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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05074680
Recruitment Status : Recruiting
First Posted : October 12, 2021
Last Update Posted : May 27, 2022
Sponsor:
Collaborators:
European Cystic Fibrosis Society
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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 in Europe. 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.


Condition or disease Intervention/treatment
Cystic Fibrosis Diagnostic Test: Blood sampling

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. 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, 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 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 : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVID-19 Antibody Responses In Cystic Fibrosis
Actual Study Start Date : February 14, 2022
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024



Intervention Details:
  • Diagnostic Test: Blood sampling
    Blood serum samples will be collected for analysis of COVID-19 antibody levels. For participants who consent to the optional study, a second blood sample will also be drawn into EDTA tubes (plasma)


Primary Outcome Measures :
  1. SARS-CoV-2 seroprevalence [ Time Frame: 3-year period (comprising a 1-year enrollment period and a 2-year follow-up) ]
    Proportion of pwCF with at least 1 seropositive result over the study period and the difference in this proportion by age, geographical area and over time.

  2. Association of SARS-CoV-2 seropositivity [ Time Frame: 3-year period (comprising a 1-year enrollment period and a 2-year follow-up) ]
    Clinical symptoms and clinical outcomes in pwCF: incidence of symptomatic COVID-19 over the study period and severity; proportion of seropositive pwCF with subsequent CF exacerbation compared to pwCF who are seronegative; death rate in pwCF with at least one seropositive result compared to pwCF who are seronegative.

  3. Longitudinal comparison [ Time Frame: 3-year period (comprising a 1-year enrollment period and a 2-year follow-up) ]
    Longitudinal comparison of the detection including level and duration of anti-SARS-CoV-2 antibodies in pwCF following natural infection and SARS-CoV-2 vaccination.


Secondary Outcome Measures :
  1. Serum proteomic and genomic responses [ Time Frame: 3-year period (comprising a 1-year enrollment period and a 2-year follow-up) ]
    Serum proteomic and genomic responses of pwCF who are SARS-CoV-2 seropositive an seronegative.


Biospecimen Retention:   Samples With DNA
Blood serum samples will be collected for analysis of COVID-19 antibody levels. For participants who consent to the optional study, a second blood sample will also be drawn into EDTA tubes (plasma)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Consenting people (signed informed consent by participant or parent/caregiver in case of children <14 years) with cystic fibrosis of any age, genotype, transplant status and disease severity will be eligible to participate in the study. The study population is expected to be representative of the general CF population.
Criteria

Inclusion Criteria:

• Consenting people (signed informed consent by participant or parent/caregiver in case of children <14 years) with cystic fibrosis of any age, genotype, transplant status and disease severity

Exclusion Criteria:

  • Refusal to give informed consent
  • Contraindication to venepuncture. Participants already enrolled in a clinical trial are eligible for enrollment in this study. Inclusion in CAR-CF should not preclude enrollment in other observational clinical trial studies or clinical trials of an investigational medicinal product (CTIMP).

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): NCT05074680


Contacts
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Contact: Veerle Bulteel +32 479983839 ECFS-CTN@uzleuven.be

Locations
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Switzerland
University Children's hospital Bern Recruiting
Bern, Switzerland, 3010
Contact: Philipp Latzin, Prof    +41316329353    philipp.latzin@insel.ch   
Quartier Bleu, Bern, Lindenhofspital Not yet recruiting
Bern, Switzerland, 3012
Contact: Reta Fischer, MD       reta.fischer@hin.ch   
University Children's hospital, Zürich Not yet recruiting
Zürich, Switzerland, 8032
Contact: Alexander Moeller, Prof       alexander.moeller@kispi.uzh.ch   
University Hospital Zürich Not yet recruiting
Zürich, Switzerland, 8091
Contact: Carolin Steinack, MD       carolin.steinack@usz.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
European Cystic Fibrosis Society
Cystic Fibrosis Foundation
Investigators
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Principal Investigator: Reta Fischer Biner, MD Quartier Bleu, Lindenhofspital Bern Site PI
Principal Investigator: Alexander Moeller, Prof University Children's Hospital Zurich Site PI
Principal Investigator: Carolin Steinack, MD University Hospital Zurich Site PI
Principal Investigator: Philipp Latzin, Prof Switzerland Country PI, University Hospital Bern Site PI
Study Director: Damian Downey, MD Queen's University, Belfast
Additional Information:
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT05074680    
Other Study ID Numbers: 2021-01137
First Posted: October 12, 2021    Key Record Dates
Last Update Posted: May 27, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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 University Hospital Inselspital, Berne:
Cystic Fibrosis
SARS-CoV-2
COVID-19
Additional relevant MeSH terms:
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COVID-19
Cystic Fibrosis
Fibrosis
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases