The effects of colchicine on hospitalized COVID-19 patients: A randomized, double-blind, placebo-controlled clinical trial
Very late treatment (10 days from onset) RCT 110 patients in Iran, showing no significant difference in outcomes with colchicine. Colchicine 2mg loading dose followed by 0.5mg bid for 7 days.
risk of death, 7.3% lower, RR 0.93, p = 1.00, treatment 6 of 55 (10.9%), control 6 of 51 (11.8%), NNT 117.
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risk of mechanical ventilation, 7.3% lower, RR 0.93, p = 1.00, treatment 6 of 55 (10.9%), control 6 of 51 (11.8%), NNT 117.
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risk of ICU admission, 23.6% higher, RR 1.24, p = 0.63, treatment 12 of 55 (21.8%), control 9 of 51 (17.6%).
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risk of no recovery, 27.9% lower, RR 0.72, p = 0.59, treatment 7 of 55 (12.7%), control 9 of 51 (17.6%), NNT 20, day 14.
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risk of no recovery, 11.7% lower, RR 0.88, p = 0.69, treatment 20 of 55 (36.4%), control 21 of 51 (41.2%), NNT 21, day 7.
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recovery time, 14.3% lower, relative time 0.86, p = 0.06, treatment 55, control 51.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Kasiri et al., 16 Jan 2023, Double Blind Randomized Controlled Trial, placebo-controlled, Iran, peer-reviewed, mean age 54.6, 6 authors, study period February 2021 - May 2021, average treatment delay 10.0 days, trial
IRCT20190804044429N5.
Contact:
ghazaeianm@gmail.com.
Abstract: Original Article
The effects of colchicine on hospitalized
COVID-19 patients: A randomized,
double-blind, placebo-controlled clinical
trial
Journal of Investigative Medicine
2023, Vol. 00(0) 1–8
Ó 2023 American Federation for
Medical Research
Article reuse guidelines:
sagepub.com/journals-permissions
DOI: 10.1177/10815589221141815
journals.sagepub.com/home/imj
Hossein Kasiri1, Mobin Ghazaiean2, Nima Rouhani3,
Fahimeh Naderi-behdani1, Monireh Ghazaeian4,
and Robabeh Ghodssi-Ghassemabadi5
Abstract
This study was designed to evaluate the effects of colchicine in the improvement of clinical outcomes of hospitalized
COVID-19 patients. This prospective, randomized, double-blind, placebo-controlled clinical trial was conducted on adult
patients (.18 years) with severe COVID-19. The included patients were randomly (1:1) assigned to the colchicine (2 mg
loading dose followed by 0.5 mg twice daily for 7 days) or placebo group. Both groups received remdesivir and interferon
beta-1b. The primary outcome of the study was to receive clinical response as ordinal scale of 1 or 2. Secondary outcomes
were hospital complications and 28-day mortality. Between February and May 2021, 110 patients were included and 106 of
them were analyzed. Baseline clinical characteristics and demographics were not significantly different. According to the ordinal scale, 30 patients in the control group (58.8%) responded to treatment within 7 days, while 35 patients (63.6%) in the colchicine group showed the same response (p = 0.61, odds ratio (OR) = 1.23, 95% CI [0.560–2.68]). On the 14th day, 87.3% of
the colchicine group (n = 48) and 82.4% of the control group (n = 42) responded (p = 0.48, OR = 1.47, 95% CI [0.50.3–4.29].
In addition, 28-day mortality, intensive care unit admission, and hospital duration were not different between the groups
(p = 0.99, 0.59, 0.06). Diarrhea and nausea were the major side effects dominant in the colchicine group. Colchicine showed
no beneficial effects on clinical improvement and hospital complications in patients with COVID-19. Moreover, in case of prescription, the safety concerns of colchicine, specially gastrointestinal side effects, should be taken into account.
Keywords
Colchicine, COVID-19, efficacy
Late treatment
is less effective
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