Health Condition 1: B342- Coronavirus infection, unspecified
Conditions
Interventions
Intervention1: pulse steroid arm: Drug - Methylprednisolone,
Dose - 250 mg,
Route - Intravenously,
Frequency - once a day,
Duration - for 3 days after randomization
Control Intervention1: standard
Sponsors
Post Graduate Institute of Medical Sciences PGIMS Rohtak
Eligibility
Inclusion criteria
Inclusion criteria: COVID19 confirmed case (with nasal or oral swab RT-PCR or rapid antigen positive). Chest radiograph suggestive of pneumonia. Severity scale according to WHO ordinal scale score of either 4 or 5 or 6 (oxygen requirement or HFNC requirement or NIV requirement or invasive mechanical ventilation). Able to and willing to provide informed consent.
Exclusion criteria
Exclusion criteria: Patients belonging to category 7 (requiring ECMO or vasopressor support). Pregnant subjects. Patients participating in other clinical trials. Known case of any psychiatric illness. Treating physician assessed high likelihood of mortality in 72 hours of randomization. Subjects who have received steroids dose of over 0.4 mg/kg/day of dexamethasone or 2mg/kg/day of methylprednisolone for over 2 day in past 14 days. Co-existing condition mandating the use of high dose steroids. Life threatening comorbidities like a. CKD requiring dialysis. b. Life threatening new onset arrythmia. c. Hypotension. d. Evidence or suspicion of active bacterial infection. e. Evidence or suspicion of acute onset renal or liver failure f. Child C category of chronic liver disease. g. Co-existing autoimmune disease requiring immunosuppressive drugs. h. Concurrent use of tocilizumab/baricitinib/itolizumab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy end point will be time to recovery where recovery is defined as fall of 2 points in WHO 8-point ordinal scale or liberation from oxygen therapy.Timepoint: 0, 3rd, 7th, 14th, 28th day | — |
Secondary
| Measure | Time frame |
|---|---|
| Delay in viral clearance (time taken for RT PCR to be negative)Timepoint: 0, 7th, 14th, 28th day;Duration of Hospital StayTimepoint: 0, 3rd, 7th, 14th, 28th day;Duration of ICU stayTimepoint: 0, 3rd, 7th, 14th, 28th day;Mortality at 28 daysTimepoint: 0, 3rd, 7th, 14th, 28th day;Safety outcomes: a. Incidence of secondary infections b. New onset hyperglycaemia or worsening of sugar control. c. Treatment emergent adverse events according to CTCAE version 5 Timepoint: 0, 3rd, 7th, 14th, 28th day | — |
Countries
India
Contacts
Public ContactDhruva Chaudhry
Pt. B.D. Sharma PGIMS, Rohtak
Outcome results
None listed