Thank you for your interest in the RECOVERY Trial. This trial is recruiting people who have been admitted to hospital with 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.
There are no drugs of proven value against COVID-19 although there are several 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. Some are tablets and some are injections. 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, are: Lopinavir-Ritonavir (commonly used to treat HIV); corticosteroids (a type of steroid, which are used in a range of conditions typically to reduce inflammation [the precise type differing in pregnant women and other participants, but all in common use]); hydroxychloroquine (a treatment for malaria); or azithromycin (a commonly-used antibiotic). For patients whose condition is more severe, tocilizumab (a treatment for rheumatoid arthritis) is also an option. 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.
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. 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. It may also include an additional treatment, which might be given by mouth, injection or inhalation. Neither you nor your doctors can choose which of these options you will be allocated. If your condition is severe or should deteriorate, then your doctors may choose to enter you into a second phase in which the computer will allocate you at random again to one of the further possible treatment options (in addition to your previous study treatment and always including usual standard of care for your hospital).
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. In some instances, 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.
Apart from the known side effects of these treatments (which may include tummy upset, ‘flu-like symptoms, and blood test abnormalities), there is the unlikely possibility of a severe reaction to a study drug. Although Tocilizumab has been very rarely associated with liver damage in prolonged use this is not expected to be a problem with the short-term administration in this study. Women who are pregnant may be included, however, the effect of some of the treatments on unborn babies is uncertain - although all the treatments have previously been used in pregnancy for other medical conditions without safety concerns being raised. If you do receive treatment and are not already pregnant, as a precaution, we advise that you should not get pregnant within 3 months of the completion of the trial treatment(s). 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.
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.
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. 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.
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, address, NHS number and contact details to contact you about the research study, and 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 NHS Digital and central NHS registries about your long-term health status. To do this, we will provide your details to NHS digital to conduct the ‘data linkage’ but this will be done in a secure and confidential manner.The information received from NHS Digital will be imported into a database held securely by the University of Oxford and used solely for academic research purposes.
Depending on the intervention allocated as part of the trial, identifiable personal data may also need to be shared with other NHS organisations, such as NHS Blood & Transplant, to ensure the appropriate type of treatment is provided. This will also be done using secure means. NHS Blood & Transplant have a privacy notice available at https://www.nhsbt.nhs.uk/privacy/.
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 process of contacting you to carry out the study follow-up, sending you a copy of the results 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). This means that when you agree to take part in a research study, we will use your 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 Directive 2001/20/EC and the UK Policy Framework for Health and Social Care Research.
How long we keep your data
The Sponsor will keep identifiable information about you 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. De-identified data will be retained for up to 25 years, to allow for potential marketing authorisation applications and in line with appropriate legislation.
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 NHS digital. Data from which you cannot be identified may be shared with other research groups who are doing similar research. 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.
Request the transfer of your data to another party
Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. 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 1231113.
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