Colchicine fails to reduce mechanical ventilation, 28-day mortality in COVID-19 pneumonia
Colchicine fails to significantly reduce mechanical ventilation or 28-day mortality in hospitalized patients with COVID-19 pneumonia, compared with usual care, according to data published 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,” Deepak L. Bhatt, MD, MPH, FACC, FAHA, FSCAI, FESC, of Brigham and Women’s Hospital and Harvard Medical School, in Boston, told Healio. “Those attributes of colchicine led to this trial in patients hospitalized with COVID-19. If it had been positive, it would have been an easy to implement therapy for COVID.”
To analyze the efficacy of colchicine among hospitalized patients with COVID-19 pneumonia, Bhatt and colleagues conducted the COLOCOVID study, a multicenter, open-label, randomized clinical trial. A total of 1,279 adults hospitalized with confirmed or suspected COVID-19 — with severe acute respiratory syndrome characterized by shortness of breath or typical or atypical pneumonia on imaging, or oxygen desaturation — were randomized 1:1 to receive usual care or usual care plus colchicine.
Patients with clear indications or contraindications for colchicine, chronic kidney disease or a negative reverse transcription-polymerase chain reaction test for COVID-19 prior to randomization were excluded. In all, 639 patients were assigned to the usual care group, while 640 patients received colchicine. Corticosteroids were used in 1,171 participants, or 91.5% of the total study population.
Colchicine was administered orally in a loading dose of 1.5 mg immediately after randomization, followed by a 0.5 mg dose within 2 hours of the initial dose and additional 0.5 mg doses twice a day for 14 days or discharge. The trial was conducted from April 17, 2020, to March 28, 2021. Participants were followed for 28 days, with analysis conducted from June 20, 2021, to July 25, 2021. Main outcomes included new requirement for mechanical ventilation or death evaluated at 28 days, with death at 28 days serving as a second coprimary outcome.
According to the researchers, mechanical ventilation or 28-day death occurred in 25% of patients in the colchicine group, compared with 28.8% in the usual care group (HR = 0.83; 95% CI, 0.67-1.02). Meanwhile, the second coprimary outcome, 28-day death, occurred in 20.5% of those who received colchicine, compared with 22.2% in those who received usual care (HR = 0.88; 95% CI, 0.7-1.12). Diarrhea was the most frequent adverse effect of colchicine, reported in 11.3% of patients in the group.
“The data from this trial do not show any significant benefit of colchicine in COVID-19 patients, and the drug should not be used for that purpose at this time without further larger, definitive randomized trials that show clear benefit,” Bhatt said.
“There appeared to be a possible signal of a modest degree of benefit that would need to be confirmed in a larger, adequately sized trial of either colchicine or maybe other drugs that have anti-inflammatory effects but have been repurposed for potential use in COVID-19 patients,” he added. “Hopefully, such trials will occur, but it may be challenging to find funding to conduct trials that are large enough to be definitive.”