A Randomized, Multicentric, Open label, Parallel group Clinical study to Evaluate the EFFICACY and SAFETY of CLEVIRA in mild to moderate COVID19 POSITIVE Patients

Apex Laboratories Pvt Ltd0 个研究点目标入组 100 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Willing and able to provide written informed consent prior to performing study procedures.
•2. Males and females between the age of 18-50 years.
•3. Mild to moderate COVID-19 associated disease as defined by the WHO.
•4. Hospitalized patient.
•5. Has laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR.
•6.Illness of any duration and febrile/afebrile. Febrile-defined as temperature >= 36.6 Â°C armpit, >= 37.2 Â°C oral, or >= 37.8 Â°C rectal documented within 48 hours of consent.

•1. Participation in any other clinical trial of an experimental treatment for COVID-19
•2.Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study medication initiation
•3.Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
•4.Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30)
•5.Pregnant women or women who are breastfeeding
•6.Immunocompromised patients taking medication upon screening
•7.Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment

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