Study of Edaravone as adjunctive treatment in COVID
Not Applicable
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/10/028472
- Lead Sponsor
- Sparsh Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Male and female above 18 years till 65 years with moderate COVID Disease
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Mortality <br/ ><br>2)Change in clinical progression of the disease recorded using the WHO approved 8 point ordinal scale <br/ ><br>3) Change in markers of inflammation.- IL-6,CRP,Ferritin, D-dimer AND LDHTimepoint: 1)Mortality at 28 days <br/ ><br>2)Change in clinical progression of the disease recorded using the WHO approved 8 point ordinal scale <br/ ><br>3) Change in markers of inflammation.- IL-6,CRP,Ferritin, D-dimer AND LDH on Day 4 Day 7 and Day 10.
- Secondary Outcome Measures
Name Time Method Changes in lesion area on chest CT done during active disease <br/ ><br>2)Changes in resting finger pulse oximetry readings <br/ ><br>3) Changes in Post 6 minute walk pulseoximetry readings at 4 weekly intervals <br/ ><br>4)Changes in spirometry findings at 4 weekly intervals <br/ ><br> <br/ ><br>Timepoint: Changes in lesion area on chest CT done during active disease and at end of 14 weeks. <br/ ><br>2)Changes in resting finger pulse oximetry readings at 4 weekly intervals upto 14 weeks. <br/ ><br>3) Changes in Post 6 minute walk pulseoximetry readings at 4 weekly intervals upto 14 weeks. <br/ ><br>4)Changes in spirometry findings at 4 weekly intervals upto 14 weeks. <br/ ><br> <br/ ><br>