Thank you for your interest in the RECOVERY Trial. This trial is recruiting people who have been admitted to hospital with suspected or confirmed COVID-19. We hope the video and Frequently Asked Questions on this page address any questions you might have.
Your doctors have found, or suspect, that you have a lung disease called COVID-19. This condition is caused by a type of virus called SARS-CoV-2, or coronavirus for short. About 19 out of 20 patients who get coronavirus get better without coming to hospital. Of those who are admitted to hospital, most also get better, but some may need oxygen or mechanical ventilation before they do so. However, a few percent do not get better.
This trial showed that low doses of dexamethasone (a type of steroid) reduces the risk of dying for some patients hospitalised with COVID-19. There are several others which may turn out to be helpful (or possibly harmful) when added to the usual standard of care. This study aims to find out whether any of these additional treatments are of any help.
This study aims to compare several different treatments that may be useful for patients with COVID-19. These treatments have been recommended for testing by the expert panel that advises the Chief Medical Officer in England. Although these treatments show promise, nobody knows if any of them will turn out to be more effective in helping patients recover than the usual standard of care at your hospital (which all patients will receive).
The treatments, which may be given in addition to the usual care at your hospital, include Baricitinib (in UK only), a treatment for rheumatoid arthritis), high dose dexamethasone (if you have low oxygen levels; outside UK only) or empagliflozin. At present, we don’t know whether any of these are effective in treating COVID-19. However, the side-effects are well-known from other uses and your doctor will be able to monitor you appropriately. At some sites we may also assess other treatments; further details are on the last page and your study team can tell you if this is relevant for you or not.
The study is being conducted by researchers at the University of Oxford, which acts as the sponsor for the research, working with doctors at many hospitals across the UK.
Patients may be included in this study if they have COVID-19 confirmed by a laboratory test for coronavirus (or considered likely by their doctors), and are in hospital. Patients will not be included if the attending doctor thinks there is a particular reason why none of the study treatments are suitable.
If you decide to join, you will be asked to sign the consent form. Next, brief details identifying you and answering a few questions about your health and medical conditions will be entered into a computer. Women of child-bearing potential will have a pregnancy test. The computer will then allocate you at random (like rolling a dice) to one of the possible treatment options. In all cases this will include the usual standard of care for your hospital and it may also include an additional treatment. Neither you nor your doctors can choose which of these options you will be allocated.
Additional information about your health will be recorded and entered into the study computer but no additional visits will be required after you leave the hospital. Information about your health (both prior to, during, and after the study) may be obtained about you from medical records or databases (including NHS Digital, Public Health England, other equivalent bodies, and genetic or other research databases if you have provided samples to them) so that the study team can get more detailed or longer term information about the effects of the study treatments on your health for up to 10 years after the end of your participation. We may write to you to tell you about the trial periodically, but you will be able to opt-out of these communications if you prefer. Your GP may be informed of any issues relevant to your participation in the trial.
We do not know if any of the treatments being tested will have additional benefits. Your study treatment may or may not help you personally, but this study should help future patients.
Baricitinib may cause tummy upset and blood test abnormalities, rarely including low blood counts, for which you will be monitored. They may increase your risk of other infections, as might high dose dexamethasone which may also disturb sleep and (in people with diabetes) raise blood sugar.
Empagliflozin may cause urine or genital tract infections, like thrush. If you have diabetes, empagliflozin also lowers blood sugar in people taking insulin or some other diabetes treatments so your doctors may adjust the doses of those; it may also cause a condition called ketoacidosis (which rarely can be life-threatening), which is treated with a drip and insulin. You will be monitored for this with daily fingerprick blood or urine tests. There is also the unlikely possibility of a severe reaction to any study drug.
At some sites, other treatments may also be assessed. Please ask your hospital doctor if you would like more information. Once you have been included in the study, you and your doctors will know which treatment the computer has allocated for you. Your doctors will be aware of whether there are any particular side effects that they should look out for.
Women who are pregnant may be included, however, the effect of some of the treatments on unborn babies is uncertain. Pregnant women will not receive baricitinib or empagliflozin as they may be harmful in pregnancy or when breast-feeding. The other treatments have previously been used in pregnancy for other medical conditions without safety concerns being raised.
If you or your doctor want to stop the study treatment before the course has been completed, then you are free to do so. If you decide that you do not wish any more information to be collected about you, you are free to say so (although de-identified information that has been collected up to that point will continue to be analysed by the research team).
All information about you and your health will be kept private. The only people allowed to look at the information will be the doctors who are running the study, the staff at the study coordinating centre, and the regulatory authorities who check that the study is being carried out correctly. A privacy notice is on the study website.
Joining the study is voluntary. Your decision whether to take part will not affect the care you receive at this hospital.
All trial treatments will be free. Neither you nor your medical staff will be paid for your participation in this study.
The study is funded by UK Research and Innovation and the National Institute for Health Research, not the makers of any of the study treatments (who may provide the treatment free of charge to the trial). If we find out any new information that might affect your decision to stay in the study, we will give it to you. The University of Oxford, 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. NHS indemnity operates in respect of the clinical treatment that is provided.
If your study team have requested you consider participating in the assessment of dimethyl fumarate (UK only) please read the next page. Otherwise you may stop reading here.
Who is responsible for your data?
The data controller for this trial is the Sponsoring organisation, University of Oxford.
Personal data we collect about you
Staff within the NHS will collect information from you and your medical records for this research. The Central Coordinating Office based in the Nuffield Department of Population Health, University of Oxford will use your name and NHS number (or CHI number in Scotland) to make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. In addition to this, we will seek information from Health Registries or NHS bodies such as NHS Digital about care provided during your admission with Covid-19 (e.g. duration of admission, ventilation) your long-term health status (e.g. reasons for any future hospital admissions). To do this, we will provide your details to the Health Registry or NHS bodies to link the data but this will be done in a secure and confidential manner. The information received from the Health Registry or NHS bodies will be imported into a database held securely by the University of Oxford and used solely for research purposes.
Individuals from the Sponsoring Organisation and regulatory organisations may look at your medical and research records to check the accuracy of the research data. The only people at the Sponsor who will have access to information that identifies you will be people involved in the processes of carrying out the study follow-up or auditing the data collection process. The people who analyse the information will not be able to identify you and will not be able to find out your name, address, NHS number or your contact details.
How we use your personal data
As a publicly funded organisation, we have to ensure that it is in the public interest when we use personally identifiable information from people who have agreed to take part in research. This provides the legal basis for our use of your data; GDPR Article 6(1)(e) and Article 9(2) (j). This means that when you agree to take part in a research study, we will use your data (including your health data) in the ways needed to conduct and analyse the research study. Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. To ensure we carry out the research to the highest standards we comply with the Clinical Trials Regulation 536/2014 and the UK Policy Framework for Health and Social Care Research.
We want to keep you informed about the trial results and progress. To do this we will send you letters by post. If you live in England or Wales, these letters will be sent by NHS Digital on our behalf. In order to write to you, NHS Digital will provide your name and address to APS Group who are a UK-based secure communications provider (used by the NHS for other mailings). If you live in Scotland these letters will be sent by the Health Informatics Centre (HIC) at the University of Dundee on our behalf. In order to write to you, HIC will provide your name and address to DocMail who are a UK-based secure communications provider (used by the NHS for other mailings). If you live in Northern Ireland, these letters will be sent by your hospital. If you would like to receive communications from us by email instead, you can ‘opt in’ to email communications by completing this form. You can opt out of these communications at any time by letter, phone or email (details below).
How long we keep your data
The Sponsor will keep your direct identifiers (eg name) for up to one year after the study has finished, unless you are under 18 in which case we have to keep it until you are 21 because of the statute of limitations. Your other personal data will be retained for at least 25 years after the end of the study, in line with relevant legislation. Since the study will continue long-term follow up for 10 years after the initial treatment phase to assess the long-term effects of the treatments being tested, your direct identifiers will be stored until at least 2031 and your other personal data will be stored until at least 2055. At the end of this retention period, your personal data will either be deleted or rendered anonymous (non-identifiable).
We may need to retain personal data for longer if it is necessary to fulfil our purposes, including any relating to legal, accounting, or reporting requirements. We may also retain personal data for further research for which a legal basis exists. This will always be done in accordance with data protection laws.
General information about how long different types of information are retained by the University can be found in the University’s Policy on the Management of Research Data and Records, available via https://researchdata.ox.ac.uk/university-of-oxford-policy-on-the-management-of-data-supporting-research-outputs/
How we protect your data
We protect your personal data against unauthorised access, unlawful use, accidental loss, corruption or destruction.
We use technical measures such as encryption and password protection to protect your data and the systems they are held in. We also use operational measures to protect the data, for example by limiting the number of people who have access to the databases in which your data is held and using unique reference numbers to identify participants rather than names wherever possible.
We keep these security measures under review and refer to University Security Policies to keep up to date with current good practice.
Sharing your data
Your personal data which are collected and managed by the Sponsor will be used only to allow us to carry out the follow-up of this trial, including linkage with Health Registries or NHS bodies such as NHS Digital. Data from which you cannot be identified may be shared with other research groups who are doing similar research (including the University of Bristol, who are assisting the trial by providing an independent analysis of the trial database, as well as commercial companies and transfer outside the EU). This ‘de-identified’ information will not identify you and will not be combined with other information in a way that could identify you. The information will only be used for the purpose of health and care research, and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance.
Under the General Data Protection Regulation (GDPR), which came into effect on 25 May 2018, you have the following rights in relation to the information that we hold about you (your ‘personal data’):
- The right to request access to your data (commonly known as a "subject access request"). This enables you to receive a copy of your data and to check that we are lawfully processing it.
- The right to request correction of your data. This enables you to ask us to correct any incomplete or inaccurate information we hold about you.
- The right to request erasure of your data. This enables you to ask us to delete or remove your data in certain circumstances for example, if you consider that there is no good reason for us continuing to process it. You also have the right to ask us to delete or remove your data where you have exercised your right to object to processing (see below).
- The right to object to the processing of your data, where we are processing it to meet our public tasks or legitimate interests (or the legitimate interests of a third party) and there is something about your particular situation which makes you want to object to processing on this ground. You also have the right to object where we are processing your data for direct marketing purposes.
- The right to request that the processing of your data is restricted. This enables you to ask us to suspend the processing of your data, for example, if you want us to establish its accuracy or the reason for processing it.
- The right to access, change or move your data. Depending on the circumstances, we may have grounds for not complying with your request, for example, where we consider that deleting your information would seriously harm the research or where we need to process your data for the performance of a task in the public interest.
If you wish to exercise any of these rights, please contact the trial at firstname.lastname@example.org.
If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible. For further information, see: https://compliance.admin.ox.ac.uk/individual-rights
If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officer, email@example.com, who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO) by visiting https://ico.org.uk/make-a-complaint/ or by calling their helpline on 0303 123 1113.
If you would like to contact us directly for more information about how we process and protect data collected for research, please email: firstname.lastname@example.org. If you prefer you can call the study team on 0800 138 5451 or write to: RECOVERY Central Coordinating Office, Richard Doll Building, Old Road Campus, Roosevelt Drive, Oxford OX3 7LF
Dimethyl fumarate is a treatment currently used for multiple sclerosis and psoriasis (a skin condition) which might prevent your immune system from over-reacting to COVID-19, but we do not know for sure whether to assess it in a large group of participants yet. We wish to understand the detailed effects of dimethyl fumarate on people with COVID-19 among about 400 people by conducting some extra tests (see below). The results of these will help us decide whether to continue and enrol several thousand people into an assessment of the drug.
Dimethyl fumarate sometimes causes ‘flushing’ (an unpleasant but not dangerous experience of redness and warmth especially in the face, sometimes associated with itching) and tummy upset. Blood test abnormalities are possible and you will be monitored for these. There is also the unlikely possibility of a severe reaction to any study drug. The effects on pregnant women and breast-fed babies are uncertain so such women should not participate in this part of the study.
We would like to measure how well your lungs are getting oxygen into your blood and whether dimethyl fumarate improves this. We would do this on four occasions over the next 10 days (or until you go home if sooner). This will involve measuring your blood oxygen levels (with a clothes peg-like device on your finger, toe or ear) while the amount of any supplemental oxygen you receive is slowly reduced. If you feel unwell at any time during this measurement, it would be stopped and your oxygen supply returned to normal. It will take up to about 30 minutes each time.
We will also assess the severity of your disease on a daily basis (just by reviewing your medical records) and ask you how well you are tolerating the dimethyl fumarate and if you have had any side-effects.
We will also collect the results of some blood tests that you may have done as part of your routine care. If they are not done as part of your routine care, it would require about 3 mL of blood to be taken on one or two occasions. Once analysed at your hospital laboratory they would be destroyed.
If you or your doctor want to stop the study treatment or your involvement in this part of the study before the course has been completed, then you are free to do so.
No. Joining this part of the study is voluntary. You can still join the rest of the study without participating in this part.