A Multi-Center, Open label, Post approval for restricted use under emergency situation study to assess the Safety and Efficacy of Remdesivir in moderate to severe SARS CoV2 infection (COVID 19) in Indian patients.

Jubilant Generics Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年4月3日

试验速览

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•1.Age -18 years and above (no upper age limit)
•2.Patients admitted in hospital with a proven diagnosis of moderate to severe COVID 19 infection.
•3.Patients with moderate disease defined as patients with presence of clinical features pneumonia with dyspnea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air, respiratory rate more or equal to 24 per minute.
•4.Patients with severe disease defined as patients with clinical signs of pneumonia with respiratory rate >30 breaths/min or severe respiratory distress or SpO2 <90% on room air.

•Exclusion Criteria:
•1.Known hypersensitivity or idiosyncratic reaction to Remdesivir, its excipients or similar classes of drugs.
•2.Inability of subject or legally authorized representative to provide written informed consent.
•3.Patients with <40 kg body weight
•4.eGFR less than 30 mL per minute
•5.Pregnant or nursing women
•6.Patients with ALT/AST >= 5 times the upper limit of normal at baseline
•7.Evidence of multiorgan failure
•8.Mechanically ventilated (including Veno-Venous ECMO) >= 5 days, or any duration of Veno-Arterial ECMO
•9.Exposed to other investigational drugs within 30 day of first administration of Remdesivir.
•10.Unsuitable for the study in the opinion of the Investigator.

发起方