COVID-19 Antibody Responses in Cystic Fibrosis

NCT05614336 | Completed

• 1 other identifier: 69HCL21_0478
• Study Type: interventional
• Target: 331
• Locations: 1 country
• Sites: 19

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

COVID-19; Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Association of SARS-CoV-2 seropositivity, clinical symptoms and clinical outcomes in pwCF

  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

  2 years

• Serum proteomic and genomic responses of pwCF who are SARS-CoV-2 seropositive an seronegative

  10 years maximum

Study Arms (1)

Cystic Fibrosis patients

OTHER

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

Interventions

Blood sample BIOLOGICAL

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)

Cystic Fibrosis patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Refusal to give informed consent
• Contraindication to venepuncture
• For France
• Person under guardianship / curatorship
• Person under legal protection

Sponsors & Collaborators

• Hospices Civils de Lyon: lead
• Queen's University, Belfast: collaborator

Study Sites (19)

C.R.C.M. Pédiatrique (Centre de Ressources et de Compétences en Mucoviscidose) Hôpital des Enfants-Pellegrin - CHU de Bordeaux

Bordeaux, 33076, France

Location

Pneumologie, allergologie et Mucoviscidose - CRCM Lyon pédiatrie Hôpital Femme Mère Enfant /Groupement Est

Bron, 69677, France

Location

Centre de Ressources et de Competences de la Mucoviscidose (Enfants) CHU Grenoble Alpes - Hôpital Couple Enfant

Grenoble, 38043, France

Location

Hôpital Albert Calmette - CHU de Lille

Lille, France

Location

Hôpital Jeanne de Flandre

Lille, France

Location

CHU Timone-Enfants - APHM

Marseille, France

Location

Service des maladies respiratoires Hôpital Arnaud de Villeneuve - CHU de Montpellier

Montpellier, 34295, France

Location

CHU de Nice

Nice, 06002, France

Location

Hôpitaux Pédiatriques de Nice CHU Lenval

Nice, 06200, France

Location

Hôpital Cochin, AP-HP

Paris, France

Location

Hôpital Necker Enfants Malades - APHP

Paris, France

Location

Hôpital Robert Debré - APHP

Paris, France

Location

Service de pédiatrie générale et spécialisée American Memorial Hospital - CHU de Reims

Reims, 51092, France

Location

Service de pneumologie - Centre cardio-pneumologie Hôpital Pontchaillou - CHU de Rennes

Rennes, 35033, France

Location

CRCM Pédiatrique Hôpital Sud - CHU de Rennes

Rennes, 35203, France

Location

Fondation Ildys

Roscoff, 29684, France

Location

Maladies respiratoires, allergologie - CRCM Mixte de Rouen Hôpital Charles Nicole - CHU de Rouen

Rouen, 76000, France

Location

Service de pneumo-allergologie pédiatrique CRCM pédiatrique CHU de Toulouse - Hôpital des Enfants

Toulouse, 31059, France

Location

Service Pneumologie-Allergologie CRCM adulte Hôpital Larrey - CHU de Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

COVID-19; Cystic Fibrosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 14, 2022
• Study Start: June 15, 2022
• Primary Completion: September 17, 2025
• Study Completion: September 17, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (19)