The Use of Tocilizumab in the Management of Patients Who Have Severe COVID-19 With Suspected Pulmonary Hyperinflammation
NCT ID: NCT04377750
Last Updated: 2020-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
500 participants
INTERVENTIONAL
2020-04-08
2021-05-08
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tocilizumab treatment group
Treatment: intravenous administration of monoclonal anti body anti- IL6R. The dose is 8 mg/kg up to total dose of 800 mg.
Tocilizumab
The placebo treatment arm will include 100 ml of normal saline administered along 60 min
Placebo group
Placebo. intravenous administration of 100 ml of normal saline.
Tocilizumab
The placebo treatment arm will include 100 ml of normal saline administered along 60 min
Interventions
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Tocilizumab
The placebo treatment arm will include 100 ml of normal saline administered along 60 min
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Sheba Medical Center
OTHER_GOV
Wolfson Medical Center
OTHER_GOV
Hadassah Medical Organization
OTHER
Responsible Party
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Principal Investigators
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Juli Benbenisty, MPH
Role: STUDY_CHAIR
Hadassah Medical Organization
Locations
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Hadassah Medical Orginisation
Jerusalem, Please Select:, Israel
Barzilai Medical Center
Ashkelon, , Israel
Wolfson Medical Center
Holon, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0224-20-HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id
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