Clinical trial of ShatPlus as an immunomodulator in adult Covid 19 positive patients
Phase 2
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/06/025999
- Lead Sponsor
- BVG Life Sciences Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients admitted with RT-PCR confirmed COVID-19 illness.
Mild to Moderately Covid 19 disease (NEWS score less than or equal to 8)
Signed informed consent must be obtained and documented according to AYUSH GCP, and national/local regulations.
Exclusion Criteria
Pregnant women
Breastfeeding women
Requiring ICU admission at screening
Patients above 65 years of age and below 18 Years
Past History of MI, Epileptic episodes
Any other co-morbidity (uncontrolled diabetes, severe hypertension from subject history) which is at critical stage at screening
Any other condition by which subject proves unfit from investigator perspective
Not giving consent.
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 COVID 19 <br/ ><br>Change in clinical symptom presentation in Cough, breathlessness, persistent pain and pressure in the chest, bluish discoloration of lips/ face on 5 point ordinal scale <br/ ><br>Serum levels of CD4, CD8, NK cell panel CD16/CD56, CRP, IgM, IgG <br/ ><br>Clinical status expressed in percentage of subjects reporting each severity rating on a 6-point ordinal scale <br/ ><br>Timepoint: Screening visit, Day 0, Day 4, Day 7 and Day 10 end of study
- Secondary Outcome Measures
Name Time Method Change in National Early Warning Score <br/ ><br>Hematological parameters like WBS, HB and platelet count etc. <br/ ><br>Requirement of admission to intensive care unit <br/ ><br>Reduced hospital duration <br/ ><br>Total days admitted to the hospital (difference between admission date and discharge date of index admission) <br/ ><br>Safety and tolerability of the intervention <br/ ><br>Changes in biochemical parameters such as Lipid function test, liver function test, renal function test, electrolyte etc.Timepoint: Screening visit, Day 0, Day 4, Day 7 and Day 10 end of study