Application of Colchicine Plus Herbal Phenolic Monoterpene Fractions to Treat COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mortality Rate
研究概览
简要总结
In this randomized controlled clinical trial, defined cases of COVID-19 with mild, moderate, or severe pneumonia (according to the NIH guideline) were treated with conventional treatment regimens (controls) as well as in combination with oral administration of colchicine plus herbal phenolic monoterpene fractions (intervention arm). After randomization, each group received the mentioned treatments and were evaluated for different variables including mortality, hospitalization duration, intensive care unit (ICU) administration ratios as well as laboratory variables such as leukocytes and lymphocytes count. The follow-up period considered as 2 weeks after discharge. The mentioned variables were assessed as before and after receiving the treatment in each group as well as intergroup analysis for comparing both baseline and final values.
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Defined cases of COVID-19 based on laboratory and/or radiological and clinical manifestation
排除标准
- •Age <10, Pregnancy, Sever kidney dysfunction, Previous history of allergy to Colchicine, not willing to sign informed consent form
研究组 & 干预措施
Standard Treatment
Patients diagnosed with COVID-19 which receive the standard treatment national guideline
干预措施: Standard Treatment (Drug)
Colchicine and Herbal Phenolic Monoterpene Fractions
Patients diagnosed with COVID-19 which receive the standard treatment national guideline plus Colchicine and Herbal Phenolic Monoterpene Fractions
干预措施: Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions (Drug)
结局指标
主要结局
Mortality Rate
时间窗: From admission to 14 days after being discharge.
All cause of death in duration hospitalization
次要结局
- SpO2(Admission to discharge dates (approximately 4-14 days after admission). Discharge variables considered as the last available data before their death for the expired patients.)
- Length of Hospitalization(The duration of hospitalization for the patients (admission to discharge dates, approximately 4-14 days after admission). The patients who died were excluded.)
- Lymphocyte Count(Admission to discharge dates (approximately 4-14 days after admission). Discharge variables considered as the last available data before their death for the expired patients.)
- Serum Lactate Dehydrogenase(Admission to discharge dates (approximately 4-14 days after admission). Discharge variables considered as the last available data before their death for the expired patients.)
研究者
Dr. Ali Mostafaie, PhD
Professor of Immunology
Kermanshah University of Medical Sciences