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Oral Colchicine and Low-Dose Aspirin Combination Therapy for Non-elderly, Non-severe, Early Time From Onset, Adult Outpatients with Coronavirus Disease 2019 (COVID-19) during “The Fifth Pandemic Wave” in Japan

Inokuchi et al., The Kurume Medical Journal, doi:10.2739/kurumemedj.MS7012003
Mar 2024  
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Hospitalization 67% Improvement Relative Risk Prolonged symptoms 24% Days until ≤37°C -17% Colchicine  Inokuchi et al.  EARLY TREATMENT  RCT Is early treatment with colchicine + aspirin beneficial for COVID-19? RCT 38 patients in Japan (July - September 2021) Trial compares with loxoprofen, results vs. placebo may differ Lower hospitalization with colchicine + aspirin (not stat. sig., p=0.55) c19early.org Inokuchi et al., The Kurume Medical J., Mar 2024 Favorscolchicine Favorsloxoprofen 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
RCT 38 low risk outpatients in Japan, showing no significant differences for colchicine and low-dose aspirin compared to loxoprofen. Hospitalization was lower, without statistical significance (4.3% vs. 13.3%, p=0.34). There were no critical cases, deaths, or severe adverse events in either group.
Colchicine: 1.0mg loading dose, followed approximately half a day later by 0.5mg twice daily for 10 doses, and then 0.5 mg once daily for four doses. Aspirin: 100mg daily for 10 days. Both groups received probiotics and acetaminophen.
Study covers aspirin and colchicine.
risk of hospitalization, 67.4% lower, RR 0.33, p = 0.55, treatment 1 of 23 (4.3%), control 2 of 15 (13.3%), NNT 11, day 28.
prolonged symptoms, 23.8% lower, RR 0.76, p = 0.72, treatment 8 of 21 (38.1%), control 6 of 12 (50.0%), NNT 8.4.
days until ≤37°C, 17.0% higher, relative time 1.17, p = 0.60, treatment 21, control 12.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Inokuchi et al., 19 Mar 2024, Randomized Controlled Trial, Japan, peer-reviewed, 16 authors, study period 27 July, 2021 - 6 September, 2021, average treatment delay 1.8 days, this trial compares with another treatment - results may be better when compared to placebo, this trial uses multiple treatments in the treatment arm (combined with aspirin) - results of individual treatments may vary. Contact: kita-sir1028@jcom.home.ne.jp.
This PaperColchicineAll
Oral Colchicine and Low-Dose Aspirin Combination Therapy for Nonelderly, Non-severe, Early Time From Onset, Adult Outpatients with Coronavirus Disease 2019 (COVID-19) during "The Fifth Pandemic Wave" in Japan
Tetsuaki Inokuchi, Tomoki Homma, Yasuhiko Kitasato, Mayu Akiyama, Ayako Chikasue, YUUYA NISHII ‡, § , SHIGEKI BAN* , § § , TAKEKI ADACHI* ,# , AYA SONEZAKI ‡ , HIROSHI MASUDA ‡ Hideki Kamei, Miki Takenaka, Maki Tanaka, Masaki Okamoto ##, Tomoaki Hoshino
Background: Treatment with antiviral drugs for non-severe, early time from onset, adult outpatients with Coronavirus Disease 2019 (COVID-19) had not been established in 2021. However, some new variants of SARS-CoV-2 had caused rapid exacerbation and hospitalization among non-elderly outpatients with COVID-19, contributing to widespread crises within healthcare systems. Methods: From July to October 2021, we urgently assessed a therapeutic program using oral colchicine (1.0 mg loading dose, followed approximately half a day later by 0.5 mg twice daily for 5 days, and then 0.5 mg once daily for 4 days) and low-dose aspirin (100 mg once daily for 10 days), for non-elderly, non-severe, early time from onset, adult outpatients with COVID-19. To verify its effectiveness, we set loxoprofen as a control arm, and comparison of these two arms was performed. The primary outcomes were hospitalization, criticality, and death rates. Results: Thirty-eight patients (23 receiving colchicine and low-dose aspirin [CA]; 15 receiving loxoprofen [LO]) were evaluated. Hospitalization rate was lower in the CA group (1/23; 4.3%) than in the LO group (2/15; 13.3%); however, no significant difference was found between the two groups (p=0.34). No critical cases, deaths, or severe adverse events were found in either group. Conclusions: Our CA regimen did not show superiority over LO treatment. However, our clinical experience should be recorded as part of community health care activities carried out in Kurume City against the unprecedented COVID-19 pandemic.
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