COVID-19 is a disease caused by a virus called SARS-CoV-2, which affects not just the lungs but other organs like the heart, kidneys and blood vessels too. Recently, we have become aware of people who have been unwell with COVID-19 developing new or worsened symptoms after being discharged from hospital – this is often called “Long COVID”. Long COVID is thought to represent a mix of conditions and around 1 in 5 patients with COVID-19 develop symptoms currently associated with the term Long COVID.

This is a serious group of conditions that can result in death and disability for some people.

Long COVID is not well understood. We do not yet know which treatments are best to prevent and treat it. There are several commonly used medicines that might help people with Long COVID, but we do not know yet how well they work for patients who have had COVID-19, or which treatments are the best. The HEAL COVID study was set up to look at different treatments that work on the complications and symptoms seen in patients with Long COVID. The results from this study will be used to help us improve treatments and care for patients with long-term effects of COVID-19.

You have been approached to take part in this study because you have been diagnosed with COVID-19 and are due to be discharged from hospital in the next few days.

There is potential that the treatment you are given as part of the study may improve your symptoms and help you recover from your COVID-19 illness more quickly. Though these medications are well-established treatments with a known profile of safety, like most medication, they also have potential side effects.

If you are given Atorvastatin, some common side-effects you might experience are:

• Headaches
• Cold-like symptoms, including sore throat
• Feeling sick (nausea)
• Flatulence, diarrhoea or constipation
• Indigestion
• High blood sugar
• Nosebleeds
• Sore muscles or muscle spasms, sore or swollen joints, or back pain
• Abnormal liver function test results

Statins can increase glucose levels, and if you have concerns or are at increased risk of diabetes, please consult your doctor. Women of childbearing potential will also need to use appropriate contraception while taking Atorvastatin.

We will stop your medication if the study shows that there is no evidence of its benefit over standard care. If this happens, you will be offered standard care.

You can contact us at any time if you wish to stop taking part in the study. You will still receive the standard care and the follow up usually offered by your hospital. With your permission, we would like to continue collecting information about your health from routine healthcare records.

In some cases, we may need to continue to collect limited information about any side-effects of the study treatment you may experience. We will only do this where we are required to do so by law.

Sometimes during the course of a research project, important new information becomes available about the treatments that are being studied. If this happens, your doctor or nurse will tell you about it and discuss with you whether you want to or should continue in the study. If the study is stopped for any other reason you will be told why and your continuing care will be arranged.

At the end of the study your treatment will return to standard care. If you are still experiencing symptoms your healthcare team will arrange appropriate ongoing care for you.

It is intended that the results of the study will be presented at conferences and published in medical journals, so that we can explain to the medical community and public what our research results have shown. Confidentiality will be ensured at all times and you will not be identified in any publication. We will keep all information from the study for 10 years.

Yes. The only people that have access to your data are those that need it for the conduct of the study. This includes the study doctors and nurses, the central trial team, Aparito (who provide the ATOM5 study app), inspectors or auditors on behalf of the Sponsor organisations and the regulatory authorities. With your permission, we will let your GP know that you are taking part in this research study.

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.

In order to access your routine healthcare data, Liverpool Clinical Trials Centre (LCTC) will securely send your date of birth and NHS/CHI/Health & Social Care number to NHS Digital, or the equivalent organisations in Scotland, Wales and Northern Ireland who look after NHS data records. We plan to ask for your data for 12 months from the day you enter the study, but this may be extended in future to follow-up your long term health status. The NHS Digital (or equivalent) data returned to LCTC will be shared securely with Bangor University, who are doing some of the study analysis. Researchers at Bangor University will not receive your personal details and will not be able to identify you.
Further information about how we use your data and keep it safe can be found on the HEAL-COVID website, heal-covid.net.

Cambridge University Hospitals NHS Foundation Trust and The University of Cambridge jointly Sponsor this study and are responsible for managing it. They are based in United Kingdom. They have asked that the day to day running of the study is carried out by a team based at the Liverpool Clinical Trials Centre (LCTC, part of the University of Liverpool). The central trial team are researchers from the University of Cambridge, LCTC and Bangor University.

The study has been reviewed by the Medicines and Healthcare Products Regulatory Agency, the Health Research Authority and the National Research Ethics Service Committee to make sure that the study is scientifically and ethically acceptable. This study is funded by the National Institute for Health Research (NIHR).

Your doctor will not receive any payment for including you in this study.

If you agree to take part in this study, you will have the option to allow future research at other organisations using your data collected as part of this study. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health. and Social Care Research, or equivalent standards.

Any complaint about the way you have been dealt with during the study or any possible harm you might suffer will be addressed. If you have a concern about any aspect of this study, you should ask to speak with one of your research team who will do their best to answer your questions.

If you remain unhappy and wish to complain formally, you can do this by contacting local NHS Patient Advice and Liaison Service (PALS) or equivalent. Members of your local hospital team should be able to provide this information to you. Every care will be taken in the course of this clinical study. However, in the unlikely event that you are harmed by taking part in this research project, and this is due to someone’s negligence, then you may have grounds for a legal action for compensation against the NHS Trust where you are being treated but you may have to pay for your legal costs. The normal National Health Service complaints procedures should be available to you.
Cambridge University Hospitals NHS Foundation Trust, as a member of the NHS Clinical Negligence Scheme for Trusts, will accept full financial liability for harm caused to participants in the clinical trial caused through the negligence of its employees and honorary contract holders.

The University of Cambridge will arrange insurance for negligent harm caused as a result of protocol design and for non-negligent harm arising through participation in the clinical trial. If you believe you have been harmed by taking part in this study, you should contact the research team at your hospital in the first instance, via the contact details on page 1 of this information sheet.

Your hospital where you receive your treatment has a duty of care to you whether or not you agree to participate in the study and the study Sponsor accepts no liability for negligence on the part of your hospital’s employees.
If you have concerns about your well-being you should speak to a member of your clinical team before you leave hospital. Once home, contact your GP or call 111. Resources for support and advice following your COVID-19 illness can be found on our website (heal-covid.net).

If you are asked to take Atorvastatin, you will be given repeat prescriptions for this by your GP, because the treatment lasts for longer than Apixaban. If you usually pay for your prescriptions, you will be exempt from paying for your trial treatment.

There will not be any other costs incurred to you by taking part in the HEAL-COVID study.

Please contact your GP to request a new prescription.

Your GP has been informed of your participation in the trial. If you have been prescribed new medication and are unsure of whether this can be taken alongside your trial treatment, please contact your GP to discuss this.

If you have a new phone and wish to install the Atom5 app to continue completing follow-up surveys, please click here to register a new device.

If you are not able to re-install the Atom5 app and wish to continue to complete the questionnaires by telephone, please contact the central research team on trial.team@heal-covid.net

For advice about your COVID-19 recovery and more information about Long COVID, please visit our patient resources section.