An open label, prospective comparative study to evaluate the proposed therapy in adults with mild symptomatic COVID-19 patients receiving the standard treatment of COVID infection.
Phase 3
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/09/027944
- Lead Sponsor
- Public Health Department
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Patients of both Gender aged more than 18 years old.
2.Willing and able to provide written informed consent.
3.Patients with Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV2 / COVID) infection confirmed by RT Polymerase chain reaction (RT-PCR) test
4.Currently hospitalized and requiring medical care for COVID-19
5.Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening
Exclusion Criteria
1.Subjects having less than 18 years of age
2.Drug atopy subjects
3.Private positive patients/ Truenaat positive/ Antigen positive
4.Critical comorbities
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compared to standard of treatment receiving in COVID -19 infection, proposed regimen if consumed as an add on therapy prescribed by physician as per the clinical conditions and disease outcome will be efficacious in reducing medically attended lung infection caused by RT-PCR-confirmed COVID-19 virus in COVID Positive adults more than age 18 yrs .Timepoint: 14 Days
- Secondary Outcome Measures
Name Time Method There will be a reduction in the incidence of hospitalizations attributable to COVID-19 in patients treated with proposed regimen <br/ ><br> <br/ ><br>There will be minimal chances of respiratory failure in patients due to COVID-19 in patients treated with proposed regimen <br/ ><br>Timepoint: 14 days