Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05012306 |
| Other study ID # |
V1.0_01-MAR-2021 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 28, 2021 |
| Est. completion date |
May 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Universitätsklinikum Köln |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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 United
Kingdom (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 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, the 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 Ethylenediamine
tetraacetic acid (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.
