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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04377750
Recruitment Status : Unknown
Verified April 2020 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : May 6, 2020
Last Update Posted : May 6, 2020
Sponsor:
Collaborators:
Sheba Medical Center
Wolfson Medical Center
Information provided by (Responsible Party):
Hadassah Medical Organization

Study Description
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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.


Condition or disease Intervention/treatment Phase
Covid19 Pneumonia Drug: Tocilizumab Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Tocilizumab in the Management of Patients Who Have Severe COVID-19 With Suspected Pulmonary Hyperinflammation
Actual Study Start Date : April 8, 2020
Actual Primary Completion Date : April 29, 2020
Estimated Study Completion Date : May 8, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Tocilizumab
The placebo treatment arm will include 100 ml of normal saline administered along 60 min
Other Name: Placebo
Placebo Comparator: Placebo group
Placebo. intravenous administration of 100 ml of normal saline.
 Drug: Tocilizumab
The placebo treatment arm will include 100 ml of normal saline administered along 60 min
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Survival [ Time Frame: One-month ]
    One-month mortality rate .


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04377750


Contacts
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Contact: Reuven Pizov, Prof. 972-50-6265542 pizovr@hadassah.org.il
Contact: Eithan Galun, Prof. 972-2-6777762 eithang@hadassah.org.il

Locations
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Israel
Hadassah Medical Orginisation Recruiting
Jerusalem, Please Select:, Israel, 91120
Contact: Eithan Galun, Prof.    972-2-6777762    eithang@hadassah.org.il   
Barzilai Medical Center Recruiting
Ashkelon, Israel
Contact: Shlomo Maayan, PROF    972-5-37678965    shlomomom@bmc.gov.il   
Wolfson Medical Center Recruiting
H̱olon, Israel
Contact: Yasmin Meir, Dr.    972-5-26666194    yasminm@wmc.gov.il   
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Galia Rahav, Prof.    972-5-526666190    galia.rahav@sheba.health.gov.il   
Sponsors and Collaborators
Hadassah Medical Organization
Sheba Medical Center
Wolfson Medical Center
Investigators
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Study Chair: Juli Benbenisty, MPH Hadassah Medical Organization
More Information
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Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT04377750    
Other Study ID Numbers: 0224-20-HMO-CTIL
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hadassah Medical Organization:
SARS-CoV-2
Cytokine storm
IL-6
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases