Trials / Completed
CompletedNCT05056883
A Phase III Confirmatory Study of K-237
A Phase III Confirmatory Study of K-237-Multi-regional, Multi-center, Placebo Controlled, Randomized, Double Blind, Parallel Group Controlled Trial in Patients With Mild COVID-19
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,030 (actual)
- Sponsor
- Kowa Company, Ltd. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2021-10-22
- Primary completion
- 2022-08-26
- Completion
- 2022-08-26
- First posted
- 2021-09-27
- Last updated
- 2024-05-20
Locations
55 sites across 2 countries: Japan, Thailand
Source: ClinicalTrials.gov record NCT05056883. Inclusion in this directory is not an endorsement.