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. 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).
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).
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, authorised staff at Oxford University and your hospital, 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 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.
