Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Laboratory confirmed diagnosis of Mild to Moderate COVID-19 patients 2. Agree to consent for the study. 3. All Age groups above 18 Years 4. All genders.
Exclusion criteria
Exclusion criteria: 1. Patients on ventilator 2. Critically ill patient 3. Dyspnea, respiratory frequency >= 30/min, 4. Blood oxygen saturation (SpO2) 5. PaO2/FiO2 ratio 50% within 24 to 48 hours 6. Patients with altered mental state 7. Patients with multiple organ failure requiring ICU monitoring and treatment. 8. Patients with respiratory failure and requiring mechanical ventilation/ 9. Patient who have participated in another investigational study within 3 months prior to enrollment in this study 10. Investigators, study personnel and their first-degree relatives. 11. Pregnant Patients 12. Current or future involvement in the active treatment phase of other interventional research studies (excluding observational/non-interventional studies). 13. Any other clinical reason which may preclude entry in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time (Days) to clinical improvement from study enrolmentTimepoint: At Baseline, Day three , Day five and Day seven | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical status as assessed by the 9-point ordinal scale 2. Duration of hospitalization 3. Proportion of participants in each group with need for mechanical ventilation 4. Rate of patients showing improvement of 2 points in 7 category ordinal scale 5. Functional status scale -post covid-19 at 1 week post discharge Follow up visit Timepoint: At Baseline, Day three , Day five and Day seven and at Discharge | — |
Countries
India
Contacts
Bhaktivedanta Hospital and Research Institute