A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TOCILIZUMAB IN PATIENTS WITH SEVERE COVID-19 PNEUMONIA

Phase 3

Completed

Conditions: inflammation lungs
Pneumonia
respiratory disorder
10024970

Registration Number: NL-OMON50069

Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- Age ><= 18 years
- Hospitalized with COVID-19 pneumonia confirmed per a positive PCR of any
specimen (e.g., respiratory, blood, urine, stool, other bodily fluid) and
evidenced by chest X-ray or CT scan
- SpO2 <<= 93% or PaO2/FiO2 < 300 mmHg.

Exclusion Criteria

- Known severe allergic reactions to TCZ or other monoclonal antibodies
- Active TB infection
- Suspected active bacterial, fungal, viral, or other infection (besides
COVID-19)
- In the opinion of the investigator, progression to death is imminent and
inevitable within the next 24 hours, irrespective of the provision of treatments
- Have received oral anti-rejection or immunomodulatory drugs (including
tocilizumab) within past 3 months
- Pregnant or lactating women
- Participating in other drug clinical trials (with possible exception of
anti-viral trials)
- ANC < 1000/mm3

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Efficacy Objective<br /><br>The primary efficacy objective for this study is to evaluate the efficacy of<br /><br>TCZ compared with<br /><br>placebo in combination with SOC for the treatment of severe COVID-19 pneumonia<br /><br>on the<br /><br>basis of the following endpoint:<br /><br>* Clinical status assessed using a 7-category ordinal scale at Day 28</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Time to clinical improvement<br /><br>2. Time to improvement of at least 2 categories relative to baseline on a<br /><br>7-category ordinal scale of clinical status<br /><br>3. Incidence of mechanical ventilation<br /><br>4. Ventilator-free days<br /><br>5. Incidence of intensive care unit (ICU) stay<br /><br>6. Duration of ICU stay<br /><br>7. Time to clinical failure<br /><br>8. Mortality rate<br /><br>9. Time to hospital discharge or ready for discharge<br /><br>10. Duration of supplemental oxygen.</p><br>