Clazakizumab (Anti-IL- 6 Monoclonal) Compared to Placebo for COVID19 Disease

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cedars-Sinai Medical Center

Criteria

Inclusion Criteria:

• Age >18 at the time of screening.

• Subject must be able to understand and provide informed consent.

• Hospitalized with COVID19+ disease (confirmed by 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 at rest in ambient air with SpO2 ≤ 94%

2. tachypnea with resting respiration rate > 25 breaths/minute

3. PaO2/FiO2 ≤ 300 mmHg

4. Chest imaging (radiograph, CT scan, or lung ultrasound) with abnormalities consistent COVID-19 pneumonia

5. CRP >35 mg/L

Exclusion Criteria:

• Previous hypersensitivity or allergic reactions to clazakizumab

• Lactating or pregnant females.

• Subjects with latent TB and who are not receiving treatment.

• Subjects with active TB

• A significantly abnormal general serum screening lab result defined as a WBC < 3.0 X 103/ml, a Hgb < 8.0 g/dL, a platelet count < 50 X 103/ml, an SGOT or SGPT > 5X upper limit normal

• Participation in another clinical trial investigating COVID-19 aimed agents