MedPath

A comparative study of High dose corticosteroids pulse versus standard of care in severe COVID19 pneumonia

Phase 2
Conditions
Health Condition 1: B342- Coronavirus infection, unspecified
Registration Number
CTRI/2021/05/033523
Lead Sponsor
Post Graduate Institute of Medical Sciences PGIMS Rohtak
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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