The use of tocilizumab in patients with severe COVID 19 pneumonia - a trial to know its efficacy in those on steroids

Phase 3

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

• Registration Number: CTRI/2020/12/029793
• Lead Sponsor: aveen Naik B

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 18 years or older

2.Diagnosis of SARS-CoV-2 infection by RT-PCR

3.Pulmonary infiltrates on CXR/ CECT Chest

4.On COVID specific steroid therapy with IV methyl prednisolone 1 mg/kg/day or dexamethasone 6 mg per day

5.Severe respiratory failure with PaO2 / FiO2 less than 150 mmHg and IL-6 > 50 pg/mL with CRP > 50 mg/L

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

Exclusion Criteria

1.Less than 24 hrs of initiation of steroid therapy

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

3. Leukocytes < 2 � 103/μl

4. Thrombocytes < 50 � 103/μl

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

6. Acute or chronic diverticulitis

7. Immunosuppressive therapy (e.g. mycophenolate, azathioprine, methotrexate and biologicals)

8. Known active or chronic tuberculosis

9. Known active or chronic viral hepatitis

10. Known allergic reactions to tocilizumab or its ingredients

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ventilator free days (VFD) in the first 28 days, after randomisationTimepoint: 28 days after randomisation

Secondary Outcome Measures

Name	Time	Method
28-day mortality (%) <br/ ><br>Remission of respiratory symptoms <br/ ><br>Time to clinical improvement (Time frame: 28 days, after randomization) <br/ ><br>Days in ICU <br/ ><br>Invasive mechanical ventilation free days <br/ ><br>Change of ventilation mode and invasiveness <br/ ><br>Radiological response or improvement <br/ ><br>Levels of procalcitonin, CRP, IL-6, Ferritin and D-Dimers <br/ ><br>and their correlation with the treatment effectiveness <br/ ><br>Renal function <br/ ><br>SOFA-Score <br/ ><br>APACHE-II Score <br/ ><br>Duration of hospitalization <br/ ><br>Murray lung score <br/ ><br>7 point scale <br/ ><br>Timepoint: ICU stay and 28 days after randomization <br/ ><br>