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

Covid19 Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04377750
• Other study ID #: 0224-20-HMO-CTIL
• Status: Recruiting
• Phase: Phase 4
• Start date: April 8, 2020
• Est. completion date: May 8, 2021

Study information

• Verified date: April 2020
• Source: Hadassah Medical Organization
• Contact: Reuven Pizov, Prof.
• Phone: 972-50-6265542
• Email: pizovr[@]hadassah.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 8, 2021
• Est. primary completion date: April 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19 Pneumonia
• Pneumonia

Intervention

Drug:
• Tocilizumab
The placebo treatment arm will include 100 ml of normal saline administered along 60 min

Locations

Country	Name	City	State
Israel	Barzilai Medical Center	Ashkelon
Israel	Wolfson Medical Center	H_olon
Israel	Hadassah Medical Orginisation	Jerusalem	Please Select:
Israel	Sheba Medical Center	Ramat Gan

Sponsors (3)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Sheba Medical Center, Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	One-month mortality rate .	One-month