Phase 2
N=17
Clazakizumab (Anti-Interleukin 6 (IL-6) Monoclonal) Compared to Placebo for Coronavirus Disease 2019 (COVID-19)
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04348500 ↗Enrolled (actual)
17
Serious AEs
31.3%
Results posted
Dec 2021
Primary outcome: Primary: Safety of Clazakizumab for the Treatment of Patients With COVID-19 Disease — 3; 3; 6; 8 Adverse Events — p=0.10
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Clazakizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of Clazakizumab for the Treatment of Patients With COVID-19 Disease |
3; 3; 6; 8 | 0.10 |
| SECONDARY Patient Survival at 28 Days |
7; 7 | — |
| SECONDARY Patient Survival at 60 Days |
6; 6 | — |
| SECONDARY Number of Patients Requiring the Dose of Open-label Clazakizumab |
2; 5 | — |
| SECONDARY Number of Days in Intensive Care Unit (ICU) |
30.5; 11.67 | — |
| SECONDARY Number of Days in Hospital |
17.5; 18.75 | — |
| SECONDARY Number of Patients Requiring Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) |
1; 2 | 0.10 |
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:
- 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 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) 5x upper limit normal
- Participation in another clinical trial investigating COVID-19 aimed agents
Data sourced from ClinicalTrials.gov (NCT04348500). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.