Start Date

2021

Status

Recruiting

Principal Investigator

Dr Oliver Koch

Main Research Site

RIE/WGH

In early 2021, when the trial commenced, there were no treatments being assessed in randomised controlled trials targeting the post-hospital convalescent phase of COVID-19. Long-term outcomes for COVID-19 are currently unclear, but early data suggests a significant burden of mortality and morbidity. In this situation, even treatments with only a moderate impact on survival or on hospital resource use are worthwhile. Therefore, the focus of HEAL-COVID is the impact of candidate treatments on mortality and the need for re-hospitalisation.

The primary objective of HEAL-COVID is to determine whether interventions in the post-hospital (convalescent) phase of COVID-19 improve longer-term mortality/morbidity outcomes.

The secondary objectives of HEAL-COVID are to evaluate treatment-specific and patient-reported outcomes of COVID-19 and their response to intervention. An additional objective is to estimate the cost-effectiveness of treatments.

HEAL-COVID is designed as an adaptive randomised, open label multicentre superiority platform trial. The study is designed using a platform structure that allows multiple different treatments to be evaluated simultaneously and new treatments can be added to the platform.

The currently active arms of the study, that participants can be randomised to are:

  • Apixaban, an anti-coagulant or “blood thinner”, twice a day for 2 weeks or
  • 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.
Main Funding Body