In an effort to reduce the number of deaths and readmissions of patients who have previously been hospitalised with Covid-19, the UK is gearing up to launch national drug trial HEAL-COVID.
Alarming data from the UK Office for National Statistics suggests that 29% of patients who are hospitalised due to Covid-19 are readmitted within six months, and more than 12% die within the same period.
The HEAL-COVID trial aims to find drugs to reduce deaths and hospital readmissions among patients who are recovering after being treated for Covid-19.
The study is funded by the National Institute for Health Research (NIHR) and the NIHR Cambridge Biomedical Research Centre, and is being led by Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge, in collaboration with Liverpool Clinical Trials Centre at the University of Liverpool and Wrexham-based clinical trial technology firm Aparito.
HEAL-COVID (short for Helping to Alleviate the Longer-term consequences of COVID-19) will test a selection of safe, existing drugs already on the market on patients across the UK in order to find effective treatments.
“Having survived the trauma of being hospitalised with Covid-19, far too many patients find themselves back in hospital with new or long-term complications,” said study lead from the University of Cambridge and Addenbrooke’s Hospital Dr Charlotte Summers.
“Unfortunately, many go on to die in the months after being discharged. This trial is the first of its kind to look at what drugs we could use to reduce the devastating impact on patients.”
HEAL-COVID will enrol patients who are fresh out of hospital, following their first admission for Covid-19.
The patients will be randomised to receive one of two common drugs – blood thinner apixaban and atorvastatin, a statin used in the treatment of cardiovascular disease, among other indications – and their progress will be tracked to see if they improve longer-term outcomes.
“Apixaban is a clot-busting drug and we know people with coronavirus infection are at an increased risk of getting clots in their lungs and their legs, so this is to try and target that in the post-hospital phase,” Summers told the BBC.
“Atorvastatin is a statin which is a good anti-inflammatory and probably targets some of the disease processes that are ongoing in people with Covid.”
Importantly both of these drugs are “relatively cheap, easy to take as they’re tablets and they’re widely available,” Summers added.
The trial leaders anticipate that a third, undisclosed drug will be introduced to the study on the recommendation of the UK COVID Therapeutic Advisory Panel in the coming weeks.
“This is an exciting opportunity to help people in the post-acute phase of Covid-19,” said Liverpool Clinical Trials Centre director Professor Carrol Gamble.
“The trial is designed to allow us to remove or add in treatment options in response to patient outcomes. Every effort has been made to design the trial to minimise burden on NHS staff and patients and represents a true team approach to science.”
With the Covid-19 pandemic raging for more than a year and over four million total confirmed cases in the UK, the effects of ‘long Covid’ or post-Covid-19 syndrome are becoming more apparent and of increasing concern.
The list of persisting and new symptoms reported by patients is extensive and ever-growing. They include chronic cough, shortness of breath, chest tightness, cognitive dysfunction, and extreme fatigue.
In a survey by the UK Government’s Office for National Statistics in November 2020, around one in five people who tested positive for Covid-19 had symptoms that lasted for five weeks or longer, and one in ten people had symptoms that lasted for 12 weeks or longer. This equates to an estimated 186,000 people in England who had symptoms continuing between five and 12 weeks.
“The UK is a world-leader in developing life-saving treatments in response to the pandemic and this clinical trial is further evidence of this,” said UK Minister for Innovation Lord Bethell. “It is vital we continue our search for the best treatments for Covid-19, particularly to prevent people developing long-term complications after becoming ill.
“Clinical trials platforms like HEAL are showing how innovative designs can mean we can reach just the right candidates, quickly and emphatically. I am massively grateful to the incredible scientists and clinicians at Cambridge University who are driving forward this life-saving work, which will play a critical role in putting this pandemic behind us.”