COVID-19 Antibody Responses in Cystic Fibrosis:CAR-CF
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 113
- Locations
- 2
- Primary Endpoint
- To evaluate SARS-CoV-2 seroprevalence
Study Overview
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. We 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 CFTR modulator therapies. As pwCF receive COVID-19 vaccination we 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.
Detailed Description
This is a prospective, longitudinal cohort study in people with Cystic Fibrosis (pwCF) that involves repeated serial sampling of participants. This study design was chosen to provide comprehensive information on SARS-CoV-2 seroprevalence changes over time and the subsequent clinical impact on pwCF. The study will be conducted at participating CF centres over a 3-year period. Study participants will include paediatric and adult pwCF. Participating investigators can enrol all eligible pwCF over a 12-month period. Participants are then followed up for 24 months. Participants will donate blood samples at their routine clinic visits. Blood samples will be collected at Day 0 (baseline), at Months 6, 12, 18 and 24 (to coincide with routine clinical reviews). Additional blood samples will be taken opportunistically every time the participant visits the clinic for blood draws. These blood samples could be related to, routine care, annual review visits, pulmonary exacerbations (PEx), CF complications or when initiating new treatments (e.g. CFTR modulators).
Serum from blood samples will be shipped to a central laboratory (Queen's University Belfast) for standardized measurement of SARS-CoV-2 antibodies.
Alongside the blood samples the investigator will also collect clinical data from the patient's health records and will input this data into the case report form (CRF). Clinical data will be collected in
conjunction with routine care visits, according to local clinical practice. Investigators will collect data elements from information routinely recorded in the patients' medical records. Data will be collected at baseline, month 6, 12, 18 and 24 as per the study schedule, and at additional blood sampling timepoints as previously explained above. Data collection will include routine data available from CF clinic follow-ups including background demographic information, CF medical history, medications, exacerbation information, sputum microbiology and clinical and lung function parameters. Information on SARS-CoV-2 infection history and vaccine receipt will also be collected.
The maximum follow-up duration of participation in the study for each patient will be 24 months. This study duration (24-month follow-up) is justified as it provides sufficient time to observe changes in antibody prevalence over the course of the COVID-19 pandemic as well as sufficient time to determine long term clinical outcomes for pwCF who are SARS-CoV-2 seropositive. Furthermore, we anticipate the 2-year study follow-up period will provide sufficient time to observe the impact of vaccination on antibody levels given that a number of vaccines are now commercially available.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •There are no specific exclusion criteria other than refusal to give informed consent, or contraindication to venepuncture.
- •Participants already enrolled in a clinical trial are eligible for enrolment in this study. Inclusion in CAR-CF should not preclude enrolment in other observational clinical trial studies or clinical trials of an investigational medicinal product (CTIMP).
Outcomes
Primary Outcomes
To evaluate SARS-CoV-2 seroprevalence
Time Frame: 3-year period (comprising a 1-year enrollment period and a 2-year follow-up)
To evaluate SARS-CoV-2 seroprevalence in a cohort of people with cystic fibrosis, followed longitudinally over a 3-year period
To perform a longitudinal comparison
Time Frame: 3-year period (comprising a 1-year enrollment period and a 2-year follow-up)
To perform a longitudinal comparison of the development and progression of anti-SARS-CoV-2 antibodies in people with cystic fibrosis following natural infection and vaccination SARS-CoV-2
To examine the associations
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
Secondary Outcomes
- Storage of samples for future analysis(anticipated 5-10 year)