Official Title
Corona-Virus-Disease 2019 (Covid-19) Antibody Responses in Cystic Fibrosis
Brief Summary

Coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 has resultedin an ongoing global pandemic. It is unclear whether the relatively low number ofreported cases of COVID-19 in people with CF (pwCF) is due to enhanced infectionprevention practices or whether pwCF have protective genetic/immune factors. This studyaims to prospectively assess the proportion of pwCF, including both adults and childrenwith CF who have evidence of SARS-CoV-2 antibodies over a two-year period. This studywill also examine whether pwCF who have antibodies for SARS-CoV-2 have a differentclinical presentation and what impact this has on their CF disease. The proposed studywill recruit pwCF from paediatric and adult CF centres in Europe. Serological testing todetect antibodies will be performed on blood samples taken at month 0, 6, 12, 18 and 24with additional time-points if bloodwork is available via normal clinical care. Clinicaldata on, lung function, CF-related medical history, pulmonary exacerbations, antibioticuse, and microbiology and vaccination receipt, will be collected during routine clinicalassessments. Associations will be examined between socio-demographic and clinicalvariables and serologic testing. The effects of SARS-CoV-2 infection on clinical outcomesand analyse end-points will be examined to explore any age-related or gender-baseddifferences, as well as subgroup analysis of outcomes in lung-transplant recipients andpwCF receiving CFTR modulator therapies. As pwCF receive COVID-19 vaccination acomparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCFfollowing natural infection and vaccination SARS-CoV-2 over time will be performed

Detailed Description

Not Provided

Active, not recruiting
COVID-19
Cystic Fibrosis

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)

Eligibility Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- Refusal to give informed consent

- Contraindication to venepuncture

- For France

- Person under guardianship / curatorship

- Person under legal protection

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
France
Locations

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

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

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

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

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

Fondation Ildys
Roscoff, France

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

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

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

Not Provided

Queen's University, Belfast
NCT Number
MeSH Terms
COVID-19
Cystic Fibrosis
Fibrosis