Efficacy of Favipiravir Against Severe Ebola Virus Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 主要终点
- Case fatality rate
研究概览
简要总结
The purpose of this study is to explore the therapeutic efficacy of Favipiravir, a broad-spectrum antiviral drug against severe cases of Ebola Virus Disease (EVD), which is the most difficult aspect for clinical management of EVD due to its high fatality rate.
详细描述
This is a prospective, open-label, controlled phase 2 trial of Favipiravir among severe cases (cases with hemorrhage, severe dehydration, consciousness disorders, shock, and high blood viral load with Ct value below 20) of confirmed EVD patients in the capital area of Sierra Leone. Patients with 13 years of age or older would be assigned in an 1:1 randomised manner to receive WHO-recommended therapy (mainly symptomatic and supportive therapies, control group. WHO, World Health Organization.) or oral Favipiravir (1600 mg twice on the first day, followed by a twice-daily dose of 600 mg until negative blood viral load detection or death) plus WHO-recommended therapy (treatment group). The primary efficacy end point was case fatality rate.The secondary efficacy endpoint is blood (plasma)viral load. Optimal inclusion number is 240 cases (120 for each group), but considering the actual situation of pandemic area, the front line doctors have the right to reset the inclusion number, and modify the study protocol according to the actual situation in the front.
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
- None
入排标准
- 年龄范围
- 13 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or famale，13 -75 years of age
- •Clinical diagnosis of EVD
- •Positive blood viral RNA detection
- •With any one of the symptoms below:
- •Hemorrhage (including hematemesis, hemoptysis, hematochezia, hematuria, mucocutaneous hemorrhage), severe dehydration (including oliguria, anuria, feebleness, hypotension, tachycardia), consciousness disorders (including coma, delirium, confusion, convulsion), shock, and high blood viral load (Ct value below 20)
- •Not received any therapies for EVD
- •Provided written informed consent, by guardian or the patient himself
- •Be able to administrate and tolerate oral administration of tablets
排除标准
- •Severe vomiting
- •Pregnancy and breast-feeding
- •Received antiviral treatment against EVD
研究组 & 干预措施
Control
WHO-recommended therapies, mainly symptomatic and supportive treatments. Briefly: body fluid management (intravenous or oral, depending on patient status), balanced nutrition (including glucose, electrolytes, vitamin, et al.), preventing intravascular volume depletion, correcting profound electrolyte abnormalities, avoiding the complications of shock, defervesce, anti-diarrheal, acesodyne, anti-anxiety. For patients with positive Plasmodium detection or bacterial infection, apply artemether-lumefantrine or antibiotics respectively. Details refer to 'Manual for the care and management of patients in Ebola Care Units/Community Care Centres, Interim emergency guidance' and 'Clinical Management of Patients with Viral Haemorrhagic Fever: A Pocket Guide for the Front-line Health Worker' by WHO.
干预措施: WHO-recommended therapies (Other)
Treatment
WHO-recommended therapies plus oral administration of Favipiravir
干预措施: WHO-recommended therapies (Other)
Treatment
WHO-recommended therapies plus oral administration of Favipiravir
干预措施: Favipiravir (Drug)
结局指标
主要结局
Case fatality rate
时间窗: 14 days
次要结局
- Blood viral load(1-3 days)