A comparison of high dose steroid and tocilizumab in COVID ARDS

Not Applicable

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2021/04/033263
• Lead Sponsor: Post Graduate Institute of Medical Education and Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients aged 18 years or above of either gender

2.Confirmed SARS-CoV-2 (COVID-19) infection by RT-PCR with PaO2:FIO2 ratio of less than 200 on admission

3.Use of one of the following for hypoxia:

a.Oxygen supplementation with an oxygen flow of at least 10 L/min independent of delivery system

b.Non-invasive ventilation or HFNC OR

c.Invasive mechanical ventilation

4.Within 48 hrs of initiation of standard therapy if

a.PaO2:FIO2 ratio worsens by more than 50 from baseline value and

b.Oxygenation or ventilation device is upgraded and

c.Increasing or static CRP

5.Imaging with chest X-ray/CT-Chest suggestive of COVID 19 related lung opacities.

6.Signature of informed consent by the patient, family member or legal representative

Exclusion Criteria

1.known history of dexamethasone or Tocilizumab allergy

2.Prior history of immunosuppression and use of immunosuppressive drugs

3.Use of corticosteroids for indications other than COVID-19

4.Invasive fungal infection

5.Active tuberculosis

6.Liver injury or failure (AST/ALT >= 5x Upper limit of normal)

7.Leukocytes < 2 � 103/μl

8.Thrombocytes < 50 � 103/μl

9.Severe bacterial infection (Procalcitonin > 3ng/ml)

10. Acute or chronic diverticulitis

11.unwilling or unable to participate or complete the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified