Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Documented COVID-19 infection as observed by positive RT-PCR for SARS-CoV-2 on the day of screening. Adult having moderate form of infection defined as presence of clinical features of dyspnea, and or hypoxia, fever, cough including spO2
Exclusion criteria
Exclusion criteria: Patients suffering from severe Covid-19 disease as per the physicianâ??s discretion. History of Chronic illness will be obtained and those with a history of active, ongoing disease will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time To Response TTR measured as the number of days since randomization in which there is reduction of at least one severity level of the disease measured using a World Health Organization 8 Point Ordinal Scale for Clinical Improvement WHO OSCI.Timepoint: Baseline and 3 weeks (21 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| A decrease in the swab viral load of SARSCOV2 Reduction in the need for intensive care in the treatment arm versus SOC A decrease in inflammatory markers will be measured at screening and End of TreatmentTimepoint: Baseline and 3 weeks (21 days) 8.5 weeks (60 days) if SAE occurs | — |
Countries
India
Contacts
ClinSync Clinical Research Pvt. Ltd.