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). - NA
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- Cipla Ltd
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. A voluntarily given written signed dated informed consent from subjects and/or legally acceptable representative.
- •2. Subjects of either gender and age between 18 and 75 years.
- •3. Confirmed diagnosis of mild to moderate COVID-19. (positivity in RTPCR
- •2019-nCoV test on respiratory tract specimens).
- •4. In case of moderate COVID-19, subjects with CT or Chest X-ray
- •documented pneumonia.
- •5. Subjects with pyrexia (axillary >=37â?? or oral >=37.5â??, or rectal>=38â??)
- •or either respiratory rate >24/min and <30/min or cough.
- •6. Subjects within 7 days from symptom onset or within 48 hours of
- •laboratory diagnosis of SARS-CoV2.
排除标准
- •1. Subjects with known allergy or hypersensitivity to Favipiravir or any of its components or to supportive care.
- •2. Subjects with Chronic liver disease (Child Pugh class B or C) and chronic renal disease (GFR <30ml/min).
- •3. Subjects with oxygen saturation (SPO2) <=90% or arterial oxygen
- •partial pressure (PaO2)/ fraction of inspired O2 (FiO2) <=300 mmHg.
- •4. 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.
- •5. Subjects with gout or hyperuricemia.
- •6. Pregnant or breast-feeding subjects.
- •7. 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).
- •8. 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.
- •9. Subject has a history of alcohol or drug abuse in the previous 6 months.
- •10. Subject has a psychiatric disease that is not well controlled where
- •controlled is defined as: stable on a regimen for more than one year.
- •11. Subject already treated with another COVID 19 therapy but has
- •relapsed with a positive diagnosis.
- •12. Anticipated transfer to another hospital which is not a study site
- •within 72 hours.
- •13. Participated in any other clinical trial or taken investigational drug
- •within 1 month.
研究者
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