Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Injection Edaravone 60mg: IV infusion over one hour
for seven days Along with Standard of care as per ICMR guidelines for COVID treatment
Control Intervention1: Standard of care Plus P
Sponsors
Sparsh Foundation
Eligibility
Inclusion criteria
Inclusion criteria: Male and female above 18 years till 65 years with moderate COVID Disease
Exclusion criteria
Exclusion criteria: Patients with pre-existing kidney and liver diseases. Pregnant and lactating women Patients with hyperreactive airway disease and obstructive airway disease. Patients with co-infections. Immunocompromised patients, either by disease condition(HIV-AIDS..etc) or by drugs( immunomodulators..etc) Patients who are declining to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Mortality 2) Change in clinical progression of the disease recorded using the WHO approved 8 point ordinal scale 3) Change in markers of inflammation.- IL-6,CRP,Ferritin, D-dimer AND LDHTimepoint: 1) Mortality at 28 days 2) Change in clinical progression of the disease recorded using the WHO approved 8 point ordinal scale 3) Change in markers of inflammation.- IL-6,CRP,Ferritin, D-dimer AND LDH on Day 4 Day 7 and Day 10. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in lesion area on chest CT done during active disease 2)Changes in resting finger pulse oximetry readings 3) Changes in Post 6 minute walk pulseoximetry readings at 4 weekly intervals 4)Changes in spirometry findings at 4 weekly intervals Timepoint: Changes in lesion area on chest CT done during active disease and at end of 14 weeks. 2)Changes in resting finger pulse oximetry readings at 4 weekly intervals upto 14 weeks. 3) Changes in Post 6 minute walk pulseoximetry readings at 4 weekly intervals upto 14 weeks. 4)Changes in spirometry findings at 4 weekly intervals upto 14 weeks. | — |
Countries
India
Contacts
Public ContactDr John Paul M
Sparsh Hospital
Outcome results
None listed