What next?
What next?
About this study
Although the COVID-19 vaccination program has proven very successful for most people, clinically vulnerable people, including those with pulmonary fibrosis, remain at a higher risk of COVID-19 despite having the vaccinations.
Antibodies form an important part of the immune response which helps the body to fight infection. There is some evidence that this response to the vaccination is important for how effective the vaccination will be. It is not clear whether this is true in all clinically vulnerable groups and there appears to be differences between individuals with the same condition. There may be other factors that play a role, including other parts of the immune system, other health conditions, particular medicines, or things like age.
This study aims to investigate which factor or combination of factors predicts an individual’s risk to COVID-19.
There are many different types of research. These studies might ask participants to test different treatments, devices, or complete questionnaires. Some studies may not require any involvement from people affected by PF, but instead look at cells in a lab environment, animal models, or utilise computer modelling.
A study involving people can be:
- Interventional – participants are given an active treatment decided by researchers. This could be a change in medication or lifestyle (e.g. exercise, diet, complementary wellbeing therapy, or symptom management). These are commonly known as clinical trials.
- Observational – participants are assessed for specific changes over time, but researchers do not alter their standard treatment or care (e.g. questionnaires to understand the impact of symptom, or patient registries that track trends in how disease affects people or the services that are provided).
There are 3 main phases of clinical trials:
- Phase 1 is the earliest stage of research, where there is often a focus on understanding if the treatment is safe or if it causes any side effects.
- Phase 2 still focuses on safety and side effects, but also tries to find out more about what is the best dose.
- Phase 3 often compares the new treatment to existing treatments or lookalike medications.
As drugs or interventions move into the different phases, the number of people taking part will increase. Not all studies will make it to the later phases, especially if the intervention is not found to be safe or effective in phase 1 and 2.
The recruitment aim is the number of people that researcher want to take part in the research study.
What is involved?
There are two ways you can take part in this study.
You can either:
- Attend 4 appointments face to face with your local clinical team at the hospital. If you choose to attend face to face appointments, you will have the option to either sign the online consent form or be consented at your first appointment with your local study team.
On each occasion you will be asked to provide:
• Blood samples
• Saliva test
• Nasal secretion test
OR
- You can join the study remotely. The central study team will send you a home sampling kit, called a dried blood spot, this allows you to prick your own finger and collect spots of blood.
For both ways fo taking part, you will be asked to provide your contact details (full address, contact number, NHS number if you know it, and GP information) to allow the researchers to check your medical and vaccination details.
During the study, you will be asked three times to fill in a questionnaire to understand whether your medical conditions or medications have changed and to check that whether you have had a COVID-19 infection.
Throughout the study, you will be kept in contact with the study team about how the study is progressing, to see if you are happy with your ongoing participation in the study and to offer any support you need with the study.
Summary of involvement
Remote or face to face participation
Blood samples
Saliva and nasal secretions test
Questionnaires to understand your medical conditions and medications
Can I take part?
You may be able to take part if you have a medical condition, including pulmonary fibrosis, that increases your risk of developing severe COVID-19.
In research studies, there are lots of different reasons why you may or may not be able to take part. These are known as inclusion and exclusion criteria (see list below). Only the research team will be able to fully determine whether you are able to take part in the study. You can withdraw at any point.
If you are not able to take part in this research study, there may be other opportunities for you to take part in different studies.
To find out more about other research opportunities visit our research finder main page.
People who have a health condition or take medication that can affect the functioning of their immune system. This includes people with pulmonary fibrosis.
Those who are unwilling to provide consent to take part.
What difference could taking part make?
The STRAVINSKY study will help to provide doctors, policymakers, and members of the public with up-to-date information on the impact of COVID-19 vaccinations for people with a wide range of different health conditions, including pulmonary fibrosis. It will help researchers to understand if antibody test results can predict an individual's risk of severe COVID-19 infection. The pulmonary fibrosis community have been significantly impacted by the COVID-19 pandemic and this study will help to understand more about the risk of infection.
Where does the study take place?
Study locations
Birmingham
Cardiff
Glasgow
Leicester
London
Oxford
Newcastle
Nottingham
Portsmouth
Sheffield
Southampton
You may still be able to take part in the study if you are not located near to one of the STRAVINSKY hospital sites, as there is a remote option for taking part from your home.
How to take part
If you would like to register your interest in taking part in the study, or if you have any questions, please contact the researcher by emailing stravinsky@contacts.bham.ac.uk
More information about the study can be found on the STRAVINSKY website.
Further information
This page is a summary which provides information about an opportunity to participate in research. More detailed information about the study can be found via the following the links and through contacting the research team.
If you have any questions about this research study, please speak to your medical team.
stravinsky@contacts.bham.ac.ukThis study is supported by
APF does not endorse or recommend any specific study. All responsibility for the study remains with the sponsors and investigators.
Every effort is made to keep these details up to date. If you are aware of any inaccuracies, please email research@actionpf.org