COVID-19 Antibody Responses in Cystic Fibrosis

COVID-19 Clinical Trial

— CAR-CF  

Official title:

Corona-Virus-Disease 2019 (Covid-19) Antibody Responses in Cystic Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05614336
• Other study ID #: 69HCL21_0478
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: June 2025

Study information

• Verified date: November 2022
• Source: Hospices Civils de Lyon
• Contact: Damian Downey, Dr
• Phone: 44 (0) 28 9032 9241
• Email: d.downey[@]qub.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Cystic Fibrosis
• Fibrosis

Intervention

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)

Locations

Country	Name	City	State
France	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	CRCM Pédiatrique Hôpital Sud - CHU de Rennes	Rennes
France	Service de pneumologie - Centre cardio-pneumologie Hôpital Pontchaillou - CHU de Rennes	Rennes
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

Sponsors (2)

Lead Sponsor	Collaborator
Hospices Civils de Lyon	Queen's University, Belfast

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	2 years
Secondary	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	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
Secondary	Serum proteomic and genomic responses of pwCF who are SARS-CoV-2 seropositive an seronegative	Serum proteomic and genomic responses of pwCF who are SARS-CoV-2 seropositive an seronegative	10 years maximum