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

NCT04377750 | Unknown Phase 4 DMC

• 1 other identifier: 0224-20-HMO-CTIL
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 4

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.

Conditions

Covid19 Pneumonia

Keywords

SARS-CoV-2; Cytokine storm; IL-6

Outcome Measures

Primary Outcomes (1)

• Survival

  One-month mortality rate .

  One-month

Study Arms (2)

Tocilizumab treatment group

EXPERIMENTAL

Treatment: intravenous administration of monoclonal anti body anti- IL6R. The dose is 8 mg/kg up to total dose of 800 mg.

Drug: Tocilizumab

Placebo group

PLACEBO COMPARATOR

Placebo. intravenous administration of 100 ml of normal saline.

Drug: Tocilizumab

Interventions

Tocilizumab DRUG

The placebo treatment arm will include 100 ml of normal saline administered along 60 min

Also known as: Placebo

Placebo group; Tocilizumab treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Sheba Medical Center: collaborator
• Wolfson Medical Center: collaborator

Study Sites (4)

Hadassah Medical Orginisation

Jerusalem, Please Select:, 91120, Israel

RECRUITING

Barzilai Medical Center

Ashkelon, Israel

RECRUITING

Wolfson Medical Center

Holon, Israel

RECRUITING

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Cytokine Release Syndrome

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Juli Benbenisty, MPH

  Hadassah Medical Organization

  STUDY CHAIR

Central Study Contacts

Reuven Pizov, Prof.

CONTACT

972-50-6265542; pizovr@hadassah.org.il

Eithan Galun, Prof.

CONTACT

972-2-6777762; eithang@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: May 6, 2020
• Study Start: April 8, 2020
• Primary Completion: April 29, 2020
• Study Completion: May 8, 2021
• Last Updated: May 6, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (4)