Clinical trial of ShatPlus in SARS-CoV-2 Infection.
Phase 1
Completed
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/05/025340
- Lead Sponsor
- BVG Life Sciences Ltd BVG Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
SARS-CoV-2 positive nasopharyngeal swab
Mild to Moderately severe disease (NEWS score <= 8)
Signed informed consent must be obtained and documented according to AYUSH GCP, and national/local regulations
Exclusion Criteria
Requiring ICU admission at screening
History of MI, Epileptic episodes
Any other comorbidity which is at critical stage at screening
Any other condition by which subject proves unfit from investigator perspective
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method o. of days for negative PCR confirmatory test from nasopharyngeal swab for SARS-Covid 2 <br/ ><br>Serum levels of CD4, CD8, NK cell panel CD16/CD56, CRP, IgM, IgGTimepoint: From baseline to end of study ie 10 days
- Secondary Outcome Measures
Name Time Method Clinical status of severity <br/ ><br>Change in National Early Warning Score <br/ ><br>Hematological parameters like WBS, RBC and platelet count etc. <br/ ><br>Change in clinical symptom presentation <br/ ><br>No. of days for negative PCR confirmatory test for SARS-Covid 2 <br/ ><br>Requirement of admission to intensive care unit <br/ ><br>Duration of hospital admission <br/ ><br>Total days admitted to the hospitalTimepoint: From baseline to end of study ie 10 days