This is a study about COVID-19. This condition is caused by a type of virus called SARS-CoV-2, or coronavirus for short.
As COVID-19 is a new disease, this study aims to identify whether there are longer-term health problems of COVID-19 for those who were admitted to hospital.
We want to understand:
Finally, we want to develop a resource of data and samples that other researchers can use to answer their questions quickly to help improve outcomes in future. This will provide the best use of the time, data and samples you provide.
We have split the PHOSP-COVID study into three stages, and we will refer to these as Tiers 1, 2 and 3 throughout this information sheet. This information sheet contains detail about Tiers 1 and 2. Details about Tier 3 will be provided as and when these studies are ready to recruit.
You have been invited to take part because you were admitted to hospital with confirmed or suspected COVID-19. We will use information about you to try to find out what makes some people more vulnerable to COVID-19. A lot of the information, samples and scans we are interested in will have been collected as part of your normal medical care. We will also ask your permission to do additional tests that are not part of your normal visits to the clinic.
No, participation in the study is voluntary. It is up to you to decide whether or not to take part. If you do decide to take part you will be asked to provide verbal consent over the phone, sign a consent form at your next visit, consent via the website by following the instructions on the invitation letter, or post your signed consent form to your local research team using the pre-paid envelope provided. If you decide to take part you are free to withdraw from the study at any time and without giving a reason. If you do not take part, or if you withdraw from the study, this will not affect the standard of care you receive.
Tier 1 Participation = Requiring consent and access to your healthcare records only:
We will ask your permission to collect information from your routine health records such as your signs and symptoms, medications that you are taking, and the results of any blood test, questionnaires, laboratory results or imaging that your doctors have ordered. This will include all clinical records and case notes relating to your COVID-19 hospitalisation, as well as all of your GP, hospital and adult social care records from before and after your COVID-19 hospitalisation. This will enable us to collect data on your health and your use of support services outside of hospital (for example, if you need a carer). With your permission, we will continue to collect data from your electronic records for up to 25 years.
We will also ask your permission to use, obtain and store any leftover samples such as blood from tests that your doctor orders. We may use these samples to obtain measures of your DNA. If you have not had any blood samples taken we will send you a kit to provide a saliva sample (when it is safe to do so) that we will use to measure your DNA. If you do not wish for us to measure your DNA you can still participate in the study and opt out of DNA analysis when completing the consent form.
We will use your street address and postcode to link to environmental measures (for example, air pollution levels). We will only collect data that is required for the research and you may hear us refer to this data collection as ‘Tier 1’ research.
Tier 2 Participation = As described above but with additional samples or tests:
We will be asking some participants to provide additional research samples and undertake additional research tests. These tests and samples are not essential for your clinical care but will help us to undertake our research. You may hear us refer to these as ‘Tier 2’ research tests and procedures. You may be asked to attend a separate research visit at approximately 3 months and 1 year after your discharge from hospital to complete these tests. Some may be performed on the same day you attend the hospital for your usual appointments.
The additional ‘Tier 2’ research tests and samples that you may be asked to perform are detailed at the end of this document. These tests are mostly questionnaires, physical function tests, or samples such as blood tests. Before undertaking any test or procedure you will be given clear information about what it involves and how to do it. It is your choice as to whether or not you undertake some or all of them. You may be asked to participate in any single procedure or combination of procedures at these visits. You can choose not to participate in these additional tests or to provide samples at the time they are requested. If you do not wish to be asked to undertake any additional ‘Tier 2’ research testing, you can indicate this on the consent form.
We would like to do some blood tests when you are fasted. Therefore, if we are able to schedule a morning visit for you, we will ask you to fast from 10pm the night before. We will provide a drink and snack for you as soon as these blood tests have been taken and before undertaking any other research tests or procedures.
We will offer the option for you to complete the questionnaires digitally either through an app developed by the University of Oxford or by the internet. You will be able to complete the questionnaires at a time of your choosing rather than at a research visit or at a clinical appointment.
If you agree to be considered to take part in the additional ‘Tier 2’ research tests, you may or may not be asked to attend for separate research visits. This depends on the capacity and capability of the local hospital at the time you agree to take part. Or, you may be required to attend more than one NHS Hospital in order to participate in both Tier 1 and Tier 2 of the study. This is due to local capacity and capability arrangements at different hospitals. If this applies to you, you will be asked to sign a consent form at your Tier 1 hospital and then re-sign a part of the same consent form at the Tier 2 hospital. Therefore, a copy of your signed consent form will be transferred between the hospitals. Your local study team will tell you whether or not this applies to you when going through this information sheet.
Future PHOSP-COVID Tier 3 research:
We may contact you to invite you to ‘Tier 3’ sub-studies. Details of these ‘Tier 3’ sub-studies will be sent out when the study is ready to recruit participants. Even if you say you are happy for us to contact you about these future PHOSP-COVID Tier 3 studies, participation in them is optional. Your decision to take part in Tier 3 studies, or not, will not affect your participation in other parts of the PHOSP-COVID study or your current or future medical care.
If you are already enrolled in another research study, this will not affect your ability to take part in this study. Similarly, if you wish to take part in another research study you can remain in this one. We will ask your permission to link your information from other studies to the information collected for this study.
This is a complex study and involves many research and delivery partners, such as universities, hospitals, laboratories, data processing and logistic operators. To deliver the study we will need to share your personal information with some of these partners. We will only share the minimum information with these partners to undertake the task they are performing. They are bound by the same rules as us to keep your information confidential and safe.
For example, we would like to obtain information held centrally about you by the NHS, to do this, we will need to share your NHS number (or Community Health Index Number for Scotland) and other details so that they can find your records. We will request both information from the past, as well as future information collected over the next 25 years. It may include imaging or scans as well as data from your medical records. We will always share the minimum information in a secure manner.
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 access other research and public data, we will use your information along with that data to answer some of our research questions. Your primary care doctor will be informed that you are taking part in this study.
Some of your information may be sent to our partners outside of the European Economic Area (EEA), where data rules are different, however they must follow our rules about keeping your information confidential and safe.
We will write our study reports and publications in a way that no-one can work out that you took part in the study.
We will keep the minimum personally identifiable information about you indefinitely. This is for safety reasons and because it is a valuable record of this outbreak event. The information will be held securely and be under the control of the University of Leicester as the Sponsor and Data Controller.
A copy of your consent form will be kept with any samples that are retained, this is to demonstrate you gave us your consent to keep them. As with all of the study documents, these will be stored securely and the minimum number of people will have access.
Once we have finished the study we will transfer a copy of our research data into a Trusted Research Environment, also known as a “Data Safe Haven”. This is to allow as many researchers as possible to learn from the data we have collected and to conduct their own future ethically approved studies. Any link between the data and you will be stored separately and securely, meaning that researches accessing the Date Safe Haven will not be able to identify you.
We will gain your permission to inform your GP of your participation in the study.
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.
If you choose to stop taking part in the study, we would like to continue collecting information about your health from central NHS records/ your hospital/ your GP. If you do not want this to happen, tell us and we will stop.
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 would like to know more about how we will process your information you can review a Privacy Notice on our website, or ask a study team member for a printed copy https://www.phosp.org/
How data is used in research is complicated, if you have any questions, please ask one of the research team, or you can access further details via:
Contact information will be included in patient information sheet provided to you at your participating site.
The Data Protection officer is:
Data Protection Officer and In-House Commercial Lawyer,
University of Leicester,
0116 229 7640
As part of this study we will use the samples to look at how the body is affected by COVID-19. We will use samples to analyse your DNA (genetic variation), RNA (how your genes work) and other molecules. Some of the tests for this study may be done in different countries including outside the EEA.
Some samples and information from the study may be shared and made available to other researchers and partners, here and around the world. They will manage the samples and data safely and securely in line with the practices outlined above.
With your permission, we would also like to store your samples after this study has ended, to use them for future ethically approved research that is different to this study. If you agree your consent form will be retained until the sample has been used up or destroyed, this so we can show you provided your consent for us to keep it. The consent form will be transferred with the sample wherever it is kept.
Samples stored after this study ends will be stored in line with all relevant legislation, this may be in a secure central repository. If you wish to find out further information on how we are using samples please speak with a member of the study team.
There is no direct benefit to you personally. The information we learn may help in caring for other patients in the future.
We will act on any test results including questionnaires that require follow-up. Most commonly this will be informing you and your GP of a particular result. Otherwise, you and your GP will not receive the outcome of any test or assessment.
If you take part in the study and we collect data from your records there is minimum risk, all information will be used anonymously (no one will know that this information relates to you).
If you are asked and you agree to provide additional samples, being a part of this study means that more samples will be taken than are needed for normal care. Whenever possible these samples will be taken at the same time as regular samples to reduce the extra procedures. There is a risk of pain or discomfort when samples are taken, and these are detailed earlier in the information sheet.
As part of your clinical care you may have CT scans of your chest which may be performed a certain way due to this study. As part of this study you may be asked to have a whole-body DEXA scan. This involves using X-rays to form images of your body and provide us with other clinical information. X-rays can cause cell damage that may, after many years or decades, turn cancerous. We are all at risk of developing cancer during our lifetime. The normal risk is that this will happen to about 50% of people at some point in their life. Taking part in this study will add only a very small chance of this happening to you.
The DNA, RNA and other molecules measured using your samples will be looked at to try and work out what contributes to the risk of getting COVID-19, how severe the infection is and how people recover from it. These will be looked at in batches and will not have any details on them about who they belong to, therefore, we will not attempt to identify you or inform you of any results from your sample testing.
You and your GP will not receive individual results from these tests as they are not being used for diagnostic purposes, they are solely for research and safety purposes.
It is unlikely that you will be harmed by taking part in this study. If you wish to complain about any aspect of the way in which you have been approached or treated during the course of this study, you should contact your local investigator <<insert local investigator>> <<insert contact details>> or you may contact the study coordinator. You can find contact details for your local research team on the paper information sheet provided to you or via the participant section of the website.
If something does go wrong and you are harmed during the research and this is due to someone’s negligence then you may have grounds for legal action for compensation against the University of Leicester but you may have to pay your legal costs. The normal NHS complaints service will still be available to you (if appropriate).
Yes, you can withdraw at any time without giving a reason and without this affecting your care. We would like to ask you to complete a withdrawal form. This is so we are clear whether or not we can continue to access your electronic healthcare records. We would like to continue to access your records for up to 25 years. If you do not want this to happen, you can tell us on the withdrawal form. If you do decide to withdraw then any information and samples already collected will remain and be used in the study. No further samples or data collected will be performed and we will not contact you again about this study.
With your permission, we may contact you about future research studies that you may be interested in and eligible for. This is entirely optional and agreeing to be contacted also does not oblige you to take part in any future research.
If you agree your contact details would be stored electronically on a secure server and only authorised individuals at your local NHS Trust will have access to it. You can ask us to have your contact details removed from our database at any time by contacting your local research team, or at the time you receive an invitation for future research.
You will be undertaking testing at your normal clinic appointments so you will not receive any payment or reimbursement for participating in this study. If you undertake any research specific visits to the research team then car parking reimbursement or other reimbursement for travel can be provided.
This is a research study organised by the NIHR Leicester Biomedical Research Centre and sponsored by the University of Leicester. The trial is being funded by the National Institute for Health Research UK Research and Innovation. None of the doctors will be paid themselves for including you in the trial.
All research that involves NHS patients or staff, information from NHS medical records or uses NHS premises or facilities must be approved by an NHS Research Ethics Committee before it goes ahead. This trial has been approved by Leeds West Research Ethics Committee. Approval does not guarantee that you will not come to any harm if you take part. However, approval means that the committee is satisfied that your rights will be respected, that any risks have been reduced to a minimum and balanced against possible benefits and that you have been given sufficient information on which to make an informed decision.
The study has also been reviewed by the Health and Social Care Public Benefit and Privacy Panel.
If you would like more information about the study you can contact the Local Investigator in your hospital or telephone the Local Research office. You can find contact details for your local research team on the paper information sheet provided to you or via the participant section of the website.
It is your choice whether or not to take part. Your usual clinical care and participation in the study will not be affected if you choose not to undertake additional tests and procedures if asked. You will be supervised throughout all of the assessments and you can stop the at any time by talking to a member of the research team.
The tests and procedures below will only be requested if they have not been performed as part of your clinical care.
We will take blood samples which we will use to obtain measures of your DNA and other molecules in your blood. We will only take up to 100ml (less than 6 tablespoons) of blood
within a 4 week period. This may cause some mild discomfort and occasionally
some bruising. If they have not already been requested as part of your
clinical care we will also send a number of blood tests for clinical testing
for example a blood count, kidney and liver function, a hormone from your
heart, a test for diabetes, tests similar to cholesterol, vitamin D
You may be asked to provide a saliva/spit sample into a small tube either whilst you are at the hospital or when at home. You will need to refrain from smoking, eating, chewing gum or drinking for up to 30 minutes before providing the sample. You may be asked to gargle a sterile saline solution in order to do this. Saliva samples may be used to measure your DNA and to measure the levels of other molecules and organisms in your spit.
We will analyse your sputum sample in the laboratory to measure the types of cells, inflammatory chemicals and organisms in it.
We will collect a few different samples from your nose. A small piece of material will be inserted into the nostril to collect fluid. This material will be kept inside your nostril for one minute. This may make your eyes water but should not be painful. We may also use a small brush or scoop, which is inserted and gently rubbed inside the nostril. This takes a few seconds to do. This may cause some discomfort and sometimes induces sneezing, coughing and, rarely, minor bleeding for a short period of time. We may also take a swab from your throat and nose, like the one that is taken when the coronavirus test is done.
We will ask you to provide a urine sample in a small pot either at home or during your visit.
We will ask you to complete various questionnaires that ask you about your health and symptoms. This could include questions about your physical and mental health. Some questionnaires may be led by a member of the study team who will be asking the questions, other questionnaires you will be asked to complete yourself.
With your permission, we may also contact you by post, email or telephone to ask you further questions about your ongoing health and lifestyle.
An electrocardiogram (ECG) is a simple test that can be used to check your heart's rhythm and electrical activity. Sensors attached to the skin are used to detect the electrical signals produced by your heart each time it beats. It is quick and painless and will only take 5 to 10 minutes.
We may ask you to perform breathing tests called spirometry and transfer factor which assess how the air tubes and air sacs in the lungs are working. Spirometry is a simple breathing test which involves breathing out as hard as you can several times. Transfer factor measurement is carried out with you sitting in a transparent glass booth. This test measures how your lungs take up oxygen from the air you breathe.
A further test will involve breathing in and out of a handheld device that
uses sound waves to measure your airways (this is called oscillometry). We
may also ask you to perform a similar test that measures the molecules in
the air that you breathe out. These breathing tests may cause some temporary
light headedness and coughing.
We may ask you to perform some exercise testing such as, walk test, balance test, muscle strength test such as a hand grip and thigh strength or other similar exercise test using a stationary bike which involves wearing a tight fitting mask so we can collect samples of the air you breathe out. We will provide you with the necessary instructions depending on the specifics tests involved.
Physical Activity monitoring:
We may also ask you to wear an activity monitor that measures your activity levels. This is a small lightweight device that you will be asked to wear on your wrist for two weeks and post back to the research team in a pre-paid envelope. We may also ask you to complete a log for these 2 weeks on when you wear the device and your sleep patterns.
We may ask to assess your body composition. This assesses the proportion of muscle as a total of all body tissues. There are different ways to measure this.
Bioelectrical impedance can be assessed by different equipment but commonly this is with a digital weighing scale. The exact procedure will be discussed with you.
Dual energy x-ray absorptiometry (DEXA) scanning. This is like a chest x-ray, but requires you to lie down. It measures the proportion of muscle, fat and bone density in your body. The radiation dose from each DEXA scan is equivalent to radiation from less than 1/10th of a
chest x-ray or three hours of background radiation. Chest x-rays expose you to a minimum amount of radiation. The scan will take approximately 10 minutes.
We may ask permission to do more detailed tests of your thigh muscles:
We will measure the size of your quadriceps muscle using ultrasound. This is a non-invasive scan where we gently place a probe over your leg with jelly to get a picture. This will be done whilst you lie in your bed and takes about 5 minutes.
We may ask you if you will have a small sample of muscle taken called a muscle biopsy. This is from your edge of your thigh muscle. Local anaesthetic is used to numb any pain, though this may sting as it is injected. We then make a small cut in the skin (about 5mm) and use a needle to take a sample of your muscle (up to the size of a pea). The procedure is very safe, though your leg may ache for a day afterwards. There may also been some bruising around the site of the biopsy, called a haematoma.
Some people will be invited to undertake a semi-structured interview with an experienced interviewer. This will be either by telephone or face to face. The interview may last up to one hour. A semi-structured interview is a flexible interview that allows new questions to be asked as a result of what the interviewee says. Questions will be based around your experiences of COVID19 infection, recovery, after effects and any interventions or care you received. The interview will be audio-recorded and will be professionally transcribed (written down) at a later time. All identifiable information, such as your name, will be removed. We may quote some of your comments in the work that is published as a result of this study, but you will not be identifiable from this published work.
The recordings will be deleted from the dictaphone once uploaded. The recording will be uploaded to a secure drive on either University of Leicester or University Hospitals of Leicester NHS Trust computers. Access to the files will be restricted and password protected."