Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult ( >18 years) COVID-19 positive patients of either gender 2. Patients hospitalized in COVID-19 wards 3. Patients having SpO2 saturation of �90% on room air at enrolment
Exclusion criteria
Exclusion criteria: 1. Patients on mechanical ventilation 2. Patients requiring nasal oxygen >6 litres/minutes 3. Patients with respiratory disorders, bronchial asthma, or COPD 4. Existing pulmonary tuberculosis 5. Patients admitted in ICU 6. Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to recovery (defined as the satisfaction of criteriaââ?¬â?¢s 1, 2 or 3 of the 8-category ordinal scale for clinical improvement)Timepoint: End of study (up to 28 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortalityTimepoint: End of therapy;Mean oxygen saturation (SpO2)Timepoint: Recorded on daily basis after start of study therapy till patient is hospitalized or 28 days;Patient satisfaction score on a 5-point Likert scale of 1: Dissatisfied; 2: Neither satisfied nor dissatisfied; 3: Satisfied; 4: Somewhat satisfied; 5: Extremely satisfiedTimepoint: End of therapy;Percentage of patients requiring admission in ICUTimepoint: End of therapy;Percentage of patients requiring mechanical ventilationTimepoint: End of therapy;Percentage of patients requiring remdesivirTimepoint: End of therapy;Percentage of patients requiring tocilizumab/ Itolizumab/ bevacizumabTimepoint: End of therapy;Proportion of participants experiencing Treatment-Emergent Adverse Events (TEAE)Timepoint: End of study;Total duration of hospital stays (days)Timepoint: End of therapy | — |
Countries
India
Contacts
D Y Patil University School of Medicine