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A Phase III Confirmatory Study of K-237

NCT05056883 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1030

Last updated 2024-05-20

No results posted yet for this study

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.

Conditions

  • Covid19

Interventions

DRUG

K-237 0.3-0.4mg/kg (once daily)

Ivermectin 3mg tablet

DRUG

Placebo 0.3-0.4mg/kg (once daily)

Placebo 3mg tablet

Sponsors & Collaborators

  • Kowa Company, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Japan
  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05056883 on ClinicalTrials.gov