Covid19 Pneumonia
Conditions
Keywords
SARS-CoV-2, Cytokine storm, IL-6
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.
Interventions
DRUGTocilizumab
The placebo treatment arm will include 100 ml of normal saline administered along 60 min
Sponsors
Sheba Medical Center
Wolfson Medical Center
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | One-month | One-month mortality rate . |
Countries
Israel
Contacts
Primary ContactReuven Pizov, Prof.
Backup ContactEithan Galun, Prof.
Outcome results
None listed