A prospective, randomized, double blinded placebo-controlled trial to evaluate the efficacy and safety of tocilizumab in patients with severe COVID-19 pneumonia

Phase 2

• Conditions: COVID-19, SARS-CoV2, Corona-Virus; U07.1; COVID-19, virus identified

• Registration Number: DRKS00021238
• Lead Sponsor: niversitätsklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Proof of SARS-CoV2
Severe respiratory failure
- ambient air SpO2 = 92% or
- Need of = 6l O2/min or
- NIV or IMV

Exclusion Criteria

1. Invasvie or non-invasive mechanical ventilation = 48 hours
2. pregnancy or lactation period
3. Liver injury or failure (AST/ALT = 5x above normal)
4. Leucocytes < 2 × 10^3/µl
5. Thrombocytes < 50 × 10^3/µl
6. severe bacterial infection (PCT > 3ng/ml)
7. rheumatoid arthritis
8. Immunosuppressive therapy
9. Known tuberculosis
10. Known active or chronic viral hepatitis
11. Allergic reactions to Tocilizumab or its ingredients
12. Life expaction of less then 1 year (independent of Covid-19)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ventilator free days (in the first 28 days)

Secondary Outcome Measures

Name	Time	Method
Mortality<br>- 28-day mortality (%)<br>- hospital mortality (%)<br>Admission to ICU (%)<br>Days on ICU (d)<br>Ventilator freee days (without NIV) (d)<br>Renal failure and dialysis (%)<br>Change of ventilation mode and invasivity<br>- Horrowitz Index (PaO2/FiO2)<br>- fiO2 on NIV/IMV<br>- fiO2 on O2-Maske/Highflow-Therapie<br>- PEEP und Compliance on NIV/IMV<br>SOFA-Score<br>Seven-Scale Category<br>Treatment safety