Overview

The Use of Tocilizumab in the Management of Patients Who Have Severe COVID-19 With Suspected Pulmonary Hyperinflammation

Status:
Recruiting
Trial end date:
2021-05-08
Target enrollment:
0
Participant gender:
All
Summary
Title: The use of Tocilizumab in the management of patients who have severe COVID-19 with suspected pulmonary hyperinflammation. This is a study designed to assess the therapeutic value of intravenous tocilizumab administered as single 8mg/Kg dose in patients affected by SARS-CoV2 infection with a pulmonary manifestation causing hypoxia. Aim of the study is to test the hypothesis that anti-IL6 treatment can be effective in reducing the virus-induced cytokine storm, blocking deterioration of lung function or even promoting a rapid improvement of clinical conditions, preventing tracheal intubation and/or death. This drug will be administered to those patients entering the ICU with severe acute respiratory failure COVID-19 disease. The endpoints are death and duration of hospitalization. The patients will be assessed with surrogate markers determining the level of the cytokine storm.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hadassah Medical Organization
Collaborators:
Sheba Medical Center
Wolfson Medical Center
Criteria
Inclusion Criteria:

1. Any gender

2. Age 18 and older

3. Informed consent for participation in the study

4. Virological diagnosis of Sars-CoV2 infection (PCR)

5. Acute respiratory failure

6. Radiographic pneumonia, defined as any/ changing new lung infiltrate

7. Patient breathing spontaneously, required more than 50% oxygen and MEWS score > 7.

8. If intubated, intubated less than 24 hours with PaO2/Fio2 ratio ≤ 200 and PEEP ≥ 5 cm
H2O.

Exclusion Criteria:

1. Known hypersensitivity to tocilizumab or its excipients

2. Patient with a life expectancy of less than 6 months.

3. Known active infections or other clinical condition that contra-indicate tocilizumab
and cannot be treated or solved according to the judgement of the clinician.

4. Neutrophils <500 / mmc

5. Platelets <40.000 / mmc