Clinical trial NCT05614336: COVID-19 Antibody Responses in Cystic Fibrosis
Official title: Corona-Virus-Disease 2019 (Covid-19) Antibody Responses in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: COVID-19
Cystic Fibrosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: Queen's University, Belfast
First posted: 2022-11-14
Enrollment: 331
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


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

Primary outcomes:
measure: SARS-COV-2 seroprevalence
timeFrame: 2 years
Secondary outcomes:
measure: Association of SARS-CoV-2 seropositivity, clinical symptoms and clinical outcomes in pwCF
timeFrame: 2 years
measure: 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
timeFrame: 2 years
measure: Serum proteomic and genomic responses of pwCF who are SARS-CoV-2 seropositive an seronegative
timeFrame: 10 years maximum
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: C.R.C.M. Pédiatrique (Centre de Ressources et de Compétences en Mucoviscidose) Hôpital des Enfants-Pellegrin - CHU de Bordeaux
city: Bron
country: France
facility: Pneumologie, allergologie et Mucoviscidose - CRCM Lyon pédiatrie Hôpital Femme Mère Enfant /Groupement Est
city: Grenoble
country: France
facility: Centre de Ressources et de Competences de la Mucoviscidose (Enfants) CHU Grenoble Alpes - Hôpital Couple Enfant
city: Montpellier
country: France
facility: Service des maladies respiratoires Hôpital Arnaud de Villeneuve - CHU de Montpellier
city: Reims
country: France
facility: Service de pédiatrie générale et spécialisée American Memorial Hospital - CHU de Reims
city: Roscoff
country: France
facility: Fondation Ildys
city: Rouen
country: France
facility: Maladies respiratoires, allergologie - CRCM Mixte de Rouen Hôpital Charles Nicole - CHU de Rouen
city: Toulouse
country: France
facility: Service de pneumo-allergologie pédiatrique CRCM pédiatrique CHU de Toulouse - Hôpital des Enfants
city: Toulouse
country: France
facility: Service Pneumologie-Allergologie CRCM adulte Hôpital Larrey - CHU de Toulouse
Study officials:
References: