Clazakizumab (Anti-Interleukin 6 (IL-6) Monoclonal) Compared to Placebo for Coronavirus Disease 2019 (COVID-19)

NCT04348500 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 00000644
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, randomized, double-blind, placebo-controlled, exploratory phase II study enrolling 60 patients. We propose the administration of a blinded dose of an investigational product (IP) (clazakizumab or placebo \[0.9% saline\]) in patients with COVID-19 disease and signs of pulmonary involvement who have not yet required mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO). If a patient progresses to mechanical ventilation and/or ECMO or develops clinical signs of deteriorating COVID-19 disease, and there are no treatment related serious adverse events (SAEs), within the initial 14 day period after the first dose of the IP, at the discretion of the investigator or treating physician, open-label clazakizumab 25mg IV x 1 dose may be administered. A minimum of 24 hours should elapse between the first dose of IP and this dose of open-label clazakizumab. The patient will remain blinded as to the identity of the IP administered in the first dose.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Safety of Clazakizumab for the Treatment of Patients With COVID-19 Disease

  Number of severe adverse events (SAEs) that are unusual, unexpected, or assessed as related to the investigational product (IP)

  14 days

Secondary Outcomes (6)

• Patient Survival at 28 Days

  28 days

• Patient Survival at 60 Days

  60 days

• Number of Patients Requiring the Dose of Open-label Clazakizumab

  14 days

• Number of Days in Intensive Care Unit (ICU)

  60 days

• Number of Days in Hospital

  60 days

Study Arms (2)

Clazakizumab

ACTIVE COMPARATOR

25 mg in 50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes

Drug: Clazakizumab

Placebo

PLACEBO COMPARATOR

50 mL of 0.9% saline given by IV infusion x 1 dose over 30 minutes

Drug: Clazakizumab

Interventions

Clazakizumab DRUG

IV Infusion

Clazakizumab; Placebo

Eligibility Criteria

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

You may qualify if:

• Age \>18 at the time of screening
• Subject must be able to understand and provide informed consent
• Hospitalized with COVID-19 (+) disease (confirmed by polymerase chain reaction (PCR) assay from any specimen (e.g. respiratory, blood, urine, stool, other bodily fluid))
• Not on mechanical ventilation and/or ECMO
• Evidence of pulmonary involvement with at least 2 of the following:
• Oxygen saturation (SpO2) at rest in ambient air with SpO2 ≤ 94%
• Tachypnea with resting respiration rate \> 25 breaths/minute
• Partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2) ≤ 300 mmHg
• Chest imaging (radiograph, CT scan, or lung ultrasound) with abnormalities consistent COVID-19 pneumonia
• C-reactive protein (CRP) \>35 mg/L

You may not qualify if:

• Previous hypersensitivity or allergic reactions to clazakizumab
• Lactating or pregnant females
• Subjects with latent Tuberculosis (TB) and who are not receiving treatment
• Subjects with active TB
• A significantly abnormal general serum screening lab result defined as a White Blood Count (WBC) \< 3.0 X 103/ml, a Hgb \< 8.0 g/dL, a platelet count \< 50 X 103/ml, a serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) \> 5x upper limit normal
• Participation in another clinical trial investigating COVID-19 aimed agents

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

clazakizumab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Due to the small sample size, unable to assess statistical significance between the treatment and placebo group.

Results Point of Contact

• Title: Dr. Stanley C. Jordan, MD
• Organization: Cedars Sinai Medical Center

sjordan@cshs.org

310-423-2641

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded IP (clazakizumab or placebo) will be given initially, followed by the option of an open label dose of clazakizumab within the first 14 days of initial IP administration.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nephrology and Transplant Immunology

Model Details: We propose the administration of a blinded dose of an investigational product (IP) (clazakizumab or placebo \[0.9% saline\]) in patients with COVID-19 disease and signs of pulmonary involvement who have not yet required mechanical ventilation and/or ECMO. If a patient progresses to mechanical ventilation and/or ECMO or develops clinical signs of deteriorating COVID-19 disease, and there are no treatment related serious adverse events (SAEs), within the initial 14 day period after the first dose of the IP, at the discretion of the investigator or treating physician, open-label clazakizumab 25mg IV x 1 dose may be administered. A minimum of 24 hours should elapse between the first dose of IP and this dose of open-label clazakizumab. The patient will remain blinded as to the identity of the IP administered in the first dose.

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 16, 2020
• Study Start: April 28, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: February 8, 2024
• Results First Posted: December 2, 2021

Record last verified: 2024-02

Locations

US (1)