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 1970 participants to participate.
COVERSCAN started recruiting in April 2020. Since that time, the research findings have supported the role out of COVERSCAN, which was given MHRA EUA (Emergency Use Authorisation) approval in January 2021 for its use to clinically support post-COVID19 sufferers. Therefore, in the summer of 2021, COVERSCAN was redefined as clinical investigation of a medical device trial, which will allow data from this study to be used to support future regulatory applications.
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 90ml (6 tablespoons) will be samled if you attend both study visits, including:
- A blood sample of around 20ml (1-1.5 tablespoons) at each study visit for general biochemistry, including kidney and liver tests.
- An additional blood sample during the first visit will be taken for genetic (DNA) analysis (5-10ml) to look for common variations in genes that affect how organs are affected by COVID-19 disease.
- An optional additional blood sample of around 20ml (1.5 tablespoons) for immunologic tests.*
*Where participants have already taken part in the COVERSCAN study, they may be given the option of returning to have these optional additional immunologic bloods taken. This will support further immunological research and development. An updated informed consent form will be signed.
The following procedures are OPTIONAL at each visit:
- Pulse oximetry - a non-invasive method for measuring oxygen saturation
- Spirometry – a non-invasive and simple way of measuring lung function
- Echocardiography – an ultrasound of the heart
- Cardiopulmonary Exercise Test – a test that involve assessing your aerobic exercise
- 6-Minute Walk Test – a non-invasive exercise test to assess your endurance
Each visit will take approximately 2 hours.
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 40ml of blood (around 2-3 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.
Optional Procedures
Some participating sites will offer optional additional procedures that you may choose to complete if you wish. These are:
Spirometry (Optional):
Spirometry is a common lung function test. It is helpful in assessing breathing patterns. We will ask you to blow into a small machine that will help us to assess how well your lungs work by measuring how much air you inhale, how much you exhale and how quickly you exhale. The test should take around 10 minutes.
Pulse Oximetry (Optional):
A pulse oximetry test allows us to measure the amount of oxygen in your blood. It is a simple test that involves a small, painless clip to be put on your finger. It provides a measurement within seconds.
Echocardiography (Optional):
You will be given the option to have an ultrasound scan of your heart. This scan is called an echocardiogram, or ECHO, and will be used to assess the size and function of your heart. The procedure requires you to lie down on your side and have a probe placed on your chest whilst images of the heart are acquired. There are no known risks with ultra sound scanning. The scan should take around 30 minutes.
Cardiopulmonary Exercise Test (Optional):
You will be given the option of undergoing a cardiopulmonary exercise test (CPET) to help us assess your exercise capacity (in other words, your aerobic fitness). This assessment is very popular throughout the world as a way of assessing a person’s aerobic fitness. The procedure requires you to ride on a static exercise bike that allows us to measure the work you’re putting into the exercise. The test will start at a low/easy intensity, and gradually increase, causing you to put more effort into the exercise. During the test, your heart rate will be tracked – this will be done by putting sticky patches, called electrodes, on your chest and connecting it to an ECG. In addition, you will be asked to wear a facemask, which will allow us to assess your lungs (for specifically, your how much oxygen you use) during the exercise. We will take a blood sample using a finger prick test at the start of, and at various times during, the test. During the test, you will also be asked some questions about the effort you are using. If, at any point during the exercise test you do not wish to continue, you may ask to stop at any time. This will not affect your participation in the study.
6-Minute Walk Test (Optional):
You will be asked to walk as far as possible within 6-minutes within an indoor pre-marked corridor. This will help us assess your endurance. You will be asked some questions before and after your walk about how you feel, as well as your heart rate and oxygen saturation being measured. If, at any point during the walk test you do not wish to continue, you may ask to stop at any time. This will not affect your participation in the study. We will also take a blood sample using a finger prick test at the start and end of the walk test.
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 further blood samples (around 40ml), 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 ionising radiation. Safety checks are carried out prior to an MRI including information from your medical and personal history. MRI scans are considered lower risk because of the absence of ionising radiation compared to CT and general X-ray imaging and there are no known lasting side effects from the strength of scanners that we use. Some temporary side effects you may experience during the scan include an increase in temperature and peripheral nerve stimulation such as in your hands or feet. 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.
Echocardiogram
Echocardiogram is a type of ultrasound scan with no known risks.
Cardiopulmonary Exercise Test
The risk for CPET is the same as for mild-moderate exercise. You will be monitored closely during the test with continuous ECG and oxygen measurements. The exercise requires you to put maximal effort into the test. Therefore, we will ask you to perform a warm up and cool down during the testing session. If there are any concerns regarding your safety during the exercise testing, you will be asked to stop.
6-Minute Walk Test
A 6-minute walk test is a type of exercise test with no known risks.
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. You will also receive an overview of your research results during the course of the study following review by the study team (the timing of this will be dependent on our analysis pipeline).
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. As we begin to learn and understand more, the study team and its investigators will host regular webinars throughout the course of the study to keep participants actively informed on the progress of COVERSCAN, including any interim results. The study team might also send out occasional surveys to collect information about your feedback and experience. New and updates will also be available via participant email newsletters, as well as the COVERSCAN website – www.coverscan.com
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.
How will we use information about you ?
We will need to use information from you, your medical records and your GP for this research project. This information will include your initials, name and contact details. People will use this information to do the research or to check your records to make sure that the research is being done properly.
People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.
We will keep all information about you safe and secure.
Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.
What are your choices about how your information is used?
You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.
We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.
If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study. [Insert details of any specific bank/ repository]
Where can you find out more about how your information is used ?
You can find out more about how we use your information:
- by asking one of the research team,
- by sending an email to coverscan@perspectum.com
- at www.hra.nhs.uk/information-about-patients/
- our leaflet available from www.hra.nhs.uk/patientdataandresearch
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. Additionally, samples may also be used to support pre-clinical work and development. 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. Pre-clinical work and development may be organised by either non-commercial or commercial laboratories/companies worldwide. Further to this, we will also ask for your optional consent to use your samples in both future research studies and also pre-clinical work and development that are not related to COVID-19 disease. Please be aware that we may be compensated when we share your samples with third parties. Any compensation we receive from third parties will be limited to reasonable amounts to cover our running costs.
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-diagnostics.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-diagnostics.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).