Coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 has resultedin an ongoing global pandemic. It is unclear whether the relatively low number ofreported cases of COVID-19 in people with CF (pwCF) is due to enhanced infectionprevention practices or whether pwCF have 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 socio-demographic and clinical variables andserologic testing. The effects of SARS-CoV-2 infection on clinical outcomes and analyseend-points will be examined to explore any age-related or gender-based differences, aswell as 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 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 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 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, investigators 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:
- Consenting people with cystic fibrosis of any age, genotype, transplant status and
disease severity
Exclusion Criteria:
- Refusal to give informed consent
- Contraindication to venepuncture
CHLN
Lisboa, Portugal
Investigator: Celeste Barreto
Investigator: Celeste Barreto, MD
Celeste Barreto, MD
00351210405814
celeste.barreto@chln.min-saude.pt
Not Provided