The coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 hasresulted in an ongoing global pandemic. It is unclear whether the relatively low numberof reported cases of COVID-19 in people with CF (pwCF) is due to enhanced infectionprevention practices or whether pwCF has 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 sociodemographic and clinical variables andserologic testing. The effects of SARS-CoV-2 infection on clinical outcomes and analyzeend-points will be examined to explore any age-related or gender-based differences, aswell as a subgroup analysis of outcomes in lung transplant recipients and pwCF receivingCFTR modulator therapies. As pwCF receive COVID-19 vaccination a comparison of thedevelopment and progression of anti-SARS-CoV-2 antibodies in pwCF following naturalinfection and vaccination SARS-CoV-2 over time will be performed.
This is a prospective, longitudinal cohort study in people with Cystic Fibrosis (pwCF)
that involves the 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
centers over a 3-year period. Study participants will include pediatric and adult pwCF.
For the UK section of the study, UK investigators in the European Cystic Fibrosis
Society-Clinical Trials Network (ECFS-CTN) will be invited to participate. Participating
investigators can enroll 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 investigators 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 patient's medical records. Data will be collected at baseline,
months 6, 12, 18, and 24 as per the study schedule, and at additional blood sampling time
points 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.
The investigators will compare the level of antibody responses between natural COVID-19
infection and vaccination in pwCF and how this varies over time. This will be achieved by
analyzing seroprevalence and antibody levels according to natural infection and
vaccination status and according to time of sample post-infection or post-vaccination, if
known.
Optional Study sample collection:
For participants who consent, a second blood sample will also be drawn into EDTA tubes
(plasma). Consent to this optional study sample would allow this sample and any remaining
serum (following antibody testing) to be stored for future analysis and allow further
research to be carried out on related studies to COVID-19 and CF.
Inclusion Criteria:
- Inclusion Criteria:
- Consenting people with cystic fibrosis of any age, genotype, transplant status and
disease severity
Exclusion Criteria:
- Refusal to give informed consent
- Contraindication to venepuncture
Hospital Universitari Vall d'Hebron. Cystic Fibrosis Unit
Barcelona, Spain
Investigator: Silvia Gartner, MD
Contact: +34934893197
silvia.gartner@vallhebron.cat
Silvia Gartner, MD
+34934893197
silvia.gartner@vallhebron.cat
Antonio Alvarez, PhD
+34934893197
antonio.alvarez@vallhebron.cat
Silvia Gartner, MD, Principal Investigator
Hospital Vall d'Hebron