Study of Edaravone as adjunctive treatment in COVID

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2020
INTERVENTION: 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 Placebo: Standard of care for COVID disease as per ICMR guidelines And Placebo will have Normal Saline IV infusion over one hour for seven days CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: 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 OUTCOME: 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. ; ; INCLUSION CRITERIA: Male and female above 18 years till 65 years with moderate COVID Disease
Epistemonikos ID: 5adbedf9db1193ade4cda62bad97a0bdf9647c2c
First added on: Dec 17, 2020