Overview

A Phase III Confirmatory Study of K-237

Status:
Not yet recruiting
Trial end date:
2022-03-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Kowa Company, Ltd.
Treatments:
Ivermectin