COVID-19 Antibody Responses In Cystic Fibrosis

NCT05158829 | Unknown

• 1 other identifier: CAR-CF
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 6

Brief Summary

Coronavirus disease 2019 (COVID-19) which is caused by the virus Severe Acute Respiratory Syndrome Coronavirus-2 (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 throughout the United Kingdom. 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 investigators will also examine the effects of SARS-CoV-2 infection on clinical outcomes and analyse end-points to explore any age-related or gender-based differences, as well as subgroup analysis of outcomes in lung-transplant recipients and pwCF receiving cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies. As pwCF receive COVID-19 vaccination the investigators will perform 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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (3)

• To evaluate SARS-CoV-2 seroprevalence

  To evaluate SARS-CoV-2 seroprevalence in a cohort of people with cystic fibrosis, followed longitudinally over a 3-year period (comprising a 1-year enrollment period and a 2-year follow-up). \[ Time Frame: 3-year period (comprising a 1-year enrollment period and a 2-year follow-up) \] To examine the associations between SARS-CoV-2 seropositivity, clinical symptoms and clinical outcomes in a cohort of people with cystic fibrosis

  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 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)

• Storage of samples for future analysis

  anticipated 5-10 years

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 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 with cystic fibrosis of any age, genotype, transplant status and disease severity

You may not qualify if:

• Refusal to give informed consent

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (6)

Centro Regionale toscano di riferimento per la fibrosi cistica- Azienda Ospedaliero- universitaria Mayer

Florence, Italy

RECRUITING

Istituto G. Gaslini Centro Fibrosis Cistica

Genova, Italy

RECRUITING

UOS Fibrosi Cistica dell'Adulto, Fondazione IRCCS Ca' Granda Ospedale Policlinico

Milan, Italy

ACTIVE NOT RECRUITING

Centro Regionale per la Fibrosi Cistica Azienda Ospedaliero-Universitaria San Luigi Gonzaga

Orbassano, Italy

NOT YET RECRUITING

Ospedale Pediatrico Bambino Gesù di Roma Divisione Dipartimento di Pediatria

Roma, Italy

NOT YET RECRUITING

Centro Regionale per la Fibrosi Cistica Piemonte-Torino Sezione Infantile presso AOU Città della Salute e della Scienza

Torino, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

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

Study Officials

• Carla Colombo, MD

  Milan CF Center, Fondazione IRCCS Ca Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla Colombo, MD

CONTACT

0255032460; carla.colombo@unimi.it

Study Design

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

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: December 15, 2021
• Study Start: January 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 20, 2022

Record last verified: 2021-12

Locations

IT (6)