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On the advice of its independent data monitoring committee (DMC), the RECOVERY trial has stopped recruitment to the colchicine arm for lack of efficacy in patients hospitalized with COVID-19.
“The DMC saw no convincing evidence that further recruitment would provide conclusive proof of worthwhile mortality benefit either overall or in any pre-specified subgroup,” the British investigators announced today.
“The RECOVERY trial has already identified two anti-inflammatory drugs — dexamethasone and tocilizumab — that improve the chances of survival for patients with severe COVID-19. So, it is disappointing that colchicine, which is widely used to treat gout and other inflammatory conditions, has no effect in these patients,” cochief investigator Martin Landray, MB ChB, PhD, said in a statement.
“We do large, randomized trials to establish whether a drug that seems promising in theory has real benefits for patients in practice. Unfortunately, colchicine is not one of those,” said Landry, University of Oxford, United Kingdom.
The RECOVERY trial is evaluating a range of potential treatments for COVID-19 at 180 hospitals in the United Kingdom, Indonesia, and Nepal, and was designed with the expectation that drugs would be added or dropped as the evidence changes. Since November 2020, the trial has included an arm comparing colchicine to usual care alone.
As part of a routine meeting March 4, the DMC reviewed data from a preliminary analysis based on 2178 deaths among 11,162 patients, 94% of whom were being treated with a corticosteroid such as dexamethasone.
The results showed no significant difference in the primary endpoint of 28-day mortality in patients randomized to colchicine vs usual care alone (20% vs 19%; risk ratio, 1.02; 95% CI, 0.94 – 1.11; P = .63).
Follow-up is ongoing and final results will be published as soon as possible, the investigators say. Thus far, they note, there has been no convincing evidence of an effect of colchicine on clinical outcomes in hospitalized COVID-19 patients.
Recruitment will continue to all other treatment arms — aspirin, baricitinib, Regeneron’s antibody cocktail, and, in select hospitals, dimethyl fumarate — the investigators say.
Cochief investigator Peter Hornby, MD, PhD, also from the University of Oxford, noted that this has been the largest trial ever of colchicine. “Whilst we are disappointed that the overall result is negative, it is still important information for the future care of patients in the UK and worldwide.”
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