COVID-19CAR-CFNCT05614336
COVID-19 Antibody Responses in Cystic Fibrosis
A study testing Blood sample in people with COVID-19 and Cystic Fibrosis, run by Hospices Civils de Lyon at 19 sites in France.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19, Cystic Fibrosis
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 19 sitesFrance
- Study dates
- 15 Jun 2022to 17 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Person with cystic fibrosis of any age, genotype, transplant status and disease severity.
- Express consent obtained after informing the patient and/or his legal representatives or parents In France, written and informed consent will be requested.
- For France, affiliation to a social security scheme or similar
Who cannot join
- Refusal to give informed consent
- Contraindication to venepuncture
- For France
- Person under guardianship / curatorship
- Person under legal protection
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites
C.R.C.M. Pédiatrique (Centre de Ressources et de Compétences en Mucoviscidose) Hôpital des Enfants-Pellegrin - CHU de Bordeaux
Bordeaux, 33076
Pneumologie, allergologie et Mucoviscidose - CRCM Lyon pédiatrie Hôpital Femme Mère Enfant /Groupement Est
Bron, 69677
Centre de Ressources et de Competences de la Mucoviscidose (Enfants) CHU Grenoble Alpes - Hôpital Couple Enfant
Grenoble, 38043
Hôpital Albert Calmette - CHU de Lille
Lille
Hôpital Jeanne de Flandre
Lille
CHU Timone-Enfants - APHM
Marseille
Service des maladies respiratoires Hôpital Arnaud de Villeneuve - CHU de Montpellier
Montpellier, 34295
CHU de Nice
Nice, 06002
Hôpitaux Pédiatriques de Nice CHU Lenval
Nice, 06200
Hôpital Cochin, AP-HP
Paris
Hôpital Necker Enfants Malades - APHP
Paris
Hôpital Robert Debré - APHP
Paris
Service de pédiatrie générale et spécialisée American Memorial Hospital - CHU de Reims
Reims, 51092
Service de pneumologie - Centre cardio-pneumologie Hôpital Pontchaillou - CHU de Rennes
Rennes, 35033
CRCM Pédiatrique Hôpital Sud - CHU de Rennes
Rennes, 35203
Fondation Ildys
Roscoff, 29684
Maladies respiratoires, allergologie - CRCM Mixte de Rouen Hôpital Charles Nicole - CHU de Rouen
Rouen, 76000
Service de pneumo-allergologie pédiatrique CRCM pédiatrique CHU de Toulouse - Hôpital des Enfants
Toulouse, 31059
Service Pneumologie-Allergologie CRCM adulte Hôpital Larrey - CHU de Toulouse
Toulouse, 31059
About this study
Official title: Corona-Virus-Disease 2019 (Covid-19) Antibody Responses in Cystic Fibrosis
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
- Conditions
- COVID-19, Cystic Fibrosis
- Being tested
- Blood sample
- Medical subject headings
- COVID-19, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
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)
| Study group | Role | What they receive |
|---|---|---|
| Cystic Fibrosis patients | Other | Patients with cystic fibrosis, regardless of age, genetic profile, transplant status and disease severity will be eligible to participate in the study. Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-COV-2 seroprevalence
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.
Measured: 2 years
Secondary outcomes (3)
Association of SARS-CoV-2 seropositivity, 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.
Measured: 2 years
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
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
Measured: 2 years
Serum proteomic and genomic responses of pwCF who are SARS-CoV-2 seropositive an seronegative
Serum proteomic and genomic responses of pwCF who are SARS-CoV-2 seropositive an seronegative
Measured: 10 years maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start15 Jun 2022
- Primary completion17 Sep 2025
- Study completion17 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University, Belfast
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614336
- Sponsor's protocol ID
- 69HCL21_0478
- Acronym
- CAR-CF
- Status last verified
- Feb 2026
- First submitted
- 10 Nov 2022
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corona-Virus-Disease 2019 (Covid-19) Antibody Responses in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT05614336
- Acronym / sponsor ID
- CAR-CF / 69HCL21_0478
- Conditions
- COVID-19, Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Queen's University, Belfast
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 17 Sep 2025 (actual)
- Study completion
- 17 Sep 2025 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cystic Fibrosis patients | Other | Biological: Blood samplePatients with cystic fibrosis, regardless of age, genetic profile, transplant status and disease severity will be eligible to participate in the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Person with cystic fibrosis of any age, genotype, transplant status and disease severity.
- Express consent obtained after informing the patient and/or his legal representatives or parents In France, written and informed consent will be requested.
- For France, affiliation to a social security scheme or similar
Key exclusion criteria (5 listed)
- Refusal to give informed consent
- Contraindication to venepuncture
- For France
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleBlood 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) | Biological | Cystic Fibrosis patients |
Primary outcome
SARS-COV-2 seroprevalence
Time frame: 2 years
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.
3 secondary outcomes
Association of SARS-CoV-2 seropositivity, clinical symptoms and clinical outcomes in pwCF
Time frame: 2 years
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
Time frame: 2 years
Serum proteomic and genomic responses of pwCF who are SARS-CoV-2 seropositive an seronegative
Time frame: 10 years maximum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with COVID-19 and Cystic Fibrosis, run by Hospices Civils de Lyon at 19 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-COV-2 seroprevalence (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.