For patients
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 or influenza. We hope the video and Frequently Asked Questions on this page address any questions you might have.
Your doctors have found that you have a lung disease called COVID-19 and/or influenza pneumonia (“flu”). COVID-19 is caused by a type of virus called SARS-CoV-2, or coronavirus for short. Influenza pneumonia is caused by a flu virus different to COVID-19. About 19 out of 20 patients who get these viruses 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 has already shown that low doses of a type of steroid, dexamethasone and other treatments reduce the risk of dying for some patients hospitalised with COVID-19. There are several other treatments which may turn out to be helpful (or possibly harmful) when added to the usual standard of care for either COVID-19 or influenza pneumonia. This study aims to find out whether any of these additional treatments are helpful.
This study aims to compare several different treatments that may be useful for patients with COVID-19 and/or influenza pneumonia. 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 help patients recover more effectively than the usual standard of care all patients at your hospital will receive.
The treatments for COVID-19, which may be given in addition to the usual care at your hospital, include a high dose steroid, dexamethasone (if you need help with your breathing), a treatment for diabetes or heart failure called empagliflozin, a synthetic antibody treatment directed against the virus (called sotrovimab) and two antiviral treatments called molnupiravir and Paxlovid.
The treatments for influenza pneumonia, which may be given on top of your usual care, include two anti-viral treatments, oseltamivir and baloxavir and low-dose dexamethasone. At present, we don’t know whether any of these will work. However, the side-effects are already well-known from other uses and so your doctor will be able to monitor you appropriately.
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 and/or influenza pneumonia confirmed by a laboratory test, and are in hospital. Patients will not be included if the attending doctor thinks none of the study treatments are suitable for them. Patients may be included if they have previously been recruited into RECOVERY >6 months ago (although not into the same comparison more than once).
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. If you are a woman of child-bearing potential, you will have a pregnancy test. If you might receive sotrovimab, molnupiravir or Paxlovid a blood sample will be sent to a central laboratory for measurement of coronavirus and antibodies against it, and a nasal swab may be collected now and twice more in the next 5 days. If you have ‘flu a nasal swab will be collected now and once more in 5 days. The results of all these tests will not be available to your medical team because they are for research and are not validated for clinical application, and the samples will be destroyed once testing is complete. If you are discharged before day 5 you will be asked if you would be willing to take a swab sample at home and post it back (free of charge). This is optional.
The computer will then allocate you at random (like rolling a dice) to one (or sometimes more) of the possible treatment options, depending on what illness you have and what your doctors think is suitable. In all cases this will include the usual standard of care for your hospital and it may also include additional treatment, which might be given by mouth or injection. Neither you nor your doctors can choose which of these treatments you will be allocated.
Additional information about your health will be recorded and entered into the study computer. No additional visits will be required after you leave the hospital. Information about your health (before, during, and after the study) may be obtained from medical records or databases (including NHS England, 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 your discharge. For pregnant women we will collect your and your baby’s outcome from the UK Obstetric Surveillance System. 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.
- Dexamethasone may disturb sleep and increase the risk of infections. In people with diabetes it can 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.
- Oseltamivir may cause headache, tummy upset and allergic reactions.
- Baloxavir rarely causes allergic reactions, but has no other known side effects.
- Sotrovimab is given by intravenous infusion and may cause allergic reactions during the infusion, but severe reactions have been rare.
- Molnupiravir may cause dizziness, headache, tummy upset and rashes.
- Paxlovid may cause altered taste and tummy upset. For people given Paxlovid who require steroids an alternative to dexamethasone will be prescribed due to a known interaction between these medications.
There is also the unlikely possibility of a severe reaction to any study drug. 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 taking molnupiravir or Paxlovid should not get pregnant while taking the drug or for 4 days afterwards. Women using the combined oral contraceptive who receive Paxlovid should use either additional barrier contraception or an alternative effective method until after one complete menstrual cycle after leaving hospital. 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 empagliflozin, Paxlovid (in first 12 weeks of pregnancy) or molnupiravir as it may be harmful in pregnancy or when breast-feeding. Dexamethasone and oseltamivir have previously been used in pregnancy for other medical conditions without safety concerns being raised. Baloxavir and sotrovimab (and Paxlovid after 12 weeks of pregnancy) have not been used in pregnant women before but are considered to have an acceptably low level of risk to use in pregnant women in this trial by a national expert panel; your medical team will discuss with you whether you would be willing to receive them.
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).
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. This could include copies of any scans or x-rays you may have had while you were in hospital. These scans would have all your identifiers removed before they are shared. 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 England 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
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 England and Public Health Scotland. If you have also participated in the ISARIC4C study, your data from the RECOVERY trial may be securely transferred to the Scottish National Safe Haven secure environment managed by Public Health Scotland so that the data about you from RECOVERY and ISARIC4C can be analysed together. The RECOVERY_Data Privacy Notice – Version 2.3; 01-Feb-2023 IRAS ID: 281712 REC: 20/EE/0101 3 RECOVERY data about you held in the Scottish National Safe Haven will be accessible only to a small number of researchers who are employed by the University of Oxford, and Public Health Scotland system administrators.
Data from which you cannot be identified (‘de-identified’ information) may be shared with other research groups who are doing similar research or the manufacturers of the treatments tested in RECOVERY (including commercial companies and researchers outside the EU). The companies may provide the data (and/or analyses based on them) to government drug regulatory authorities (e.g. the UK Medicine and Healthcare products Regulatory Agency or the United States Food and Drug Administration) to support their applications for approval of the drug to be used in treatment of patients with COVID-19. Researchers would apply to access data from the RECOVERY trial through the Infectious Diseases Data Observatory (IDDO). Researchers applying to use the data must demonstrate that their research will benefit public health and will only be provided with the data required to answer their specific question. You can see which research groups have made successful applications on the IDDO website.
De-identified scan or x-ray images may be shared with Caristo Diagnostics, a private company who specialise in analysis of images.
The ‘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
Your rights
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 recoverytrial@ndph.ox.ac.uk.
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
Complaints
If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officer, data.protection@admin.ox.ac.uk, 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.
Contact us
If you would like to contact us directly for more information about how we process and protect data collected for research, please email: recoverytrial@ndph.ox.ac.uk. 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
RECOVERY Data Privacy Notice v2.3 (1 Feb 2023)
If you have any questions please speak to your hospital medical team. Further information about the study is available on the study website (www.recoverytrial.net).
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 has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) and by the Cambridge East Research Ethics Committee (Health Research Authority, ref 20/EE/0101). It 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.
