HEAL-COVID trial [COVID-19] [UPH]
Research type
Research Study
Full title
HElping Alleviate the Longer-term consequences of COVID-19(HEAL-COVID): a national platform trial
IRAS ID
294861
Contact name
Charlotte Summers
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust & the University of Cambridge
Eudract number
2021-001187-25
ISRCTN Number
ISRCTN15851697
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
COVID-19 is the disease caused by SARS-CoV-2. Despite unprecedented public health measures, SARS-CoV-2 has rapidly spread across the world. Though much is now known about the virus and the short-term effects of the disease it causes; the longer-term complications associated with COVID-19 are only starting to become apparent. We do not yet have full information on longer-term outlook from COVID-19, but as many as 1 in 4 survivors still experience significant symptoms some weeks after the initial illness and 1 in 10 die within the first 3 months. This study will assess several different treatments that may be of benefit in reducing or preventing the complications that patients with COVID-19 are reporting after their acute illness.
HEAL-COVID is a large platform clinical trial designed to assess whether several different treatments are better than the current “standard of care” (the best available evidence-based treatment). In practice, this means the study will be flexible enough to include new treatments not specified at the start of the trial as our understanding of COVID-19 changes.
Participants will be recruited from hospitals in the UK. Adults, with SARS-COV-2 infection associated disease, hospitalised with an expected hospital discharge within 5 days will be eligible to participate in the study. Participants will be randomly assigned to one of the study treatments or standard of care and will be followed up for 12 months. Information will be collected from their routinely collected health records (mortality and subsequent hospitalisations) to minimise the burden on study participants, alongside collection of remotely entered patient reported data (online portal or smartphone app) and quality of life assessments.
The trial is funded by the National Institute of Health Research (NIHR).
REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0121
Date of REC Opinion
7 Apr 2021
REC opinion
Further Information Favourable Opinion