medwireNews: Preliminary findings from the GRECCO-19 trial suggest that colchicine, an anti-inflammatory drug used in the treatment of gout and familial Mediterranean fever, may have potential as a therapeutic agent for COVID-19.
As reported in JAMA Network Open, the 55 hospitalized patients with confirmed SARS-CoV-2 infection who were randomly assigned to receive open-label colchicine were significantly less likely to experience the primary clinical endpoint of clinical deterioration – defined as a 2-grade increase on an ordinal clinical scale within 3 weeks after randomization or until discharge – than the 50 participants who were not given colchicine, with rates of 1.8% and 14.0%, respectively.
Colchicine was given as a loading dose (1.5 mg initially and 0.5 mg after 1 hour if no gastrointestinal adverse events occurred, or a single 1.0 mg dose if co-administered with azithromycin) followed by a maintenance dose of 0.5 mg once or twice daily, dependent on bodyweight, for a maximum of 21 days. The majority of participants also received chloroquine or hydroxychloroquine (98.1%) and azithromycin (92.4%) treatment.
Despite the clinical benefit, colchicine treatment did not significantly impact the main biochemical endpoints in the GRECCO-19 trial. Specifically, peak high-sensitivity cardiac troponin (hs cTn) levels – the first co-primary biochemical endpoint and a marker of myocardial injury – were comparable in the colchicine and control groups (median 0.0080 vs 0.0112 ng/mL).
“This probably indicates that although hs cTn may be considered a marker of adverse outcomes, myocardial injury itself may not be a major determinant of the clinical course in most patients with COVID-19,” write Spyridon Deftereos (National and Kapodistrian University of Athens, Greece) and co-authors.
They were unable to evaluate the second co-primary biochemical endpoint of the time taken for C-reactive protein (CRP) levels to reach more than three times the upper reference limit of normal, because the majority (68.6%) of participants already had CRP levels above the threshold at baseline, “which does not allow for any meaningful comparison between the 2 groups in terms of this variable.”
However, the investigators note that peak median dimerized plasma fragment D levels were significantly lower in the colchicine compared with the control arm (0.76 vs 0.92 μg/mL), “which suggests an anti-inflammatory and antithrombogenic effect.”
Taken together, the GRECCO-19 results “suggest a role for colchicine in the treatment of patients with coronavirus disease 2019,” say Deftereos and team. However, they caution that their study was limited by small patient numbers and therefore the findings “should be considered hypothesis generating.”
Writing in an accompanying commentary, Amir Rabbani and colleagues from the University of California, Los Angeles in the USA, say that colchicine is “an attractive potential therapeutic option for patients with COVID-19” given that it is well-established and cost-effective with a favorable safety profile.
“Indeed, colchicine would be an important addition to the frontline therapeutic COVID-19 resources accessible to patients even in resource-poor regions where costly and/or experimental treatments may not be available,” they add.
medwireNews is an independent medical news service provided by Springer Healthcare. © 2020 Springer Healthcare part of the Springer Nature Group
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JAMA Netw Open 2020; 3: e2013136
JAMA Netw Open 2020; 3: e2013556