Efficacy of Early Administration of Tocilizumab in COVID-19 Patients

• Status: Terminated
• Trial end date: 2020-06-06
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Unità Sanitaria Locale Reggio Emilia

Criteria

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