A Study to Evaluate the Efficacy of KOVIR Capsule (TD0069) in the Combination Regimen With Background Treatment in COVID-19 Patients Without Symptoms of Acute Respiratory Distress
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Change in the severity of daily symptoms
研究概览
简要总结
The acute pneumonia pandemic caused by a new strain of corona virus 2019, namely as COVID-19 by the World Health Organization (WHO), is a pandemic caused by SARS-CoV-2 virus. The reported symptoms vary from fever or chills, cough, shortness of breath, to muscle aches, headaches, loss of taste or smell.
The capsule KOVIR is a product based on the traditional medicine named "Ren shen bai du san" which is used to treat the cold conditions, also known as the initial plague according to the theory of traditional medicine.
详细描述
The acute pneumonia pandemic caused by a new strain of corona virus 2019, namely as COVID-19 by the World Health Organization (WHO), is a pandemic caused by SARS-CoV-2 virus. The reported symptoms have included, but are not limited to fever or chills, cough, shortness of breath, muscle aches, headaches, loss of taste or smell, diarrhea, dizziness, sore throat, abdominal pain, anorexia, and vomiting.
The capsule KOVIR is a product based on the traditional prescription named "Ren shen bai du san" which is used to treat the cold conditions, also known as the initial plague according to the theory of traditional medicine.
The study compares between standard dose regimen of KOVIR combined with background treatment in COVID-19 patients and only background treatment in COVID-19 patients. The study will enroll 700 participants to KOVIR group and 300 participant to Non-KOVIR group.
All participants will be treated and followed up in 14-day period. In case the participant meets the discharge criteria before 14 days, discontinuing the study drug will be done at the discretion of the investigators.
Screening procedures occur at Day 1. Periodic assessments are conducted daily from Day 2-14. Finally, End of study visit is conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged from 18-65, Vietnamese nationality
- •Participants diagnosed with Positive result of SARS-CoV-2 using real time RT-PCR test, Ct value <30 (equivalent to viral load > 3log)
- •Voluntary participation in the study by signing an informed consent
- •Ability to adhere to treatment according to the investigator's assessment
排除标准
- •Symptoms of severe upper and lower respiratory tract infections such as dyspnea, SpO2<93%.
- •Acute reduction of ventilation function of respiratory apparatus and/or respiration function of the lung in any of the following three groups:
- •Respiratory distress due to hypoxemia with PaO2 less than 60mmHg when breathing room air.
- •Respiratory distress due to hypercapnia with PaCO2 above 50mmHg
- •Mixed respiratory distress accompanied by both a decrease in PaO2 and an increase in PaCO2
- •Allergy/intolerance to any component of the study drug.
- •Inability to administer medicine.
- •Severe pneumonia as assessed by the investigator.
- •Inability to comply with study procedures or to ensure compliance with study drug administration as assessed by investigators.
结局指标
主要结局
Change in the severity of daily symptoms
时间窗: up to 14 days
Scale: 0 = Asymptomatic, 1 = Mild, 2 = Moderate, 3 = Severe
Mean duration of clinical symptoms
时间窗: up to 14 days
Mean time from baseline to no clinical symptom of COVID-19
Number of participants with respiratory distress complications requiring treatment
时间窗: up to 14 days
Occurrence of symptoms of respiratory distress complications requiring treatment
Number of Participants with Adverse Events as Assessed by CTCAE v5.0
时间窗: up to 30 days after last dose
Frequency and severity of Study drug-related adverse events, adverse events leading to study termination, serious adverse events (SAE)
次要结局
未报告次要终点