Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: COVID 19 positive patients 1 Mild category Group A Asymptomatic but positive for COVID 19. Group B Symptomatic URTI without comorbidity. Group C Symptomatic URTI with comorbidity. 2 Moderate category Pneumonia hypoxia , fever , cough including SpO2 less than 94 percent Range 90 to 94 percent on room air. Respiratory Rate more or equal to 24 per minute. 3. Male or non-pregnant female of Age >= 18 years at time of consent. 4. Women of child bearing potential agree to abstinence or one primary form of non-hormonal contraception during the study period. 5. Subject / LAR willing to give informed consent for the study and agrees not to participate in another clinical trial for COVID-19 during the course of this study and further agrees to be randomized to any treatment arm of the study.
Exclusion criteria
Exclusion criteria: COVID 19 positive patients 1 Stage II B Group E Pneumonia LRTI with respiratory failure. 2 Stage III Group F Pneumonia LRTI with respiratory failure multi organ dysfunction syndrome. 3 Physician makes the decision that trial is not in the best interest of the patient. 4 Anticipated discharge to another hospital within 72 hours. 5 Subject already on another trial for COVID-19
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to RecoveryTimepoint: Time to Recovery as defined on the Ordinal Scale censured at day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Change from baseline in monitored laboratory values 2 Change from baseline in Ordinal scale assessment 3 Mortality at day 7 4 Duration of hospitalization, use of NIV/HFNO 5 Incidence of new use of IMV/ECMOTimepoint: Day 3, Day 5 ,Day 7 | — |
Countries
India
Contacts
Sahyadri Hospitals Limited