Active not recruitingOBSERVATIONAL

COVID-19 Antibody Responses In Cystic Fibrosis

This UK study wants to understand more about COVID-19 and how it affects people living with Cystic Fibrosis (CF). Researchers will follow both adults and children with CF for two years to see how many develop antibodies to the virus. They will collect blood samples at regular times to check for these antibodies and also gather information about their general health, lung function, and any treatments they are receiving. The study aims to find out if having COVID-19 antibodies changes how CF affects people, and how responses to natural infection compare to those from vaccination. This will help doctors better understand how to support people with CF during future outbreaks.

At a glance

Status

Active not recruiting

Sponsor

Queen's University, Belfast

Enrolment target

1,000

Start

19 Nov 2021

Estimated completion

01 Aug 2027

Covid19 Cystic Fibrosis

What is this study about?

This study is all about understanding how COVID-19 affects people with Cystic Fibrosis (CF). When the pandemic first started, doctors noticed that fewer people with CF seemed to be getting very sick with COVID-19 compared to the general population. They want to find out why this might be. Is it because people with CF are extra careful, or do their bodies respond to the virus differently?

The main goal of the study is to check how many people with CF, including both children and adults, have developed antibodies to the SARS-CoV-2 virus (the virus that causes COVID-19) over a two-year period. Antibodies are like tiny soldiers your body makes to fight off infections. By looking at these, researchers can tell if someone has been exposed to the virus, either through getting sick or through vaccination.

Beyond just counting antibodies, the study will also look at whether having these antibodies changes how CF affects a person's health. For example, do they have different lung function, or need different treatments? The study will collect health information that doctors already routinely check, like how well their lungs are working, any medications they're on, and details about their CF history. This will help paint a full picture of how COVID-19 impacts people with CF over time.

Key takeaways

This study aims to understand COVID-19's impact on people with Cystic Fibrosis (CF).
It will track antibody responses to the virus in children and adults with CF for two years.
Information will be gathered during your routine CF clinic visits.
No new treatments are given; it's an observational study.
Your participation helps improve understanding and care for people with CF.

Who may be eligible?

This study is open to anyone living with Cystic Fibrosis in the UK, no matter their age, their specific CF gene type, whether they have had a lung transplant, or how severe their CF is. If you have CF, you could be considered for this study.

However, you cannot take part if you are unable or unwilling to give your agreement to be part of the study. Also, if there's a medical reason why you shouldn't have blood samples taken (like a problem with your veins), then this study wouldn't be suitable for you.

Importantly, if you're already involved in another clinical study or trial, you can still join this one. Taking part in this study won't stop you from joining other research projects in the future.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have Cystic Fibrosis (CF).
I am happy to give blood samples at my regular CF appointments.
I agree to let the research team access my medical records for study information.
I am willing to participate for a two-year period.
I can give my informed consent (or my guardian can for me).

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be followed for two years. Your involvement would mainly happen during your usual CF clinic visits. At these visits, a small blood sample would be taken to check for COVID-19 antibodies. These blood tests would happen when you first join the study, and then at 6, 12, 18, and 24 months later. If you have other blood tests as part of your normal care, additional samples might also be taken then.

The research team will also collect information from your existing medical records, which your doctors already keep. This includes details about your lung function, any chest infections, medications you're taking (like antibiotics or CFTR modulators), and your vaccination history. This information will be collected at the same times as your blood samples. You won't need to take any new medications just for the study, nor will you have extra clinic visits beyond what you normally have for your CF care.

Potential risks and benefits

Taking part in this study is mainly about helping researchers learn more about COVID-19 and CF, which could benefit others with CF in the future. You won't directly receive a new treatment, but your participation is valuable for science. The main risk involves giving blood samples, which might cause a little discomfort, bruising, or rarely, an infection where the needle goes in. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual CF medical care.

Locations (11)

University Hospital Southampton Nhs Foundation Trust
Verified postcode
Southampton, United Kingdom
University Hospitals Birmingham Nhs Foundation Trust
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Birmingham, United Kingdom
Birmingham Women'S and Children'S Nhs Foundation Trust
Verified postcode
Birmingham, United Kingdom
Leeds Teaching Hospitals Nhs Trust
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Leeds, United Kingdom
King'S College Hospital Nhs Foundation Trust
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London, United Kingdom
Royal Brompton & Harefield Nhs Foundation Trust
Verified postcode
London, United Kingdom
Nottingham University Hospitals Nhs Trust
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Nottingham, United Kingdom
Queens University Belfast
Verified postcode
Belfast, United Kingdom
NHS Greater Glasgow and Clyde
Verified postcode
Glasgow, United Kingdom
Cardiff & Vale University Lhb
Verified postcode
Cardiff, United Kingdom
Cardiff & Vale University Lhb
Verified postcode
Cardiff, United Kingdom

Common questions

What is an antibody and why are they looking for them?

Antibodies are special proteins your body makes to fight off infections like COVID-19. Finding them tells researchers if you've been exposed to the virus, either by being ill or having a vaccine.

Will I get any medicine as part of this study?

No, this study is about observing and collecting information, not giving new medicines. All treatments you receive will be part of your normal CF care.

How long will I be involved in the study?

If you join, you will be part of the study for two years, with regular check-ups during your usual clinic visits.

Will my doctors know I'm in the study?

Yes, your CF medical team will be involved and aware of your participation, as the study uses information from your existing medical records.

Can I stop being part of the study if I change my mind?

Yes, absolutely. You can withdraw from the study at any time without having to give a reason, and it won't affect your medical care.