National drug trial to prevent deaths after Covid patients leave hospital


25-03-2021
Study lead Dr Charlotte Summers

A UK-wide study is being launched to reduce the number of people who die in the months following a stay in hospital with Covid-19.

The clinical trial - named HEAL-COVID - also aims to cut the number patients being readmitted to hospital with complications as a result of having Covid.

Data from the Office for National Statistics (ONS) 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.

HEAL-COVID stands for Helping to Alleviate the Longer-term consequences of Covid-19 and is funded by the National Institute for Health Research (NIHR) and the Cambridge NIHR Biomedical Research Centre.  It will test a number of safe, existing drugs on patients across the UK in order to find effective treatments.  

Study lead Dr Charlotte Summers, from the University of Cambridge and Addenbrooke's Hospital (pictured), said: "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.

"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."

The trial is being led by Cambridge University Hospitals NHS Foundation Trust (CUH) and University of Cambridge, in collaboration with Liverpool Clinical Trials Centre (University of Liverpool) and Aparito Limited.

HEAL-COVID will enrol patients when they are discharged from hospital, following their first admission for Covid-19.  They will be randomised and given one of two drugs – apixaban and atorvastatin - and their progress tracked. It's hoped a third drug will be introduced to the trial on the recommendation of the UK COVID Therapeutic Advisory Panel (UK-CTAP) in the coming weeks.

Prof Carrol Gamble, Director of the Liverpool Clinical Trials Centre, said: “This is an exciting opportunity to help people in the post-acute phase of Covid-19. 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.”

NHS medical director, Professor Stephen Powis, said: “The NHS led the world in research identifying dexamethasone as the first treatment in the world for Covid-19 and this latest trial could help discover new treatments for the after-effects of Covid, helping to rapidly get world-leading therapies to our patients.

“Long Covid can have a significant impact on someone’s quality of life, which is exactly why in addition to funding research into the condition, the NHS has invested millions into opening dozens of dedicated clinics to help people get back to good health. “

Hospital readmissions and deaths

Latest figures show more than 450,000 people have been admitted to UK hospitals with Covid-19.

Recent data from the Office for National Statistics tracked the outcomes of 47,780 people who were discharged after a hospital admission for Covid-19.  Analysis of the data found:

  • Half the participants were of working age (average age was 64.5 years)

  • 29.3% of them were readmitted to hospital within about 6 months

  • 12.3% died within about 6 months of hospital discharge

(Epidemiology of post-COVID syndrome following hospitalisation with coronavirus: a retrospective cohort study; Ayoubkhani D, Kamlesh Khunti, Nafilyan V, Maddox T, Humberstone B, Diamond I, Banerjee A. medRxiv 2021.01.15.21249885; doi:https://doi.org/10.1101/2021.01.15.21249885)

This analysis is reflected in data from other health systems, such as the United States (Donnelly JP et al, Readmission and Death After Initial Hospital Discharge Among Patients With Covid-19 in a Large Multihospital System, JAMA 2021; 325:304-6).

The treatments

Apixaban is an oral anticoagulant drug that is used to reduce the risk of blood clots forming.

Atorvastatin is a widely used lipid lowering drug (‘a statin’) that also acts on other mechanisms of disease that are thought to be important in Covid-19.

Technology

The Innovative technology needed to monitor patients once they have been discharged will be provided by Aparito Limited.

Aparito provides innovative, patient-centric drug development solutions, integrating specialist clinical and regulatory knowledge with the technology to gather highly relevant patient-generated data outside of the hospital setting, to streamline the drug development process.

Their software platform Atom5™ is disease agnostic, multi-lingual and highly configurable. Patients access a study specific app on their own smartphone / tablets (iOS or Android) which alert patients when it’s time to answer Patient Reported Outcomes according to the study protocol.

 

Cambridge University Hospitals is one of the largest and best known trusts in the country. As the local hospital for our community we deliver care through Addenbrooke’s and the Rosie hospitals.

Cambridge University Hospitals NHS Foundation Trust