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.
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.
Drug: Tocilizumab
The placebo treatment arm will include 100 ml of normal saline administered along 60 min
Other Name: Placebo
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
Hadassah Medical Orginisation
Jerusalem, Please Select:, Israel
Barzilai Medical Center
Ashkelon, Israel
Wolfson Medical Center
H̱olon, Israel
Sheba Medical Center
Ramat Gan, Israel
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