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From today, colchicine – a commonly used anti-inflammatory treatment – will be investigated in the Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial. This is the world’s largest clinical trial of treatments for patients hospitalised with COVID-19, taking place in 176 hospital sites across the UK and with over 18,000 patients recruited so far.

Professor Peter Horby, from the Nuffield Department of Medicine at the University of Oxford, UK, co-Chief Investigator of the RECOVERY trial, said ‘Colchicine is an attractive drug to evaluate in the RECOVERY trial as it is very well understood, inexpensive and widely available. If it works it would be another COVID-19 treatment that could be used immediately worldwide, even in the poorest countries.’

Inflammation (caused by an over-active immune system) is a key component of severe COVID-19, and can lead to lung damage, the need for mechanical ventilation, and death. Colchicine has a wide range of anti-inflammatory effects and has been used for centuries to treat gout and, more recently, other inflammatory conditions.

Professor Martin Landray, from the Nuffield Department of Population Health at the University of Oxford, who co-leads the RECOVERY trial, explained ‘Inflammation plays a major role in COVID-19 and we’ve already shown that treatment with one anti-inflammatory drug, dexamethasone, can reduce deaths in the most severely ill COVID-19 patients. Colchicine is very widely used to treat gout and other inflammatory conditions such as pericarditis. By including colchicine in the RECOVERY trial, we will be able to establish whether it helps tackle the worst consequences of COVID-19.’

It is anticipated that at least 2500 patients recruited to the RECOVERY trial will be randomly allocated to receive colchicine plus usual standard-of-care, and results will be compared with at least 2500 patients who receive the usual standard-of-care on its own. The dosage used will be 1000 micrograms for the first treatment, then 500 micrograms every 12 hours for a total of 10 days (or until discharge if sooner). The main outcome the RECOVERY trial will assess is mortality after 28 days. Other outcomes include the impact on hospital stay and the need for ventilation. Depending on recruitment rates, it is likely to be several months before there is enough evidence to conclude whether colchicine has a significant benefit in COVID-19 patients.

The decision to add colchicine to the trial was made by the University of Oxford researchers and trial steering committee leading the trial in conjunction with the Chief Medical Officer, following a recommendation by the UK COVID-19 Therapeutics Advisory Panel.

The other treatments currently being investigated in the RECOVERY trial are:

  • Tocilizumab (an anti-inflammatory treatment given by injection)
  • Convalescent plasma (collected from donors who have recovered from COVID-19 and containing antibodies against the SARS-CoV-2 virus)
  • REGEN-COV2 (an investigational anti-viral antibody combination produced by Regeneron)
  • Aspirin (at a dose which may prevent the complications of blood clotting)

Enrolment of patients to azithromycin (an antibiotic being used for its anti-inflammatory properties) closed earlier today. Over 2500 COVID-19 patients were randomly allocated to receive azithromycin and will be compared with over 5000 patients randomly allocated to usual standard-of-care on its own. Collection of information on health outcomes in these patients is ongoing.

The RECOVERY Trial is conducted by the registered clinical trials units with the Nuffield Department of Population Health in partnership with the Nuffield Department of Medicine. The trial is supported by a grant to the University of Oxford from UK Research and Innovation/National Institute for Health Research (NIHR) and by core funding provided by NIHR Oxford Biomedical Research Centre, Wellcome, the Bill and Melinda Gates Foundation, the Department for International Development, Health Data Research UK, the Medical Research Council Population Health Research Unit, and NIHR Clinical Trials Unit Support Funding.

The RECOVERY trial involves many thousands of doctors, nurses, pharmacists, and research administrators at 176 hospitals across the whole of the UK, supported by staff at the NIHR Clinical Research Network, NHS DigiTrials, Public Health England, Department of Health & Social Care, the Intensive Care National Audit & Research Centre, Public Health Scotland, the Secure Anonymised Information Linkage at University of Swansea, and the NHS in England, Scotland, Wales and Northern Ireland.