: collaborator
• Cystic Fibrosis Foundation: collaborator

Study Sites (2)

University Children's hospital Bern

Bern, 3010, Switzerland

Location

University Children's hospital, Zürich

Zurich, 8032, Switzerland

Location

Related Links

• ECFS-CTN study overview
• Study description in German

Biospecimen

Retention: SAMPLES WITH DNA

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

Cystic Fibrosis; COVID-19

Interventions

Blood Specimen Collection

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; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Reta Fischer Biner, MD

  Quartier Bleu, Lindenhofspital Bern Site PI

  PRINCIPAL INVESTIGATOR

• Alexander Moeller, Prof

  University Children's Hospital Zurich Site PI

  PRINCIPAL INVESTIGATOR

• Carolin Steinack, MD

  University Hospital Zurich Site PI

  PRINCIPAL INVESTIGATOR

• Philipp Latzin, Prof

  Switzerland Country PI, University Hospital Bern Site PI

  PRINCIPAL INVESTIGATOR

• Damian Downey, MD

  Queen's University, Belfast

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: October 12, 2021
• Study Start: February 14, 2022
• Primary Completion: December 31, 2023
• Study Completion: July 31, 2025
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

CH (2)