A multicenter randomized trial to evaluate the efficacy of tocilizumab in patients with severe Coronavirus Disease 2019 (Covid-19) pneumonia failing glucocorticoids.

A multicenter randomized trial to evaluate the efficacy of tocilizumab in patients with severe Coronavirus Disease 2019 (Covid-19) pneumonia failing glucocorticoids. - ANTICIPANT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005291-35-IT

Enrollment

640

Registered

2021-03-22

Start date

2021-02-03

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

polmonite severa da coronavirus 2019 MedDRA version: 23.0 Level: LLT Classification code 10053983 Term: Corona virus infection System Organ Class: 100000004862

Interventions

Product Name: tocilizumab Product Code: [DB06273] Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: TOCILIZUMAB CAS Number: 375823-41-9 Current Sponsor code: DB06273 Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • age>= 18 years; • Informed consent for participation in the study; • Polymerase Chain Reaction (Real-time PCR) diagnosis of Sars-CoV2 infection; • Hospitalization; • Clinical/instrumental diagnosis (high resolution chest computed tomography scan or chest x-ray or pulmonary ultrasound) of COVID-19 pneumonia; • PaO2/FiO2 ratio in room air 30 bpm and/or use of accessory respiratory muscles) occurs despite treatment at least 36 hours from first dexamethasone dose. The interval has been chosen on the basis of clinical experience with the timing of clinical improvement after starting this treatment. • An hyperinflammation condition defined by the presence of at least two of the following criteria at any time from admission: a) blood lymphocytes 500ng/mL; c) LDH > 300 U/L; d) D-dimers > 1000 ng/mL; e) Creactive protein > 3mg/dL 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 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

Exclusion criteria: • Patient with acute respiratory distress syndrome with PaO2/FiO2 ratio > 250 mmHg; • Invasive ventilation (oro-tracheal intubation); • Known hypersensitivity to TCZ or its excipients; • Clinical conditions that contraindicate TCZ and cannot be treated or resolved according to the physician's judgment: e.g. Glutamate-pyruvate transaminase (GPT) or glutamine oxaloacetic transaminase (GOT) > 5 times the upper limit of the norm, Neutrophils 0.5 ng/mL

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the efficacy of tocilizumab in preventing intubation or death in patients with COVID-19 severe pneumonia who are deteriorating their respiratory function on glucocorticoids.;Secondary Objective: Valutare la corretta tempistica di somministrazione di tocilizumab. Valutare la sicurezza di tocilizumab dopo glucocorticoidi.;Primary end point(s): The primary endpoint is defined by the occurrence, within 4 weeks of randomization, of one of these 3 events: a)entry into ICU (Intensive Care Unit) with invasive mechanical ventilation; b)death from all causes; c) reaching a PaO2/FiO2 <130 mmHg in room air;Timepoint(s) of evaluation of this end point: 4 weeks	—

Measure

Time frame

Main Objective: Evaluate the efficacy of tocilizumab in preventing intubation or death in patients with COVID-19 severe pneumonia who are deteriorating their respiratory function on glucocorticoids.;Secondary Objective: Valutare la corretta tempistica di somministrazione di tocilizumab. Valutare la sicurezza di tocilizumab dopo glucocorticoidi.;Primary end point(s): The primary endpoint is defined by the occurrence, within 4 weeks of randomization, of one of these 3 events: a)entry into ICU (Intensive Care Unit) with invasive mechanical ventilation; b)death from all causes; c) reaching a PaO2/FiO2 <130 mmHg in room air;Timepoint(s) of evaluation of this end point: 4 weeks

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Countries

Italy

Contacts

Public ContactUfficio Sperimentazioni Cliniche

AOU di Modena

nb.protocolli@unimore.it+390594222604

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026