Study of Favipiravir DPI in SARS-CoV-2 Infection.
Not Applicable
Completed
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/05/033750
- Lead Sponsor
- SAVA Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1.Age -18- 60 years (Both sex)
2.Confirmed COVID 19 patient with positive RT-PCR
3.Mild symptomatic or asymptomatic patients having no signs of severe disease (NEWS score <=6) and no comorbidity at screening
4.Subject willing to provide consent and follow up for study duration
Exclusion Criteria
1.Patients with compromised immunity, autoimmune disease or self-reports HIV or syphilis infection
2.Proves to be unfit for the study as per the investigatorâ??s discretion
3.Pregnant or lactating women
4.Requiring supplemental oxygen and ICU admission at screening
5.Comorbidity at screening and which in investigator discretion finds subject not suitable for the trial participation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method RT-PCR test for COVID 19- Day 5 and 10 <br/ ><br>Improvement of clinical symptoms including duration of respiratory distress, cough, sneezing and diarrhea <br/ ><br>Requirements of supplemental oxygen and SpO2 levels <br/ ><br>Reduction in elevated levels CRP, LDH, D-Dimer, Interleukin 6 and Ferritin <br/ ><br>Daily SpO2 levels from baseline to end of studyTimepoint: From baseline to day 10
- Secondary Outcome Measures
Name Time Method Changes in serum electrolyte levels- At screening and end of the study <br/ ><br>Changes in serum levels of liver enzymes such as SGPT and SGOT, creatinine- At screening and end of the study <br/ ><br>Requirement of admission to intensive care unit from baseline to end of study <br/ ><br>Duration of hospitalization from baseline to end of study <br/ ><br>Complete blood count, KFT, lipid profile at screening and end of the dayTimepoint: From baseline to day 10