Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: J101- Influenza due to other identifiedinfluenza virus with other respiratory manifestations
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1 Age 18 to 60 years 2 COVID-19 positive as determined by PCR or other approved commercial or public health assay 3 Willing and able to provide written informed consent prior to performing study procedures
Exclusion criteria
Exclusion criteria: 1 Participation in any other clinical trial of an experimental treatment for COVID 19 2 Patients with severe COVID 19 disease defined as follows 3 Respiratory distress as determined by >=30 breaths per min oxygen saturation at rest Severe disease complications e g respiratory failure requirement of mechanical ventilation, septic shock or non-respiratory organ failure 4 Patients with deranged liver functions i.e Total bilirubin 5 Patients with unstable angina or history of Myocardial infarction or underwent CABG 6 Patients with known diagnosis of COPD 7 Pregnant women or women who are breastfeeding Immunocompromised patients or patients taking immunosuppressant medication or Patients with active malignancy Consideration by the investigator for any reason that the subject is an unsuitable candidate to receive study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of patients progressed to severe stage. Severe stage defined as â?¢ respiratory distress (â?¥30 breaths per min); â?¢ oxygen saturation at rest â?¤85%; â?¢ severe disease complications (eg, respiratory failure, requirement of mechanical ventilation, septic shock, or non-respiratory organ failure). Timepoint: Day 0 Till day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of Pro inflammatory cytokines. Disease severity on an ordinal scale. Length of time to clinical improvement and clinical progression Evaluation of D-dimer Length of time to normalization of fever, normalization of oxygen Duration of supplemental oxygen and /mechanical ventilation Number of participants that developed ARDS Duration required to get COVID-19 PCR test negative Duration of hospitalization /or ICU stay Percent mortality Timepoint: Till day 10 | — |
Countries
India
Contacts
Ayurved Rasayani