Evaluating the Efficacy of Artesunate in Adults With Mild Symptoms of COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- length of stay in hospital
研究概览
简要总结
Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus.
At this time, there are no specific vaccines or treatments for COVID-19. However, there are many ongoing clinical trials evaluating potential treatments Drugs used to treat malaria infection has shown to be beneficial for many other diseases, including viral infections.
In this Clinical trial, Investigators will evaluate the effect of Artemisinin / Artesunate on morbidity of COVID-19 patients in decreasing the course of the disease and viral load in symptomatic stable positive swab COVID-19 patients. Investigators are hypothesizing that due to the antiviral properties of this drug it will help as a treatment for the COVID -19 patients. In improving their condition and clearing the virus load,
详细描述
In this Clinical trial, Investigators will evaluate the effect of Artemisinin / Artesunate on morbidity of COVID-19 patients in decreasing the course of the disease and viral load in symptomatic stable positive swab COVID-19 patients. investigators are hypothesizing that due to the antiviral properties of this drug it will help as a treatment for the COVID -19 patients. In improving their condition and clearing the virus load, investigators are testing two groups the one that will take the drug and then compare them to a placebo group that will not take any drug for the treatment in a blinded fashion made by randomization done by our pharmacy team so investigators eliminate risk of bias. Our expectation is to find a total reduction of the hospital stay to 7 days instead of 14 days currently indicating the effectiveness of the medication in eradicating the virus.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
the pharmacy will do the randomization of the labeled drug and placebo
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
- •Adult patient age more than 18 and less than 60 years
- •Symptomatic , positive swab covid-19 patients
- •Patients who have mild to moderate symptoms
- •Patients who have no risk factors like
- •Patients who is not on other medications rather those on supportive care
排除标准
- •· Patients who have sever disease- shortness of breath, sick patients or admitted in ICU
- •Patients who are receiving ventilation supports
- •High risk group like :- age more than 60 years, chronic heart diseases, chronic lungs diseases, diabetes, immunocompromised diseases or on immune suppression medications or pregnant women
- •Patients who are on other medications which used as treatment for covid 19
研究组 & 干预措施
placibo
this group will receive a placebo of the same shape and picture of the study drug
干预措施: placebo (Other)
intervention group
this group will receive the Artemisinin / Artesunate 100mg once daily for 5 days
干预措施: Artemisinin / Artesunate (Drug)
结局指标
主要结局
length of stay in hospital
时间窗: within the first 6 days intervention
absence of the virus shedding evidenced by negative swabs
次要结局
- number of ICU admission(14 days)
- resolution of symptoms(6 days - 10 day)
研究者
osama y kentab
Clinical Associate Professor of Emergency Medicine
Princess Nourah Bint Abdulrahman University