CTRI/2020/06/025799暂停3 期
A Randomized, Open Label, Prospective, Comparative, Parallel Group,Multicentre Study To Evaluate Efficacy And Safety Of Favipiravir WithSupportive Care Versus Supportive Care Alone In Subjects With Mild ToModerate Coronavirus Disease (COVID-19).
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- Cipla Ltd
- 入组人数
- 156
- 试验地点
- 8
- 主要终点
- Time from randomization to negativity in RT-PCR nucleic acid test. [defined as the presence of two consecutive negative results with RT-PCR detection over an interval of 24 hour]
研究概览
简要总结
The studyis a randomized, open label,prospective, comparative, parallel group, multicentre study to evaluateefficacy and safety of Favipiravir with
supportivecare versus supportive care alone in subjects with mild to moderatecoronavirus disease (COVID-19)
The objectiveof study is to evaluate efficacy andsafety of Favipiravir with supportive care versus supportive care alone insubjects with mild to moderate coronavirus disease (COVID-19).
CRO for this trial will be CBCC Global Research
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •A voluntarily given written signed dated informed consent from subjects and/or legally acceptable representative.
- •Subjects of either gender and age between 18 and 75 years.
- •Confirmed diagnosis of mild to moderate COVID-
- •(positivity in RTPCR 2019-nCoV test on respiratory tract specimens).
- •In case of moderate COVID-19, subjects with CT or Chest X-ray documented pneumonia.
- •Subjects with pyrexia (axillary ≥37℃ or oral ≥37.5℃, or rectal≥38℃) or either respiratory rate >24/min and <30/min or cough.
- •Subjects within 7 days from symptom onset or within 48 hours of laboratory diagnosis of SARS-CoV2.
排除标准
- •Subjects with known allergy or hypersensitivity to Favipiravir or any of its components or to supportive care.
- •Subjects with Chronic liver disease (Child Pugh class B or C) and chronic renal disease (GFR<30ml/min).
- •Subjects with oxygen saturation (SPO2) ≤90% or arterial oxygen partial pressure (PaO2)/ fraction of inspired O2 (FiO2) ≤300 mmHg.
- •Refractory nausea, vomiting, or chronic gastrointestinal disorders, inability to swallow the study drug or having undergone extensive bowel resection which may affect adequate absorption of Favipiravir.
- •Subjects with gout or hyperuricemia.
- •Pregnant or breast-feeding subjects.
- •Subject is using adrenocorticosteroids (except topical or inhaled preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers).
- •Subject has a serious chronic disease (e.g., human immunodeficiency virus (HIV), cancer requiring chemotherapy within the preceding 6 months, unstable cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days.
- •Subject has a history of alcohol or drug abuse in the previous 6 months.
- •Subject has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year.
- •Anticipated transfer to another hospital which is not a study site within 72 hours.
- •Participated in any other clinical trial or taken investigational drug within 1 month.
结局指标
主要结局
Time from randomization to negativity in RT-PCR nucleic acid test. [defined as the presence of two consecutive negative results with RT-PCR detection over an interval of 24 hour]
时间窗: Up to 28 days
次要结局
- Time from randomization to clinical recovery(clinical recovery:normalization of pyrexia,respiratory rate and SPO2 and relief of cough that is maintained for at least 72 hours).Incidence of deterioration/aggravation of pneumonia.Time from randomization to resolution of pyrexia.Time from randomization to relief of cough.Time from randomization to relief of dyspnoea.Time to discharge from hospital.ICU admission rate. Adverse events(Serious/Non-serious,Expected/Unexpected,Related/Not Related)(Up to 28 days. Till discharge/death whichever is earlier (up to Day 28))
研究者
研究点 (8)
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