Researchers report that colchicine reduced complications among patients with COVID-19. But critics have questioned the validity of study results reported by press release rather than in a peer-reviewed journal.
Researchers report that colchicine reduced complications among patients with COVID-19. But critics have questioned the validity of study results reported by press release rather than in a peer-reviewed journal.
Findings of the COLCORONA clinical trial, conducted by the Montreal Heart Institute (MHI), show that colchicine reduced hospitalisations and deaths in patients recently diagnosed with COVID-19 by 21% compared to placebo.
The phase 3, randomised, double-blind, placebo-controlled multicentre study was designed to evaluate the efficacy and safety of short-term colchicine in adult patients diagnosed with COVID-19 infection who have at least one high-risk factor for complications.
The trial took place in Canada, Europe, South Africa, South America and the United States and included around 4,500 patients aged over 40 who weren’t hospitalised at the time of enrolment. Patients were randomised to receive either 0.5 mg colchicine twice daily for the first three days and then once daily for the last 27 days, or placebo for 30 days.
Not all patients had a COVID-19 diagnosis confirmed by a PCR test – some were provisionally diagnosed as COVID positive on the basis of symptoms and contact with known COVID cases. Once these patients were excluded from the analysis and only patients with confirmed COVID infections were included, hospitalisations were reduced by 25%, the need for mechanical ventilation by 50% and deaths by 44%. These results were reported to be statistically significant.
The study results were published by press release last week by the MHI.
The trial was originally planned to include 6,000 patients, and run until March, but was stopped early because of the positive findings. In an interview with Stat News, the trial’s principal investigator, Dr Jean-Claude Tardif, director of the MHI Research Centre, explained that continuing the trial would have meant “waiting months when the drug could be useful to patients now”.
The government in Greece, one of the participating countries, apparently agrees – within days of the press release it gave the green light for colchicine prescription to COVID-positive people aged over 60 or any other adult with risk factors for complications.
Critics have questioned the reporting of results by press release, rather than peer-reviewed medical journal, which is usually only done when drug companies are required to alert investors about events that may affect share prices.
A gout drug shows promise for Covid-19, but skeptics worry about trusting science by press release https://t.co/FJChzc3h7B via @statnews
— Gideon Gil (@GideonGil) January 24, 2021
The main concern was the lack of detail in data provided, in particular the numbers of people experiencing complications: hospitalisation, ventilation or death. It’s likely the numbers would be too small to draw firm conclusions.
Co-principal investigator Dr Michael Pillinger, a rheumatology professor at New York University Medical School, acknowledged the concerns and encouraged people wait for the published results before drawing conclusions.
Agree completely! I encourage everyone to wait for our paper (coming soon) before drawing conclusions. https://t.co/foxEFxZstj
— Michael Pillinger (@MHPillingerMD) January 24, 2021
Dr Tardif told Stat News the results would be published shortly.
