Status:
COMPLETED
Clazakizumab (Anti-Interleukin 6 (IL-6) Monoclonal) Compared to Placebo for Coronavirus Disease 2019 (COVID-19)
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 (...
Detailed Description
Patients admitted to the hospital with COVID-19 disease with signs of pulmonary involvement will be randomized to receive the anti-IL-6 drug clazakizumab 25mg IV or placebo. Patients will be followed ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2020
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04348500
Start Date
April 28 2020
End Date
September 30 2020
Last Update
February 8 2024
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048