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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,030
Ivermectin 3mg tablet
Placebo 3mg tablet
Time from the start of study drug administration to 168 hours until the clinical symptoms reach an improving trend
Time frame: Day1~11 after administration
In addition to the primary endpoint, time to trend toward improvement in clinical symptoms, including headache, abdominal pain, nasal
Time frame: Day1~11 after administration
Time to reach a temperature of less than 37.5 ˚C without the use of antipyretics (acetaminophen)
Time frame: Day1~11 after administration
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