An Adaptive Randomised Placebo Controlled Phase II Trial of Antivirals for COVID-19 Infection
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Time to virological cure
研究概览
简要总结
This is a randomised placebo controlled phase II trial to examine the efficacy of antivirals to treat COVID-19 infection compared to placebo for virological cure and improved clinical outcomes. Individuals will be randomised to the candidate antiviral which in the first instance is Favipiravir or matched placebo and randomisation will be stratified according to whether the participant requires hospitalisation or not. This treatment will be given in addition to the usual standard of care in the participating hospital.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent by the participant or authorized representative
- •Age ≥18 years
- •Confirmed SARS-CoV-2 by nucleic acid testing in the past 5 days
- •COVID-19 related symptom initiation within 5 days
- •Female patients of childbearing potential must have a negative pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 1 week following the last dose of study treatment.
排除标准
- •Known allergy to the study medication
- •Is on another antiviral for the treatment of COVID-19
- •Pregnancy
- •Patients with severe hepatic dysfunction equivalent to Grade C in the Child-Pugh classification
- •Patients with renal impairment requiring dialysis
- •Is deemed by the Investigator to be ineligible for any reason
研究组 & 干预措施
Favipiravir
1800 mg Favipiravir twice daily on Day 1 followed by 800 mg Favipiravir twice daily for the next 13 days.
干预措施: Favipiravir (Drug)
Placebo
Matched Placebo
干预措施: Favipiravir (Drug)
结局指标
主要结局
Time to virological cure
时间窗: 14 days
Time to 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing
次要结局
- Safety(28 days)
- Clinical improvement(28 days)
- Clinical symptoms(28 days)
- Biomarkers(28 days)