An open label, prospective, non-comparative, multicenter, phase IV study to evaluate efficacy and safety of Remdesivir intravenous injection in treatment of subjects hospitalized with moderate to severe coronavirus disease (COVID-19). - NI

CiplaLtd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1. A voluntarily given informed consent from subjects and/or legally acceptable representative (in case subject is not conscious and oriented).
•2. Subjects of either gender and age between 18 and 65 years.
•3. Subjects who are hospitalized with suspected or laboratory confirmed SARS-CoV-2 infection and moderate to severe disease.
•Moderate COVID-19: Pneumonia with no signs of severe disease, with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air, respiratory rate more or equal to 24 per minute.
•Severe COVID-19: Severe pneumonia with clinical signs of pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air.

•1. Subjects with known allergy or hypersensitivity to Remdesivir or any of its components.
•2. Subjects with Chronic liver disease (ALT/AST >5ULN) and chronic renal disease (GFR <30ml/min).
•3. Pregnant or breastfeeding subjects.
•4. Any serious medical condition or evidence of multiorgan failure or abnormality of clinical laboratory tests that, investigators judgment, precludes the subjects in the subject safe participation in and completion of the study.
•5. Subject already treated with another COVID 19 therapy but has relapsed with a positive diagnosis.
•6. Anticipated transfer to another hospital which is not a study site within 72 hours.
•7. Concurrent treatment with other agents with actual or possible direct-acting antiviral activity against SARS-CoV-2 < 24 hours prior to study drug dosing.
•8. Participated in any other clinical trial or taken investigational drug within 1 month.

发起方

CiplaLtd