Efficacy and Safety of Longan Extract Spray (P80 Spray) in Volunteers With Coronavirus Disease 2019 (COVID-19)
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Nasal swab test negative
研究概览
简要总结
The objectives of this study are to evaluate efficacy and safety of longan extract spray (P80 spray) in volunteers with coronavirus disease 2019 (COVID19).Patients who infected COVID 19 (positive COVID 19 RT-PCR from nasal swab) are enrolled in the study. They will be treated with standard treatment of COVID 19. In addition, the patients will received longan extract nasal spray (P80 spray) or placebo nasal spray for 3 days (6 times). After that, they will be nasal swabbed for detecting COVID 19 infection. Adverse event will also be evaluated by physician or nurse.
详细描述
Patients who infected COVID 19 (positive COVID 19 RT-PCR from nasal swab) and pass inclusion criteria are enrolled in the study. The patients will be checked the clinical symptoms and chest x-ray by physician. They will be treated with standard treatment of COVID 19. In addition, the patients will received longan extract nasal spray (P80 spray) or placebo nasal spray for 3 days (6 times). Physician or nurse will ask for adverse events every day. After 3 days, the patients will be nasal swabbed for detecting COVID 19 infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years
- •Positive nasal swab test of coronavirus disease 2019 (COVID-19) (reverse transcriptase-polymerase chain reaction (RT-PCR) เป็นบวก (cycle threshold <40))
- •Mild symptom with normal chest radiograph
- •No history of Chronic Obstructive Pulmonary Disease (COPD) and other chronic lung diseases, Chronic kidney disease (CKD), Cardiovascular diseases and congenital heart diseases, Cerebrovascular diseases, Poorly controlled diabetes,BMI > 35 kg/m2, Cirrhosis, Immunocompromised condition
- •Can read and write
- •Vulnerable to participate
排除标准
- •Allergic history to longan
- •Uncontrollable disease status
- •Pregnancy or lactation
- •Participated in other studies
研究组 & 干预措施
Longan nasal spray
The patients will be received 2 puff of Longan nasal spray 2 times/day for 3 days.
干预措施: Longan nasal spray (Other)
Placebo nasal spray
The patients will be received 2 puff of placebo nasal spray 2 times/day for 3 days.
干预措施: Placebo (Other)
结局指标
主要结局
Nasal swab test negative
时间窗: 3 days
There will be a negative reverse transcriptase-polymerase chain reaction (RT-PCR) test
次要结局
- Absent of respiratory symptoms(3 days)
- No adverse event(3 days)
研究者
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University