Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Hospitalized adult age 18 to 70 years 2.Laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay 3.Moderate Covid-19 patients not requiring organ support 4.Mild Covid requiring hospitalization 5 Duration of Hospital less than 48 hours.
Exclusion criteria
Exclusion criteria: 1. Unlikely to survive after 48 hours from screening or unlikely to remain at the investigational site beyond 48 hours 2. Requiring organ support at screening (Organ support defined as need for ICU care, mechanical ventilation, Non Invasive Ventilation (NIV), High flow Nasal Oxygen at screening 3. Participation in any other clinical trial of an experimental treatment for COVID-19 4. Known hypersensitivity to the trial drug or its components 5. Pregnant women or women who are breastfeeding 6. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment 7. Unable to provide consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Need for Organ Support 2.All-cause Mortality at 28 days Timepoint: 1.All-cause Mortality at 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in RNA Levels(CT Values) 2. Change in cytokines and biomarker levelsTimepoint: day 1, 3 and 5 | — |
Countries
India
Contacts
St Johnâ??s Medical College Hospital