se of Clevira in COVID19 patients
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/05/025483
- Lead Sponsor
- Apex Laboratories Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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 °C armpit, >= 37.2 °C oral, or >= 37.8 °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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method