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

Detailed Description

Study design This is a multicenter, two arms, 2:1 (treatment: control) open-label randomized
control study with a drug approved for another indication in Israel. All the patients
enrolled will be treated with tocilizumab or not. One-month mortality rate is the primary
endpoint. One arm will be the study drug anti-IL6R (Tocilizumab (Actmera)) 8 mg/kg given IV
during one hour once. The placebo will be a 100 ml saline IV infusion administered along one
hour.

Unknown status
COVID19 Pneumonia

Drug: Tocilizumab

The placebo treatment arm will include 100 ml of normal saline administered along 60 min
Other Name: Placebo

Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Israel
Locations

Hadassah Medical Orginisation
Jerusalem, Please Select:, Israel

Barzilai Medical Center
Ashkelon, Israel

Wolfson Medical Center
H̱olon, Israel

Sheba Medical Center
Ramat Gan, Israel

Contacts

Reuven Pizov, Prof.
972-50-6265542
pizovr@hadassah.org.il

Eithan Galun, Prof.
972-2-6777762
eithang@hadassah.org.il

Juli Benbenisty, MPH, Study Chair
Hadassah Medical Organization

Hadassah Medical Organization
NCT Number
Keywords
SARS-CoV-2
Cytokine storm
IL-6
MeSH Terms
COVID-19