COVID-19 and Rheumatology

COVID-19 and Rheumatology

Disclosures: This study was funded by the Population Health Research Institute and Fundacion ECLA. Bhatt reports grants from Amarin, AstraZeneca, Forest Laboratories, Bristol Myers Squibb, Eisai, Ethicon, Medtronic, Sanofi Aventis, The Medicines Company, Roche, Pfizer, Ischemix, Cardax, Amgen, Eli Lilly & Co., Chiesi, Ironwood, PhaseBio, Idorsia, Synaptic, Abbott, Regeneron, Novo Nordisk, Fractyl, Cereno Scientific, Afimmune, Ferring Pharmaceuticals, Contego Medical, CellProthera, Lexicon, MyoKardia, Owkin, HLS Therapeutics, Janssen, 89Bio, Garmin, PLxPharma, and Novartis; personal fees from Duke Clinical Research Institute, the Mayo Clinic, the Population Health Research Institute, the American College of Cardiology, Belvoir Publications, Slack Publications, WebMD, Elsevier, the Society of Cardiovascular Patient Care, HMP Global, Harvard Clinical Research Institute, the Journal of the American College of Cardiology, the American Heart Association, the Cleveland Clinic, Mount Sinai School of Medicine, TobeSoft, Boehringer Ingelheim, Bayer, Medtelligence/ReachMD, CSL Behring, MJH Life Sciences, Level Ex, K2P, and the Canadian Medical and Surgical Knowledge Translation Research Group; serving as a site coinvestigator for Abbott, Biotronik, Boston Scientific, CSI, St. Jude Medical, Philips, and Svelte; performing unfunded research for FlowCo, Merck, and Takeda; serving on an advisory board for Medscape Cardiology and Regado Biosciences; serving as a deputy editor for Clinical Cardiology and on the publications committee for VA CART Research and Publications Committee; and serving on the board of directors for Boston VA Research Institute. Please see the study for all other authors’ relevant financial disclosures.
January 12, 2022
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Colchicine fails to reduce mechanical ventilation, 28-day mortality in COVID-19 pneumonia

Disclosures: This study was funded by the Population Health Research Institute and Fundacion ECLA. Bhatt reports grants from Amarin, AstraZeneca, Forest Laboratories, Bristol Myers Squibb, Eisai, Ethicon, Medtronic, Sanofi Aventis, The Medicines Company, Roche, Pfizer, Ischemix, Cardax, Amgen, Eli Lilly & Co., Chiesi, Ironwood, PhaseBio, Idorsia, Synaptic, Abbott, Regeneron, Novo Nordisk, Fractyl, Cereno Scientific, Afimmune, Ferring Pharmaceuticals, Contego Medical, CellProthera, Lexicon, MyoKardia, Owkin, HLS Therapeutics, Janssen, 89Bio, Garmin, PLxPharma, and Novartis; personal fees from Duke Clinical Research Institute, the Mayo Clinic, the Population Health Research Institute, the American College of Cardiology, Belvoir Publications, Slack Publications, WebMD, Elsevier, the Society of Cardiovascular Patient Care, HMP Global, Harvard Clinical Research Institute, the Journal of the American College of Cardiology, the American Heart Association, the Cleveland Clinic, Mount Sinai School of Medicine, TobeSoft, Boehringer Ingelheim, Bayer, Medtelligence/ReachMD, CSL Behring, MJH Life Sciences, Level Ex, K2P, and the Canadian Medical and Surgical Knowledge Translation Research Group; serving as a site coinvestigator for Abbott, Biotronik, Boston Scientific, CSI, St. Jude Medical, Philips, and Svelte; performing unfunded research for FlowCo, Merck, and Takeda; serving on an advisory board for Medscape Cardiology and Regado Biosciences; serving as a deputy editor for Clinical Cardiology and on the publications committee for VA CART Research and Publications Committee; and serving on the board of directors for Boston VA Research Institute. Please see the study for all other authors’ relevant financial disclosures.
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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.”

RH0122Diaz_Graphic_01
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 derived from Diaz R, et al. JAMA Netw Open. 2021;doi:10.1001/jamanetworkopen.2021.41328.

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.

Bhatt_Deepak_2022
Deepak L. Bhatt

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.”