Open Label, Randomized, Controlled Phase 2 Proof-of-Concept Study of the Use of Favipiravir Compared to Standard of Care in Hospitalized Subjects With COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Time to Viral Clearance
研究概览
简要总结
To determine the effect of favipiravir + SOC v. SOC on COVID-19 viral clearance.
详细描述
This is an open label, randomized, controlled, multicenter Phase 2 proof-of-concept study of favipiravir in hospitalized subjects with Corona Virus Disease (COVID) -19. Subjects will be randomized within their study site and stratified by the severity of their disease to receive either favipiravir + standard of care (SOC) or SOC alone.
The dose regimen will be 1800 mg favipiravir bis in die (BID) plus SOC or SOC alone on Day 1 followed by 1000 mg BID favipiravir (800 mg BID for subjects with Child-Pugh A liver impairment) plus SOC or SOC for the next 13 days.
The study will have 14 days of treatment and 46 days of follow-up.
Approximately 50 patients are planned to be enrolled in the trial at approximately 8 study sites in the US.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18 to 80 years old):
- •within 72 hours of their hospitalization for infection with Severe Acute Respiratory Syndrome - Corona Virus - 2 (SARS-CoV-2), AND,
- •within 72 hours of the latest Polymerase Chain Reaction (PCR) positive result and within 7 days of the 1st PCR positive result for SARS-CoV-
- •(The latest PCR could be the only PCR result.), AND,
- •within 10 days of onset of any COVID-19 symptoms.
排除标准
- •Subject has a concomitant bacterial respiratory infection unless cleared by the Sponsor
- •Subject has a history of abnormalities of uric acid metabolism unless cleared by the Sponsor.
- •Subject has a history of hypersensitivity to an anti-viral nucleoside analog drug targeting a viral RNA polymerase
- •Subject is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). Dexamethasone 6 mg daily (PO or IV) for 10 days is permitted.
- •Subject has a serious chronic disease (e.g., human immunodeficiency virus (HIV), cancer requiring chemotherapy within the preceding 6 months, moderate or severe hepatic insufficiency and/or unstable renal, cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days).
- •Has previously received favipiravir within the past 30 days
- •Has renal insufficiency requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) or glomerular filtration rate of less than 20 mL/min.
- •Has liver impairment greater than Child-Pugh A.
- •Has a history of alcohol or drug abuse in the previous 6 months.
- •Has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year.
- •Has taken another investigational drug within the past 30 days.
- •Is on another antiviral or is participating in another clinical trial for the treatment of COVID-19
- •Subject is on a ventilator at the time of study entry
- •Is deemed by the Investigator to be ineligible for any reason.
研究组 & 干预措施
Favipiravir Treatment Arm
Day 1: favipiravir 1800 mg BID plus Standard of Care (SOC) Days 2-14: 1000 mg BID plus SOC. For subjects with Child-Pugh A liver impairment: Days 2-14: 800 mg BID plus SOC
干预措施: Favipiravir (Drug)
Standard of Care Arm
Standard of Care for 14 days
干预措施: Standard of Care (Other)
结局指标
主要结局
Time to Viral Clearance
时间窗: Day 29
To determine the effect of favipiravir + SOC v. SOC on viral clearance of COVID-19 as measured by nasopharyngeal and oropharyngeal sampling
次要结局
- Status of Clinical Recovery as Measured by the Study-specific 6-point Ordinal Scale(on Day 15)
- Time to the National Early Warning Score 2 (NEWS2) of 2 or Less, or Hospital Discharge(through Day 29)
- Characterize the Pharmacokinetics (PK) of Favipiravir in Plasma: Cmax(through Day 14)
- Characterized the Pharmacokinetics (PK) of Favipiravir in Plasma: Cmin(through Day 14)
- Characterized the Pharmacokinetics (PK) of Favipiravir in Plasma: Area Under Curve (AUC 0-24)(through Day 14)