HElping Alleviate the Longer-term consequences of COVID-19 (HEAL-COVID): a national platform trial
COVID-19 is the infectious disease caused by the virus SARS-CoV-2, which spread across the world from December 2019. The effects of COVID-19 in the early stages of illness are now well known, and research projects have identified new treatments to help patients at this early stage. 1 in 10 patients die 3 months after being discharged from hospital. There is also evidence that around 20% of COVID-19 patients develop new or worsened symptoms, often involving their heart, lungs and circulation, after discharge from hospital. These symptoms are often grouped together as part of a syndrome known as “Long COVID”.
Because COVID-19 was a new disease, there was still a lot that we did not know, particularly about the longer term effects. HEAL-COVID is a clinical trial to compare different treatments that could prevent or reduce long term symptoms in COVID-19 patients. The main objective of HEAL-COVID is to determine whether the treatments used improve longer-term outcomes for COVID-19 patients.
We invited patients who had been admitted to hospital with COVID-19 to take part in HEAL-COVID. Patients were asked if they would like to take part shortly before they were discharged home, and were then randomly allocated to receive:
2021-2022: Apixaban, an anticoagulant, twice a day for 2 weeks or the usual standard care offered by their hospital, as appropriate to their symptoms and conditions.
2021–2023: Atorvastatin, a statin with anti-inflammatory properties, once a day for 12 months or the usual standard care offered by their hospital, as appropriate to their symptoms and conditions.
HEAL-COVID participants were also invited to complete follow-up surveys. This was optional. Surveys could be completed via an app on a smartphone or tablet, or over the phone with a Research Nurse. The surveys were sent no more frequently than once a week, and included questions relating to symptoms, quality of life, resource use and experience of participating in research.
While the main objective of the trial is to find out if the treatments used are effective, and help improve care for COVID-19 patients in the future, we will also use data from the study to investigate whether the treatments are cost-effective.