Tocilizumab plus background therapy versus placebo plus background therapy in patients with severe COVID-19 pneumonia.

Phase 1

• Conditions: Severe COVID-19 pneumonia; MedDRA version: 21.1Level: PTClassification code 10035737Term: Pneumonia viralSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001154-22-DE
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-26
• Last Update Posted: 25 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 360

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
- Platelet count < 50,000/mm3
- ALT or AST > 10 x ULN
- Treatment with an investigational drug within 5 half-lives or 30 days
- Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator’s judgment, precludes the patient’s safe participation in and completion of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective for this study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of TCZ compared with placebo in combination with SOC for the treatment of severe COVID-19 pneumonia;Secondary Objective: Not applicable ;Primary end point(s): The primary efficacy endpoint is Clinical status assessed using a 7-category ordinal scale.<br>;Timepoint(s) of evaluation of this end point: at Day 28

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary efficacy endpoints are:<br>1. Time to clinical improvement<br>2. Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status<br>3. Incidence of mechanical ventilation<br>4. Ventilator-free days<br>5. Incidence of intensive care unit (ICU) stay<br>6. Duration of ICU stay<br>7. Time to clinical failure<br>8. Mortality rate<br>9. Time to hospital discharge or ready for discharge<br>10. Duration of supplemental oxygen.;Timepoint(s) of evaluation of this end point: Throughout the trial up to Day 60.