TACTIC, as the trial is known, will test whether re-purposing existing drugs, which target the body’s own immune response, can prevent people suffering severe organ failure or death. The trial is part of the coordinated national approach by the UK Government to support the early phase development of potential new treatments for COVID-19.
For the majority of people with Covid-19, the infection causes only mild symptoms, including a fever and cough. However, around 15% of patients develop severe disease, including serious damage to the lungs and multiple organ failure, and about two percent die.
The serious symptoms appear to be mostly caused by the body’s own immune system responding to the presence of infected cells and ‘over-reacting’, destroying healthy cells as well as virus-infected ones.
Two drugs will initially be tested through TACTIC on patients at a network of hospitals across the UK, including Guy’s and St Thomas’ NHS Foundation Trust, King’s College Hospital and Cambridge University Hospitals NHS Foundation Trust (CUH).
The first patient was recruited onto the study at Addenbrooke’s hospital in Cambridge on Friday 08 May.
The two drugs, Ravulizumab and Baricitinib, have been carefully selected by a consortium of doctors and scientists with expertise in treating immune-response diseases. They are both thought to have a high chance of reducing the sometimes fatal over-reaction of the immune system seen in very sick patients with Covid-19.
This study is one of a number of COVID-19 studies that have been given urgent public health research status by the Department of Health and Social Care. It is supported by the National Institute for Health Research (NIHR) Biomedical Research Centres at Cambridge and Guy’s and St Thomas’ and UK Research and Innovation; the drug manufacturers , Lilly and Alexion, have each supplied the drug for up to 469 subjects as well as contributing up to £200,000 in running costs for the project.
If the trial demonstrates that a drug is effective, it will be quickly moved into NHS care pathways, to treat the patients with severe Covid-19 related disease. Similarly, if the trial reveals that a drug is not effective, it can be quickly removed so that other options can be tested.
UK Research and Innovation Chief Executive, Professor Sir Mark Walport, said: “By supporting the rapid progress of these re-purposed drugs into early clinical trials we will test whether they can prevent the development of severe COVID-19 symptoms. Trialling drugs that have the potential to suppress the severe inflammation caused by an over-reaction of the immune system is an important part of tackling the COVID pandemic.”
Dr James Galloway, Senior Lecturer in Rheumatology at King’s College London, and a Co-Investigator on the TACTIC trial, said: “By testing existing drugs that we think have the best chance of working against Covid-19, we hope that we can find proven ways to treat the disease. Identifying the high risk patients taking part in this research will be key, and we’re incredibly grateful to the patients who have been so willing to take part, and their families.”