NCT05056883已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,030
- 试验地点
- 55
- 主要终点
- Time from the start of study drug administration to 168 hours until the clinical symptoms reach an improving trend
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons who meet all of the following criteria will be eligible for this clinical trial.
- •Males and females who are 12 years of age or older at the time of obtaining consent
- •Those who are confirmed positive for SARS-CoV-2 by antigen test or RT-PCR test using specimens (nasopharynx, nasal cavity, oropharynx, or saliva) collected within 120 hours prior to obtaining consent.
- •Patients who have fevers (37.5 degrees Celsius or higher) and/or at least one of the following symptoms of Score 2 or higher at a screening test: Myalgia, sore throat, diarrhea, nausea, vomiting, cough, and shortness of breath.
- •Patients with a room air oxygen saturation (SpO2) of 96% or higher at the time of the screening test.
排除标准
- •Subjects who meet any one of the following criteria will be excluded from this study.
- •Patients who have had symptoms caused by COVID-19 for more than 6 days on the day of initiation of study drug administration (Day 1) with the day of onset of symptoms as Day
- •Patients who need to receive concomitant therapy or administration of prohibited drugs during the study period
- •Patients who have taken or received drugs that have or may have antiviral activity against SARS-CoV-2 within 2 weeks prior to the start of study drug administration.
- •Patients currently using antiviral drugs
- •Patients with suspected complications of infectious diseases other than COVID-19
- •Subjects with a history of COVID-19 within 1 month prior to obtaining consent
- •Persons whose weight at the time of the screening test falls into the following categories (The first decimal place of the weight shall be rounded off.) 1) Those who are 18 years of age or older at the time of consent and weigh less than 25 kg or more than 127 kg 2) Those who are between 12 and 18 years of age and weigh less than 40 kg or 127 kg or more at the time of obtaining consent.
- •Patients undergoing dialysis treatment
- •Patients wno have severe liver dysfunction (hepatic dysfunction, hepatic fibrosis, etc.)
- •Patients with poorly controlled hypertension (systolic blood pressure (SBP) of 180 mmHg or higher or diastolic blood pressure (DBP) of 110 mmHg or higher)
- •Patients with complications of diabetic retinopathy, diabetic nephropathy, or diabetic neuropathy
- •Patients with heart failure of NYHA Class III or higher
- •Patients with malignant tumors or those judged to have a high possibility of recurrence
- •Patients requiring oxygen therapy
- •A person who has a complication of methemoglobinemia or any other disease that may cause measurement error of the pulse oximeter
- •Patients with a history of serious drug allergy (anaphylactic shock, etc.)
- •Pregnant women, lactating women, or women who plan to become pregnant or lactate during the study period
- •Subjects who have had more than 400 mL of whole blood drawn within 16 weeks or more than 200 mL within 4 weeks prior to obtaining consent, or component blood (plasma and platelet components) drawn within 2 weeks
- •Patients who have been administered IVM.
- •Those who have participated in other clinical trials and received medication at the time of obtaining consent, or those who have received an investigational drug other than placebo for less than 16 weeks
- •Others who are judged by the investigator or others to be inappropriate to participate in the study.
研究组 & 干预措施
Treatment A
Experimental
K-237 0.3-0.4mg/kg (once daily)
干预措施: K-237 0.3-0.4mg/kg (once daily) (Drug)
Control A
Placebo Comparator
Placebo (once daily)
干预措施: Placebo 0.3-0.4mg/kg (once daily) (Drug)
结局指标
主要结局
Time from the start of study drug administration to 168 hours until the clinical symptoms reach an improving trend
时间窗: Day1～11 after administration
次要结局
- In addition to the primary endpoint, time to trend toward improvement in clinical symptoms, including headache, abdominal pain, nasal(Day1～11 after administration)
- Time to reach a temperature of less than 37.5 ˚C without the use of antipyretics (acetaminophen)(Day1～11 after administration)
研究者
研究点 (55)
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