For site staff

You may be invited to take part in this research study because you have been feeling unwell with symptoms caused by coronavirus. Also, you have been feeling so unwell that your health needs to be looked after at the hospital. The virus, SARS-CoV-2 (severe acute respiratory syndrome-coronavirus 2) causes the condition COVID-19. At the moment, there are not any fully approved medicines to treat COVID-19. This research is being done to test whether medicines which we think may work against SARS-CoV-2 or the illness it generates might be able to help people with COVID-19.

At your hospital and at other hospitals across the UK, universities, companies making medicines, and the UK Government are working together to see if existing treatments for other conditions or diseases may be used to treat people with COVID-19. To do this, several treatments will be tested, one at a time, in people with COVID-19. Some treatments act directly against the virus when it gets into the body. These types of treatments are called anti-virals. They work by stopping the virus from making extra copies of itself. This may help stop the spread of the infection, both within the body and to other people. Other treatments help the body’s immune system (natural defence against viral infections) to work better. These types of treatments are called immunomodulatory drugs. As each existing treatment is tested in people with COVID-19, a group of doctors and researchers will look at the results to see whether it works and how safe it is. The effect on COVID-19 symptoms in patients receiving test treatments plus the standard of care will be compared with patients who only receive the standard of care. By ‘standard of care’ we mean the care recommended under NHS guidelines at the time of treatment during an ACCORD trial. These guidelines may change during the course of ACCORD as we understand COVID-19 better. Each drug will be tested in 2 stages: Stage 1: will test how safe the drug is when given with standard of care. It will also look at whether the drug works to improve symptoms of COVID-19. The information gathered from Stage 1 will be used to see if the drug should continue to be tested in Stage 2 of the study. Stage 2: will continue to look at whether the drug works when given with standard of care and how safe it is. It will further look at the effects of the drug on the disease, such as collecting information on whether symptoms have improved, if care in the intensive care unit is needed, and survival and health status after recovery. In Stage 2, the study doctor and researchers hope to confirm that the drug works to lessen the symptoms of COVID-19 or shorten the time people with COVID-19 are ill.

ACCORD is led by Professor Tom Wilkinson from NIHR Southampton Biomedical Research Centre, professor of respiratory medicine at the University of Southampton and honorary NHS consultant physician at University Hospital Southa mpton. The steering committee includes clinical and scientific experts, representatives of the trial sponsor and the UKRI, and representatives from the trial sites and delivery group. ACCORD has been made possible by partnership working between the Government Scientific Office, the NIHR’s Biomedical Research Centres and Clinical Research Facilities, and expert centres in Northern Ireland, Scotland and Wales, clinical research company IQVIA and biopharmaceutical companies. It is run in collaboration with other major trial in the UK.

You may be asked to consider participating in this study if you: Are 18 years of age or older Have tested positive for the SARS-CoV-2 infection Are feeling unwell and need to be admitted to the hospital with COVID-19 Are being treated with: Supportive care, but you are able to breathe without the need of additional oxygen You need help breathing by being treated with additional oxygen - you are receiving extra oxygen either through a face mask or by tube with prongs in the nose (called a nasal cannula) Require non-invasive ventilation devices - this means that you have more difficulty getting air in when you breathe, so a tight fitting mask on your face or nose is being used. The extra oxygen is being given to you at pressure to help you breathe by keeping your airway open. This is similar to the devices that some people who snore may use at night.

You will need to sign the consent form. The study doctor will then collect information about you and your health, and you will have some tests and assessments to check that the study is right for you. You will then be randomly assigned (by chance) to receive either the study drug with the usual standard of care, or only the usual standard of care. You and the study doctor will know if you receive one of the trial drugs or not. You can expect to be in the study for about 90 days (3 months). Treatment and assessments will continue for 29 days or until you are considered well enough to leave the hospital. After the treatment period, you may be asked to return to the hospital on Day 60 (after 2 months) and Day 90 (after 3 months). If this is not possible home visits may be arranged. This is to check how you are doing and if you have had any side effects from the study drug.

No – participation is entirely voluntary, and you can stop taking part in the study at any time without giving any reason. This will not affect your future treatment or your relationship with your study doctor. If you stop taking part, please tell your study doctor immediately. If you have already been released from the hospital, you may be asked to return to the study centre for an end-of-study assessment. You may also be asked for permission to be contacted at a later date by your doctor to collect minimum additional data about your condition. If, during the study, you become unable to provide consent, the consent you provided before the study would still be applicable and you would continue in the study, unless the study doctor does not think this is best for you.

It is possible that the symptoms of your condition will not improve during the study or may even worsen. The study drug may also involve risks to your future health that we currently don’t know about.

The study doctor and research team will collect, record and use personal information about you for the study purposes. The Sponsor (University Hospital Southampton NHS Foundation Trust) estimates that your personal information will be stored for approximately 15 years after the end of this study. Any information about you that is collected during this study will remain confidential.

If you have any questions about your participation in the study, please contact your study doctor or research team.