Clazakizumab (Anti-Interleukin 6 (IL-6) Monoclonal) Compared to Placebo for Coronavirus Disease 2019 (COVID-19)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Clazakizumab
Intervention description: IV Infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: 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.
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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:

               1. Oxygen saturation (SpO2) at rest in ambient air with SpO2 ≤ 94%

               2. Tachypnea with resting respiration rate > 25 breaths/minute

               3. Partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2) ≤ 300 mmHg

               4. Chest imaging (radiograph, CT scan, or lung ultrasound) with abnormalities
                  consistent COVID-19 pneumonia

               5. C-reactive protein (CRP) >35 mg/L

        Exclusion Criteria:

          -  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