Clinical trial on COVID 19 patients to Improve Immunity
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/08/027041
- Lead Sponsor
- Venkat Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Subjects aged 18-65 years of age and of either sex
2.Subjects who are willing to give consent to the study
3.COVID-19 positive clinical symptoms and (subsequently) confirmedby the current recommended confirmatory test.
4.Mild to moderate clinical disease
5.Can take oral medicines
6.Subject willing to abide by and comply with the study protocol
1.Age less than 18 years and more than 65 years
2.Pregnancy and lactation
3.Severe or complicated course of COVID-19 disease
4.Presence of acute hypoxic respiratory failure/ need for Intensive care unit (ICU) stay/Patients who need mechanical ventilation.
5.Subjects taking steroid treatment and or any kind ofimmunosuppressive therapy
6.Any uncontrolled systemic disease, infection
7.Those with serious Cardiovascular, Cerebrovascular, Respiratory, Liver or Renal disease or any other disorder.
8.Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in LDH, TLC, CRP, D-DIMER and RT PCR from baseline to end of the studyTimepoint: Day 0 and End of the study (Day 7 to 14)
- Secondary Outcome Measures
Name Time Method 1.Adverse events (AEs), frequency and severity <br/ ><br>2.Number of subjects who discontinue study due to adverse events <br/ ><br>3.Changes in vital parameters and safety laboratory parameters <br/ ><br>Timepoint: Day 0 and Day 14