We would like to invite you to take part in a study about treatments for COVID-19 infection called PRINCIPLE. Before you decide if you would like to take part it is important that you understand why we are doing this research and what it would involve for you. Please take time to read the information carefully and decide if you wish to take part. You may like to talk to others, friends or family members about the trial. Please ask if there is anything that is not clear or if you would like more information. EudraCT number:2020-001209-22
The PRINCIPLE trial aims to find treatments for COVID-19 for older people. We want to find medicines that can help people with COVID-19 symptoms get better quickly and stop them needing to go to hospital. The trial is recruiting participants through this website
– About the trial
– Who can take part
– What the trial involves
– Why take part
Coronavirus disease 2019 (COVID-19) can be more severe in older people, and people with underlying health conditions. At the moment, there are no specific treatments that we know definitely work against COVID-19. We urgently need research to find medicines that help people get better quickly and stop them needing to go to hospital.
About the trial The PRINCIPLE trial is a national priority trial to find treatments for COVID-19. It is now a country-wide trial, and the only national priority platform trial in primary care. The trial is being run by the University of Oxford and is funded by UK Research and Innovation and the the Department for Health and Social Care through the National Institute for Health Research.
Aim of this trial We aim to find treatments for COVID-19 for people in the community who are at higher risk of complications. We want to find medicines that can help people get better quickly and stop them needing to go to hospital. In the first instance, we are testing a drug called hydroxychloroquine. This is a drug that is well known and has been used for many years around the world for conditions such as malaria and arthritis, but is not currently used to treat COVID-19.
Who can take part Participation is entirely voluntary. It is up to you to decide whether to take part in the trial or not. The decision to not take part will not affect the standard of care you receive from the NHS in any way, now or in the future. The trial is open to people aged 65 or over even without other illnesses who have symptoms of COVID-19. It is also open to those aged 50 to 64 who are experiencing symptoms that are likely to be caused by a COVID-19 infection and have at least one of the following conditions:
A known weakened immune system because of a serious illness or medication (e.g. chemotherapy);
Known heart disease or high blood pressure;
Known asthma or lung disease;
Known diabetes not treated with insulin;
Known mild hepatic impairment (liver disease);
Have previously had a stroke or have known neurological problems.
Symptoms of COVID-19: a new, continuous cough and/or a high temperature. These symptoms need to have been experienced for fewer than 15 days
What does the trial involve? Briefly, participants will need to answer some questions online or on the telephone (0800 138 0880) to check they are suitable, and provide consent. They will be able to nominate a ‘study partner’ (family, friend, carer) to help them with the study.
Their GP, or a study nurse or doctor, will also check their medical notes to make sure it is safe for them to be in the study.
They will either receive usual care, or usual care and a study drug which will be delivered from their GP, or directly from the research team. All study drugs are already widely used in the NHS and have been approved as safe for use in this study. The study will use a computer programme to decide by chance whether they get the drug or not.
They will have a swab done to test for COVID-19, if swabs are available. If they can access the internet, for the next 28 days we would like them to complete an online diary of their symptoms and medical care they have received. If they can’t access the internet, the trial team can phone them every one to two weeks to get this information
Why take part By taking part in this trial, you will be contributing towards the understanding of how we can treat COVID-19 and how the symptoms progress. This may or may not help to reduce the duration and severity of symptoms when people fall ill. We also hope to reduce the burden on the NHS.
Further information at www.principletrial.org