Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04863573 |
| Other study ID # |
B21/07 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 19, 2021 |
| Est. completion date |
May 2024 |
Study information
| Verified date |
January 2022 |
| Source |
Queen's University, Belfast |
| Contact |
Damian Downey |
| Phone |
02895041135 |
| Email |
d.downey[@]qub.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
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 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 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.
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. 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 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, 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.
