HElping Alleviate the Longer-term consequences of COVID-19(HEAL-COVID): a national platform trial
Funder: National Institute for Health Research (NIHR)
Sponsor: CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST
CI: Dr Charlotte Summers
Approval Date: 17 March 2021
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).
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