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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04348500
Recruitment Status : Not yet recruiting
First Posted : April 16, 2020
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
Stanley Jordan, MD, Cedars-Sinai Medical Center

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 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.

Condition or disease Intervention/treatment Phase
COVID19 Drug: Clazakizumab Phase 2

Detailed Description:

Patients admitted to 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 for improvements in clinical symptoms and laboratory parameters which are part of our COVID-19 lab panel described below. Patients will receive SOC supportive treatment and will be followed for 14 days. If a patient from either group progresses to the need for mechanical ventilation and/or ECMO, or develops clinical signs of deteriorating COVID-19 disease, and there are no serious treatment related SAEs, at the discretion of the investigator or treating physician, the patient may receive a single dose of open-label clazakizumab 25mg IV. A minimum of 24 hours should elapse between the first dose of IP and this dose of open-label clazakizumab.

Enrolled patients will receive clazakizumab 25 mg or placebo (0.9% saline) given by IV infusion over 30 minutes. Clazakizumab will be administered in 50 mL of 0.9% saline on Day 1.

COVID-19 lab panel and clinical parameters will be monitored to determine if patients are progressing towards need for ventilation and/or ECMO. The parameters below will be monitored and patient status will be assessed by the clinical team.

If patients do develop these criteria, open-label clazakizumab 25 mg IV may be administered as discussed above. A minimum of 24 hours should elapse between the first dose of IP and this dose of open-label clazakizumab. Patients ventilated with or without ECMO will continue to be monitored post-treatment for signs of improvement, (i.e., decreasing FiO2 requirements, CXR improvements, CRP reductions, extubation and discharge home) or death.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Primary Purpose: Treatment
Official Title: A Phase II Trial to Evaluate the Safety and Tolerability of Clazakizumab® (Anti-IL- 6 Monoclonal) Compared to Placebo for the Treatment of COVID-19 Infection
Estimated Study Start Date : April 21, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

Arm Intervention/treatment
Active Comparator: Clazakizumab
25 mg in 50 cc NS given by IV infusion x 1 dose
Drug: Clazakizumab
Infusion

Placebo Comparator: Placebo
50 cc NS given by IV infusion x 1 dose
Drug: Clazakizumab
Infusion




Primary Outcome Measures :
  1. Evaluate the safety and efficacy of clazakizumab for the treatment of patients with COVID-19 disease and signs of pulmonary involvement [ Time Frame: 14 days ]
    Incidence of need for mechanical ventilation and/or ECMO at 14 days after the first administered dose in comparison to placebo


Secondary Outcome Measures :
  1. Patient survival at 28 days [ Time Frame: 28 days ]
    Number of patients alive at 28 days

  2. Patient survival at 60 days [ Time Frame: 60 days ]
    Number of patients alive at 60 days

  3. Number of patients requiring the dose of open-label clazakizumab [ Time Frame: 14 days ]
    Number of patients requiring the dose of open-label clazakizumab

  4. Reduced duration of intensive care unit stay [ Time Frame: 60 days ]
    Number of days in ICU compared to placebo

  5. Reduced duration of hospital stay [ Time Frame: 60 days ]
    Number of days in hospital compared to placebo



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04348500


Contacts
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Contact: Noriko Ammerman, PharmD 310-248-8186 noriko.ammerman@cshs.org

Sponsors and Collaborators
Cedars-Sinai Medical Center
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Responsible Party: Stanley Jordan, MD, Staff Physician III, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT04348500    
Other Study ID Numbers: 00000644
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No