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Clazakizumab vs. Placebo - COVID-19 Infection

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ClinicalTrials.gov Identifier: NCT04494724
Recruitment Status : Recruiting
First Posted : July 31, 2020
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
The Methodist Hospital Research Institute

Brief Summary:
The purpose of this study is to investigate the effectiveness and safety of treatment with clazakizumab compared to a placebo (inactive substance). We are proposing to try this drug to treat coronavirus disease 2019 (COVID-19) infection. Patients with COVID-19 infection have been shown to have increases in certain inflammatory processes. Clazakizumab is an antibody (immune system protein) that blocks certain inflammatory processes. The treatment plan is to attempt to inhibit or block these inflammatory processes in order to try to limit the damage COVID-19 causes to the lungs.

Condition or disease Intervention/treatment Phase
COVID-19 Infection Drug: Clazakizumab Drug: Placebo Phase 2

Detailed Description:

The purpose of this randomized, double-blind, placebo-controlled trial is to evaluate the safety and efficacy of clazakizumab vs placebo for the prevention of acute respiratory distress syndrome (ARDS) in patients with COVID-19 and pulmonary manifestations. The study will compare clazakizumab to placebo in a randomized, double-blind fashion followed by an open-label dose of clazakizumab if there is no improvement or a worsening of condition occurs after 24-hours or anytime during the first 14 days after the first dose of clazakizumab or placebo. We hypothesize that clazakizumab will be safely tolerated and will reduce the risk of progression of COVID-19 to acute respiratory distress syndrome.

Primary Objective:

• To evaluate the safety and tolerability of clazakizumab vs placebo for the treatment of patients with COVID-19 disease and signs of pulmonary involvement

Sixty adult patients with COVID-19 and signs of pulmonary involvement at Houston Methodist who are not in need of ventilator support at the time of enrollment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This single-site, phase 2 randomized, double-blind, placebo-controlled trial is designed to administer a single dose of clazakizumab or placebo on day 0. If, after 24 hours or up to 14 days from the first infusion, the participant's condition worsens or does not improve, the investigator may elect to provide a single, open-label dose of clazakizumab regardless of the initial group assignment. All except the investigational pharmacist will remain blinded as to the initial group assignment until data lock.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Blinded to all except investigational pharmacy. Only the optional second infusion, if determined necessary to administer, will be open-label. The patient and study team will remain blinded until data lock at the end of the study.
Primary Purpose: Treatment
Official Title: A Phase 2 Trial to Evaluate the Safety and Tolerability of Clazakizumab® [Anti-Interleukin (IL)-6 Monoclonal] Compared to Placebo for the Treatment of COVID-19 Infection
Actual Study Start Date : July 13, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : July 31, 2021


Arm Intervention/treatment
Experimental: Clazakizumab
Clazakizumab - 25mg in 50 milliliters (mL) of 0.9% saline, IV infusion over 30 minutes.
Drug: Clazakizumab
Infusion

Placebo Comparator: Placebo
Placebo - 50 mL 0.9% saline, IV infusion over 30 minutes.
Drug: Placebo
Infusion




Primary Outcome Measures :
  1. Primary Endpoint [ Time Frame: 24 hours ]
    Proportion of participants who experience treatment-related adverse events (TEAE) ≥ Grade 3 (CTCAE v5.0) during the first 24 hours after infusion of clazakizumab or placebo


Secondary Outcome Measures :
  1. Requirement for mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) [ Time Frame: 14 days ]
    Proportion of participants who need mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) after the first dose of clazakizumab or placebo

  2. Infusion-related reactions during 24 hours from the time of infusion [ Time Frame: 24 hours ]
    Proportion of participants who experience infusion-related reactions during the first 24 hours after infusion of clazakizumab or placebo

  3. Patient survival at 28 days [ Time Frame: 28 days ]
    Proportion of participants alive at day 28 after the first dose of clazakizumab or placebo

  4. Patient survival at 60 days [ Time Frame: 60 days ]
    Proportion of participants alive at day 60 after the first dose of clazakizumab or placebo

  5. Requirement for open-label clazakizumab [ Time Frame: 14 days ]
    Proportion of participants who require an open-label dose of clazakizumab

  6. Time in the intensive care unit (ICU) [ Time Frame: 60 days ]
    Number of days in the ICU following the first dose of clazakizumab or placebo

  7. Time in the hospital [ Time Frame: 60 days ]
    Number of days in the hospital following the first dose of clazakizumab or placebo

  8. Time to mechanical ventilation [ Time Frame: 60 days ]
    Number of days from first dose of clazakizumab or placebo to requiring mechanical ventilation

  9. Clinical status improvement assessed by the World Health Organization (WHO) Clinical Progression Scale at day 14 [ Time Frame: 14 days ]
    Difference in WHO Clinical Progression Scale between clazakizumab and placebo

  10. Clinical status improvement assessed by World Health Organization (WHO) Clinical Progression Scale at day 28 [ Time Frame: 28 days ]
    Difference in WHO Clinical Progression Scale between clazakizumab and placebo

  11. Change in Radiologic Assessment of Lung Edema (RALE) at day 14 [ Time Frame: 14 days ]
    Difference in mean or median change in radiologic assessment of lung edema (RALE) score at day 14 from baseline between clazakizumab or placebo

  12. Change in Radiologic Assessment of Lung Edema (RALE) at day 28 [ Time Frame: 28 days ]
    Difference in mean or median change in radiologic assessment of lung edema (RALE) score at day 28 from baseline between clazakizumab or placebo



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >18 at the time of screening.
  2. Participant or legally authorized representative (LAR) must be able to understand and provide informed consent.
  3. Hospitalized with coronavirus disease (COVID-19) confirmed by polymerase chain reaction (PCR) assay from any specimen (eg, respiratory, blood, urine, stool, other bodily fluid) within the prior 72 hours.
  4. C-reactive protein (CRP) > 3.5 mg/dL
  5. Evidence of pulmonary involvement with at least 2 of the following:

    1. oxygen saturation at rest in ambient air with peripheral capillary oxygen saturation (SpO2) ≤ 94%
    2. tachypnea with resting respiration rate > 25 breaths/minute
    3. Partial pressure of oxygen (PaO2)/initial fraction of inspired oxygen (FiO2) ≤ 300 mmHg
    4. Chest imaging (radiograph, CT, or ultrasound) with abnormalities consistent COVID-19 pneumonia

Exclusion Criteria:

  1. Previous hypersensitivity or allergic reactions to clazakizumab
  2. Lactating or pregnant females
  3. Patients with latent tuberculosis (TB) and who are not receiving treatment
  4. Patients with active TB
  5. Patients with known active inflammatory bowel disease, untreated diverticulitis, or gastrointestinal perforation
  6. Requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
  7. A significantly abnormal general serum screening lab result defined as a white blood cell (WBC) count < 3.0 X 10^3/mL, a hemoglobin (Hgb) < 8.0 g/dL, a platelet count < 50 X 10^3/mL, an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper limit normal
  8. Participation in another clinical trial investigating COVID-19-aimed agents
  9. Presence of any medical or psychosocial condition, which the investigator believes, would hinder adherence to the study requirements.

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): NCT04494724


Contacts
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Contact: Isioma Agboli, MD 713-441-6311 iagboli@houstonmethodist.org
Contact: Darrel Cleere, BSN 713-441-6232 dwcleere@houstonmethodist.org

Locations
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United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Isioma Agboli, MD    713-441-6311    iagboli@houstonmethodist.org   
Contact: Darrel Cleere, BSN    713-441-6232    dwcleere@houstonmethodist.org   
Principal Investigator: Howard J Huang, MD         
Sub-Investigator: Alex Rogers, PharmD         
Sub-Investigator: Ahmad Goodarzi, MD         
Sub-Investigator: Yihad G Youssef, MD         
Sub-Investigator: Simon Yau, MD         
Sub-Investigator: Faisal Zahiruddin, MD         
Sub-Investigator: Linda W Moore, PhD         
Sub-Investigator: Ahmed O Gaber, MD         
Sponsors and Collaborators
The Methodist Hospital Research Institute
Investigators
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Principal Investigator: Howard Huang, MD The Methodist Hospital Research Institute
Publications of Results:

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Responsible Party: The Methodist Hospital Research Institute
ClinicalTrials.gov Identifier: NCT04494724    
Other Study ID Numbers: Pro00025969
First Posted: July 31, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Methodist Hospital Research Institute:
COVID-19
coronavirus infection
respiration, artificial
extracorporeal membrane oxygenation
randomized controlled trial
respiratory distress syndrome, adult
Additional relevant MeSH terms:
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Infection
Communicable Diseases