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All Studies   Meta Analysis       

The effects of colchicine on hospitalized COVID-19 patients: A randomized, double-blind, placebo-controlled clinical trial

Kasiri et al., Journal of Investigative Medicine, doi:10.1177/10815589221141815, IRCT20190804044429N5
Jan 2023  
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Mortality 7% Improvement Relative Risk Ventilation 7% ICU admission -24% Recovery, day 14 28% Recovery, day 7 12% Recovery time 14% Colchicine  Kasiri et al.  LATE TREATMENT  DB RCT Is late treatment with colchicine beneficial for COVID-19? Double-blind RCT 110 patients in Iran (February - May 2021) Improved recovery with colchicine (not stat. sig., p=0.59) c19early.org Kasiri et al., J. Investigative Medicine, Jan 2023 Favorscolchicine Favorscontrol 0 0.5 1 1.5 2+
Colchicine for COVID-19
5th treatment shown to reduce risk in September 2020, now with p = 0.00000031 from 56 studies.
Lower risk for mortality, ICU, hospitalization, and recovery.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 112 treatments. c19early.org
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.
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.
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%).
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.
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.
recovery time, 14.3% lower, relative time 0.86, p = 0.06, treatment 55, control 51.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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.
This PaperColchicineAll
The effects of colchicine on hospitalized COVID-19 patients: A randomized, double-blind, placebo-controlled clinical trial
Hossein Kasiri, Mobin Ghazaiean, Nima Rouhani, Fahimeh Naderi-Behdani, Monireh Ghazaeian, Robabeh Ghodssi-Ghassemabadi
Journal of Investigative Medicine, doi:10.1177/10815589221141815
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.
Authors' contributions Hossein Kasiri and Mobin Ghazaiean: Data Curation, Investigation. Nima Rouhani: Project Administration. Fahimeh Nader-behdani: Writing-original draft. Monireh Ghazaeian: Conceptualization, Methodology, Supervision, Writing-review & editing. Robabeh Ghodssi-Ghassemabadi: Formal analysis and Data Curation. Declaration of conflicting interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Ethics approval This study abides by the Declaration of Helsinki and was approved by the Ethics Committee of Mazandaran University of Medical Sciences (IR.MAZUMS.REC.1399.914). Supplemental material Supplemental material for this article is available online.
References
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Deftereos, Giannopoulos, Vrachatis, Effect of colchicine vs standard care on cardiac and inflammatory biomarkers and clinical outcomes in patients hospitalized with coronavirus disease 2019: the GRECCO-19 randomized clinical trial, JAMA Netw Open
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Manenti, Maggiore, Fiaccadori, Reduced mortality in COVID-19 patients treated with colchicine: results from a retrospective, observational study, PLoS One
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Late treatment
is less effective
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