Why have I been invited?
You are being invited to take part as you have previously had a confirmed diagnosis for COVID-19 (the new coronavirus) disease. You have recovered, or are recovering from this disease, with no fever or cough with sputum for at 7 days or longer. You will be 18 years of age or over.
What is the purpose of the study?
The study aims to observe any changes in certain organs that were infected with COVID-19 disease. In particular, this will involve looking at the lungs, heart, kidneys, liver, pancreas and spleen. This will be assessed using Magnetic Resonance Imaging (MRI) and blood tests. We intend to recruit around 500 participants to participate.
What does the study involve?
- Telephone call and your consent to proceed
- 3 Questionnaire/s (online) that should take around 20 minutes in total to complete
- Two study visits at a study site closest to you; the start of the study at time zero and 6 months
- 2 MRIs (40 minutes per MRI) to take place at each study visit
- Height and weight to calculate Body Mass Index (BMI) score
- Blood pressure measurement
- A blood sample of around 20ml (1-2 tablespoons) at each study visit for general biochemistry including kidney and liver tests
- In total, approximately 45 ml of blood will be sampled if you attend all 3 study visits
- A blood sample at time zero for genetic (DNA) analysis to look for common variations in genes that affect how organs are effected by COVID-19 disease
Why is this study important?
This study is important for the current and future management of people who have, or are recovering from, COVID-19 disease.
How do I take part?
To take part, please electronically register your interest. Your registration will be completed on a secure web-based platform that will allow you to read and review the participant information leaflet before being allowed to electronically consent to participation in the study. You will also be asked to answer a few basic questions about your eligibility for the study.
Will I be given any reimbursement for travel?
A reimbursement of travel expenses, up to £20, will be available for each study visit.
Do I have to take part?
No. You decide whether or not to take part. If you decide to take part, you are free to withdraw from the study at any time without giving a reason. Your withdrawal or refusal to take part will have no effect on your current or future care. If you withdraw from the study and decide to no longer participate, any information and samples that have been collected for research purposes up until the time you withdraw will continue to be held and used for the study as outlined in this leaflet. To withdraw from the study, please contact the study team, whose contact details can be found at the end of this information leaflet.
What will happen if I take part?
Telephone Call
Soon after registering, a member of the study team will call you to discuss the study, answer any questions and ask you to complete the online informed consent form. If you need more time to consider, take as long as you want – a member of the team will call you back at a time most convenient to you.
Once you have given your consent, we will schedule your first visit. You will be asked to take part in two study visits at a study site closest to you. The study will take approximately 6-months.
Questionnaires
Prior to each of your study visits, you will be given access to online questionnaires which we will ask you to complete. These questionnaires will help us to understand more about your current breathing symptoms and other quality of life factors. At the end of the study, the pooled and anonymous results of the questionnaires will be available to all participants upon their request. No individual participant will be identified.
Medical History
Prior to each of your study visits, we will ask you some questions about your full medical history, including any medications you have taken or are currently taking. With your consent, the study team may request access to your GP records at a later date to obtain a more detailed medical history.
Visit 1 (Baseline)
During Visit 1, a detailed scan of your internal organs will be carried out using magnetic resonance imaging (MRI). This visit will also involve the following:
Basic Measurements
We will take your blood pressure, as well as your height and weight.
Magnetic Resonance Imaging (MRI)
MRI is considered a safe and non-invasive procedure as it does not use X-rays or any form of radiation. The MRI scanner uses a strong magnetic field to create detailed images of your body’s organs. The research team will ensure there is no reason to exclude your having an MRI scan, e.g. heart pacemaker, internal metal clips, pregnancy, among others. The study team will discuss safety aspects with you before you are enrolled into the study.
Each scan will take about 40 minutes in total. During the scan, you will be asked to lie on your back on a table that slides you into the scanner. You will be asked to hold your breath for 12 seconds at a time. The radiographer will practice this with you prior to the beginning of the scan. Should you feel the need to stop the scan, you can do so at any point by pressing a button that informs staff to stop. They will then slide you out of the scanner. Earplugs and/or headphones will be provided with the scan to limit noise and you may have the option to listen to music during the scan. We will ask you to fast (no food or liquids except water which you are encouraged to drink) for a minimum of 3 hours prior to each MRI scan to improve image quality.
The scans we do are for research purposes only. If any significant abnormality is found, we will tell you and, with your consent, send the report to your GP for further action.
Blood Sample
We will ask to take up to 20ml of blood (around 1-2 Tablespoons). For Visit 1 only we will also collect blood (less than 5ml or a teaspoon) for genetic testing as we have previously found some genetic patterns linked to inflammation.
Visit 2 (6 month)
Prior to Visit 2, we will ask you to complete another online questionnaire, the same as that completed at Visit 1. Visit 2 will occur around 6 months after Visit 1. In this visit, we will carry out another MRI scan, take a single blood sample, as well as taking some basic measurements (blood pressure, height and weight).
Following Visit 2, your active participation in the study will end.
Are there any possible disadvantages or risks from taking part?
MRI
Magnetic resonance imaging does not use radiation. MRI scans are very safe and there are no known major side effects from the types of scanner that we use. The MRI scan can be noisy, and earplugs/headphones will be provided to protect your ears. The scan also involves lying flat in a slightly confined space and a small number of people find this uncomfortable. Whether magnetic resonance could potentially affect an unborn child is unknown, therefore, you should not take part in this study if you are pregnant or think you might be.
Blood tests
Some people find having blood drawn as uncomfortable and bruising at the needle site may occur. The study team is highly trained in drawing blood and will make you as comfortable as possible. Very rare potential risks associated with drawing blood include a blood clot (thrombosis), infection or inflammation around the needle puncture site.
What are the possible benefits?
There may be no personal benefit to you; however, this research study will hopefully help us understand more about how COVID-19 disease affects various organs in the body and how quickly they get better. Results of this research may also lay the foundation to improving and supporting new future treatment options available to people who experience COVID-19 disease.
Research is one of four key pillars of the UK government strategy to manage COVID-19. At present, we know that some recovering patients may have organ damage. However, we do not know how much and why some people are more affected than others.
What happens when the research study stops?
We aim to publish the results of this study in scientific and medical journals. We will also present the findings at scientific meetings for the benefit of the wider medical community and to increase general understanding of how we can improve the recovery of patients who have succumbed to this disease. You will not be identified in any publication or presentation and your personal and clinical details will remain strictly confidential. Any scientific publication arising from the research will be available upon request to all participants. If you wish to see your scan results, please let the study team know. We ask your permission to use your images and associated research data for academic publications and patient communication purposes. No materials will include your name, study ID, or contact details.
Access to pseudonymized study data and results will also be granted to Health Data Research UK (HDRUK), Public Health England (PHE) and to the World Health Organization (WHO) to support global efforts in better understanding this disease.
Will my information be kept confidential?
Yes. The study team will collect information concerning you as part of the study and will be able to identify you. The study research team has a duty of confidentiality to you as a research participant and shall only use your information as outlined within the information leaflet.
When sharing your information with us and our study partners, your name will be replaced with a unique study-specific number so that we cannot identify you directly from your research data - this is known as ‘pseudonymised personal data’. We will maintain a database which contains you study ID and contact details, but we will only link the information where necessary as explained in this leaflet. Results of diagnostic and/or other tests (blood) that have been stored, and/or clinical observations made during your participation in the research study will be labelled with a pseudonymised personal data code and your initials instead of your name. These samples and any information created from using these samples will be treated as pseudonymised personal data and will be used and shared as a pseudonymised personal data.
Responsible members of the study team and Regulatory bodies may be given access to your information for monitoring and/or auditing of the study to ensure that the research study is following the applicable regulations. All information that relates to you will be stored in our secure study database with a unique study code number that is not personally identifiable but will allow us to link together the different types of information. All such information will be kept strictly confidential.
OPTIONAL: You will be given the option to consent to Perspectum linking your study data to your identifiable information to allow us to contact you about ethically approved research investigations in the future that are specifically suitable to your health status.
The study staff will ensure that the participants’ privacy is maintained. The study will comply with the General Data Protection Regulation (GDPR) and Data Protection Act 2018.
What will happen to any samples that I give ?
All samples will be retained for future analysis and will be stored securely for up to 10 years and may be used in future research as our understanding of COVID-19 disease grows.
Some samples will be used for genetic research (DNA analysis). This research may be conducted by the study team or collaborating research teams. Your blood sample will be assigned a code and your data will also be identified only by this number. The material given to researchers will not have information that identifies you. However, your DNA is unique to you so it can never be completely anonymous.
The genetic tests would involve looking at common variations in genes that affect how organs are effected by COVID-19 disease. We do not propose to test for inherited genetic diseases, or for conditions that will involve any other members of your family. The results of these tests will not be shared with you.
If you give your consent, samples may be used in other future research studies related to COVID-19 disease which have ethical approval. Your anonymised samples will be used mainly by the study team, but ethically approved research projects may take place in hospitals, universities, non-profit institutions or commercial laboratories worldwide. Further to this, we will also ask for your optional consent to use your samples in other future research studies that are not related to COVID-19 disease.
What would happen if we find anything unexpected on your scan?
Since we do not carry out scans and blood tests for diagnostic purposes, these should not be a substitute for clinical appointments. Our scans are for research purposes only. However, with any suspected incidental finding that is deemed medically significant, a member of the study team and/or the Chief Investigator will contact your GP to discuss the results. Further investigations may need to be arranged if necessary. If you have given consent, your General Practitioner will be contacted and should be sought for ongoing care.
What would happen if something goes wrong or I have a complaint?
Complaints: If you have a concern about any aspect of this study, please contact the Head of Clinical Affairs at Perspectum who will liaise with the study’s scientific advisory board.
Email: safety@perspectum.com
Telephone: 01865 655343
Participation in future research
We will ask if we can contact you about future research activities. This is optional - you can take part in this study but decline to be contacted again. If you consent, we will link your contact details to your research data to identify research activities which are relevant to your health status. You can withdraw your consent for future contact at any time without prejudice.
What if there is a problem?
Perspectum, as Sponsor, has appropriate insurance in place in the unlikely event that you suffer any harm as a direct consequence of your participation in this study. Please telephone 01865 655343 or send an email to: clinicalresearch@perspectum.com
If you wish to complain about the way you have been approached or interacted with during the course of this study, you should contact the Chief Investigator. Please telephone 01865 655343 or send an email to: clinicalresearch@perspectum.com
Who is organising and funding the research?
The research is being organised and funded by Perspectum.
Who has reviewed the research?
To protect the interest of research participants, the research is reviewed and checked by an independent group of people called a Research Ethics Committee (REC). This research has been reviewed and given a favourable opinion by the South Central – Berkshire B Research Ethics Committee (REC reference: 20/SC/0185).