Colchicine, a commonly used anti inflammatory drug, will be investigated as a possible treatment for coronavirus in the Randomised Evaluation of coronavirus Therapy (RECOVERY) trial, the study website posted on Friday.
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This is the world’s largest clinical trial of treatments for patients hospitalised with coronavirus, taking place in 176 hospital sites across the UK and with over 18,000 patients recruited so far.[break]
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 coronavirus treatment that could be used immediately worldwide, even in the poorest countries.’[break]
Inflammation (caused by an over active immune system) is a key component of severe coronavirus, 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.[break]
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 coronavirus and we’ve already shown that treatment with one anti inflammatory drug, dexamethasone, can reduce deaths in the most severely ill coronavirus 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 coronavirus.’[break]
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. [break]
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). [break]
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 coronavirus patients.
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 coronavirus 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) ■