A Multicenter, Double-blind, Double-dummy, Randomized, Parallel-controlled Clinical Study Evaluating Huashi Baidu Formula in the Treatment of Mild and Moderate Types of COVID-19 Disease.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Nucleic acid negative rate in 5 days;Virus CT value
研究概览
简要总结
Combined with the regional and population characteristics of Asia and Africa, Huashi Baidu Granule was used to intervene in mild and moderate patients with COVID-19, evaluate its efficacy and safety, and clarify its characteristics of action.
详细描述
In this study, a double-blind, double dummy, randomized control method was used to include 300 cases of mild and moderate COVID-19 patients in three centers at home and abroad. The clinical efficacy of Huashi Baidu Granule and Monapiravir in intervening COVID-19 patients was compared, It is proved that Huashi Baidu Granule has the same clinical efficacy and safety against COVID-19 as Monapiravir, and its characteristics of action are clarified to obtain high-level clinical evidence-based medical evidence of Huashi Baidu Granule in treating COVID-19 mild and moderate.
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
- Double (Participant, Investigator)
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
- •Conform to the diagnostic criteria for COVID-19 mild and moderate in the Guidelines for the Diagnosis and Treatment of Novel Coronavirus (COVID-19) Infection (Trial Version 10) ；
- •Age ≥ 18 years and ≤ 65 years;
- •The time from the first symptom (or confirmed onset) shall not exceed 5 days;
- •If the patient agrees to participate in the study, he/she will sign the informed consent form through paper signature, electronic signature of mobile software or voice authorization.
排除标准
- •Patients who cannot guarantee the compliance of taking medicine during the treatment period, and who are difficult to take medicine by oral or nasal feeding.
- •Patients with severe primary respiratory diseases or other pathogenic microorganism pneumonia that needs to be differentiated from COVID-
- •Pregnant women, with positive urine pregnancy test, or with pregnancy plan within 12 months.
- •Patients suffering from malignant tumors, mental diseases and other systematic malignant diseases that the researchers consider unsuitable for the study.
- •People who have ever been allergic to the test drug and who do not tolerate the drug.
- •Those who are participating in other clinical trials.
- •Non severe patients in the trial shall not enter the study again after changing the classification.
研究组 & 干预措施
Treatment group
Huashi Baidu Granule+Monapiravir simulant
干预措施: Huashi Baidu Granule (Drug)
Control group
Monapiravir+Huashi Baidu Granule Simulator
干预措施: Monapiravir (Drug)
结局指标
主要结局
Nucleic acid negative rate in 5 days;Virus CT value
时间窗: The treatment period，Receive the test by PCR once a daily ，for 5 consecutive days
Quantitative standard of viral CT value for nucleic acid detection： According to the Technical guidelines for laboratory testing of novel coronavirus, the Ct value of nucleic acid testing of novel coronavirus is less than 37, which can be reported is positive; No Ct value or Ct value greater than 40 was negative. If the Ct value was between 37 and 40, it is recommended to repeat the experiment. If Ct If the value is less than 40, the amplification curve has obvious peak, and the sample is judged as positive, otherwise it is negative.
次要结局
- Score of individual symptom(The treatment period, including 5 days after administration, and the follow-up period, which is day 11, day 21, and day 30 after administration, respectively)
- TCM symptom score(The treatment period, including 5 days after administration, and the follow-up period, which is day 11, day 21, and day 30 after administration, respectively)
- Hematological parameters(The treatment period, day one and day five after administration)
- Disease score(The treatment period, including 5 days after administration, and the follow-up period, which is day 11, day 21, and day 30 after administration, respectively)
- Symptom relief rate(30days)
- Rate of progression to severe COVID-19 cases(30days)