Efficacy of Early Administration of Tocilizumab in COVID-19 Patients

Phase 2TerminatedNCT04346355

Azienda USL Reggio Emilia - IRCCS126 enrolled

Overview

The clinical study aims at assessing whether early administration of Tocilizumab compared to late administration of Tocilizumab can reduce the number of patients with COVID-19 pneumonia who require mechanical ventilation. The clinical study includes patients with recent-onset COVID-19 pneumonia who require hospital care, but not invasive or semi-invasive mechanical ventilation procedures.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

126

Conditions

COVID-19 Pneumonia

Interventions

TocilizumabDRUG

In case of aggravation of COVID-19 pneumonia, according to protocol criteria, participants will receive 8 mg/kg IV up to a maximum of 800 mg with repetition of the same dosage after 12 hours

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age \> 18 years * Informed consent for participation in the study * Real time polymerase chain reaction (PCR) diagnosis of Sars-CoV2 infection * Hospitalization due to clinical / instrumental diagnosis (high resolution chest CT scan or chest x-ray or pulmonary ultrasound) * Presence of acute respiratory distress syndrome with arterial partial pressure of oxygen / fraction of inspired oxygen (PaO2 / FiO2) between 200 and 300 mm/Hg * Presence of exaggerated inflammatory response defined by the presence of at least 1 of the following criteria: * At least one body temperature measurement \>38° C in the past two days; * Serum CRP greater than or equal to 10 mg/dl; * CRP increase of at least twice the basal value Exclusion Criteria: * Patients with respiratory distress syndrome with arterial partial pressure of oxygen / fraction of inspired oxygen (PaO2 / FiO2) \<200 mm/Hg or * Patients in non-invasive ventilation or * Patients in invasive ventilation or presence of shock or presence of concomitant organ failure that requires admission to the Intensive Care Unit * Severe heart and kidney failure * Pregnant or breastfeeding patient * Patient who, in the opinion of the clinician or by the patient's express will, will not go to intensive care regardless of the evolution of the lung picture. * Known hypersensitivity to TCZ or its excipients * Patient being treated with immuno-depressors or anti-rejection drugs * Known active infections or other clinical conditions that contraindicate TCZ and cannot be treated or resolved according to the physician's judgment * glutamate-pyruvate transaminase (GPT) or glutamine oxaloacetic transaminase (GOT) \> 5 times the upper limit of the norm * Neutrophils \<500 /mmc * Platelets \<50.000 /mmc * Diverticulitis or intestinal perforation * Suspicion of latent tuberculosis

Locations (25)

Ospedale di Guastalla

Guastalla, RE, Italy

Outcomes

Primary Outcomes

Entry into Intensive Care with invasive mechanical ventilation or death from any cause or clinical aggravation

Entry into Intensive Care with invasive mechanical ventilation or death from any cause or clinical aggravation documented by the finding of a PaO2 / FiO2 ratio \<150mm / Hg confirmed by a second arterial blood gas (ABG) measurement within four hours

Time frame: two weeks from participants' allocation to study arm