A Phase III Confirmatory Study of K-237

Phase 3 Completed 1030 enrolled Kowa Company, Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The efficacy and safety of K-237 0.3-0.4 mg/kg orally administered once daily for 3 days will be evaluated in patients with mild COVID-19 using a randomized, double-blind, parallel-group comparative method with placebo as a control. Efficacy will be assessed using a stratified log-rank test to determine the superiority of the drug over placebo in terms of time to improvement in clinical symptoms from the start of study drug administration to 168 hours.

Timeline

Start: 2021-10-22
Primary completion: 2022-08-26
Completion: 2022-08-26

Outcome

Missed primary endpoint

paper The primary efficacy endpoint was approximately 96 h (approximately four days) for both ivermectin and placebo groups, which did not show statistically significant difference (stratified log-rank test, p = 0.61). PMID 38154616 ↗

paper The results show that ivermectin (0.3-0.4 mg/kg), as a treatment for patients with mild COVID-19, is ineffective PMID 38154616 ↗

Publications

Results Mikamo H, Takahashi S, Yamagishi Y, Hirakawa A, Harada T, Nagashima H, Noguchi C, Masuko K, Maekawa H, Kashii T, Ohbayashi H, Hosokawa S, Maejima K, Yamato M, Manosuthi W, Paiboonpol S, Suganami H, Tanigawa R, Kawamura H; IVERMILCO Study Group. Efficacy and safety of ivermectin in patients with mild COVID-19 in Japan and Thailand. J Infect Chemother. 2024 Jun;30(6):536-543. doi: 10.1016/j.jiac.2023.12.012. Epub 2023 Dec 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ivermectin	Small molecule	0.3 mg/kg	Oral
Subject	Ivermectin	Small molecule	0.4 mg/kg	Oral