Colchicine (Colcrys) didn’t benefit patients hospitalized with moderate to severe COVID-19-related pneumonia, researchers found in the COLCOVID randomized trial.
Among more than 1,200 COVID-19 hospitalized patients, 25% of patients who received colchicine required invasive mechanical ventilation or died within 28 days after hospitalization, compared with 29% of those who received usual care alone (HR 0.83, 95% CI 0.67-1.02), reported Deepak L. Bhatt, MD, MPH, of Harvard Medical School in Boston, and colleagues.
Nor were there significant differences in 28-day mortality rates between colchicine and usual care (21% vs 22%, HR 0.88, 95% CI 0.70-1.12), the authors wrote in JAMA Network Open.
“Colchicine is a relatively safe, and in most parts of the world, inexpensive anti-inflammatory drug with which doctors everywhere are familiar,” Bhatt told MedPage Today. “However, the data from this trial do not show any significant benefit of colchicine in COVID patients, and the drug should not be used for that purpose.”
A prior meta-analysis had also suggested no benefit but more adverse events with colchicine as an add-on treatment for COVID-19. Usually used to treat gout or rheumatic disease, colchicine had looked promising in the COLCORONA trial, which showed no overall benefit for high-risk patients with mild COVID but a significant reduction in death or hospitalization in a subset with PCR-confirmed COVID-19.
In COLCOVID, “There appeared to be a possible signal of a modest degree of benefit that would need to be confirmed in a larger, adequately powered trial of either colchicine or maybe other drugs that have anti-inflammatory effects but have been repurposed for potential use in COVID patients,” Bhatt said.
However, he pointed out that finding funding for large enough trials to prove it could prove challenging.
Bhatt and colleagues’ trial randomized 1,279 patients from the Estudios Clinicos Latino América Population Health Research Institute in Argentina who had COVID-19-related pneumonia to receive colchicine with usual care or only usual care from April 17, 2020 to March 28, 2021. In this open-label, multicenter study, follow-up ended after 28 days. Symptomatic adults hospitalized with suspected or confirmed COVID-19 who had oxygen desaturation or severe acute respiratory syndrome were included.
Colchicine patients received a 1.5 mg loading dose after enrollment, followed by a 0.5 mg oral dose within 2 hours of their first dose, then for 14 days (or until discharge) were given a 0.5 mg oral dose twice daily. Patients with liver or kidney dysfunction or on concomitant drugs received reduced colchicine doses.
Exclusion criteria included chronic kidney disease, pregnant or breastfeeding mothers, and those with negative PCR COVID-19 test results.
Almost two-thirds of trial participants were men (65%), and the mean age was 62. Most were on corticosteroids (91%-92%), and anticoagulant use was common (23%-25%). Many patients had hypertension (47%-49%), diabetes (22%-24%), or chronic lung disease (9%-10%).
Average hospital stay for colchicine patients was similar to usual care patients (6 vs 7 days, respectively). Mean oxygen saturation was also similar (87.9% vs 88.1%).
The most common adverse event linked to colchicine was diarrhea (11%).
The researchers acknowledged limitations of the trial, including its open-label design. “Although our trial was powered to detect a 27% risk reduction, based on the current findings, it has little statistical power (approximately 33%) to detect a more modest treatment effect,” they added.
Study funding was provided by the Population Health Research Institute and the Fundacion ECLA.
Bhatt reported industry ties to AstraZeneca, Amarin, Forest Laboratories, Eisai, Bristol Myers Squibb, Sanofi Aventis, Ethicon, Medtronic, Pfizer, The Medicines Company, Roche, Cardax, Ischemix, Ironwood, Lilly, Amgen, PhaseBio, Chiesi, Synaptic, Idorsia, Abbott, Afimmune, Novo Nordisk, Regeneron, PLxPharma, Garmin, 89Bio, HLS Therapeutics, MyoKardia, Cereno Scientific, Fractyl, Contego Medical, Owkin, Novartis, Lexicon, Janssen, Ferring Pharmaceuticals, CellProthera, TobeSoft, Boehringer Ingelheim, K2P, CSL Behring, Level Ex, Bayer, Biotronik, Boston Scientific, CSI, Svelte, Phillips, Takeda, Merck, FlowCo, and Regado Biosciences.
Coauthors disclosed affiliations with Boston Scientific Medtronic, Meril, Edwards, Contrafect, Angelini, MSD, Gilead Sciences, Pfizer, Merck, Novartis, ViiV Healthcare, Lysovant, Janssen, Bayer, AstraZeneca, Bristol Myers Squibb, Boehringer-Ingelheim, Sanofi-Aventis, GlaxoSmithKline, Eli Lilly, Daiichi-Sankyo, Servier, Seqirus, Medicago, and Fresenius.