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COVID-19 Antibody Responses In Cystic Fibrosis (CAR-CF)

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ClinicalTrials.gov Identifier: NCT04904445
Recruitment Status : Not yet recruiting
First Posted : May 27, 2021
Last Update Posted : May 27, 2021
Sponsor:
Collaborators:
Queen's University, Belfast
Cystic Fibrosis Foundation
European Cystic Fibrosis Society - Clinical Trial Network
Information provided by (Responsible Party):
Dr. H.M. Janssens, Erasmus Medical Center

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 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. 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.


Condition or disease
Cystic Fibrosis

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. 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 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.

We 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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVID-19 Antibody Responses In Cystic Fibrosis
Estimated Study Start Date : June 1, 2021
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis




Primary Outcome Measures :
  1. 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

  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

  3. 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


Secondary Outcome Measures :
  1. Storage of samples for future analysis [ Time Frame: anticipated 5-10 years ]
    Storage of samples for future analysis on the impact of COVID-19 immune response in people with cystic fibrosis


Biospecimen Retention:   Samples With DNA

A 6-monthly blood sample will be collected when the participants attend clinic or hospital.

For participants who consent to the optional study, a second blood sample will also be drawn.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People with cystic fibrosis of any age, genotype, transplant status and disease severity at sites across Europe will be eligible to participate in the study
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 blood draw

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04904445


Contacts
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Contact: Hettie M Janssens, Dr +31 (0)10 7036263 h.janssens@erasmusmc.nl
Contact: Edmond HH Rings, Prof.dr. +31 (0)10 7036226 e.rings@erasmusmc.nl

Sponsors and Collaborators
Erasmus Medical Center
Queen's University, Belfast
Cystic Fibrosis Foundation
European Cystic Fibrosis Society - Clinical Trial Network
Investigators
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Study Director: Damian Downey, Dr Queen's University, Belfast
Additional Information:
Publications:

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Responsible Party: Dr. H.M. Janssens, Pediatric Pulmonologist, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT04904445    
Other Study ID Numbers: NL
First Posted: May 27, 2021    Key Record Dates
Last Update Posted: May 27, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. H.M. Janssens, Erasmus Medical Center:
Cystic Fibrosis
COVID-19
SARS-CoV-2
Seroprevalence
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases