Status:
UNKNOWN
The Use of Tocilizumab in the Management of Patients Who Have Severe COVID-19 With Suspected Pulmonary Hyperinflammation
Lead Sponsor:
Hadassah Medical Organization
Collaborating Sponsors:
Sheba Medical Center
Wolfson Medical Center
Conditions:
Covid19 Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 intravenou...
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 trea...
Eligibility Criteria
Inclusion
- Any gender
- Age 18 and older
- Informed consent for participation in the study
- Virological diagnosis of Sars-CoV2 infection (PCR)
- Acute respiratory failure
- Radiographic pneumonia, defined as any/ changing new lung infiltrate
- Patient breathing spontaneously, required more than 50% oxygen and MEWS score \> 7.
- If intubated, intubated less than 24 hours with PaO2/Fio2 ratio ≤ 200 and PEEP ≥ 5 cm H2O.
Exclusion
- Known hypersensitivity to tocilizumab or its excipients
- Patient with a life expectancy of less than 6 months.
- Known active infections or other clinical condition that contra-indicate tocilizumab and cannot be treated or solved according to the judgement of the clinician.
- Neutrophils \<500 / mmc
- Platelets \<40.000 / mmc
Key Trial Info
Start Date :
April 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 8 2021
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04377750
Start Date
April 8 2020
End Date
May 8 2021
Last Update
May 6 2020
Active Locations (4)
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1
Hadassah Medical Orginisation
Jerusalem, Please Select:, Israel, 91120
2
Barzilai Medical Center
Ashkelon, Israel
3
Wolfson Medical Center
Holon, Israel
4
Sheba Medical Center
Ramat Gan, Israel