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IC14 (Anti-CD14) Treatment in Patients With SARS-CoV-2 (COVID-19)

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: NCT04391309
Recruitment Status : Not yet recruiting
First Posted : May 18, 2020
Last Update Posted : June 24, 2020
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
Implicit Bioscience

Brief Summary:
This is a multicenter, randomized, double-blind, placebo-controlled phase 2 study of IC14, an antibody to CD14, in reducing the severity of respiratory disease in hospitalized COVID-19 patients.

Condition or disease Intervention/treatment Phase
SARS-CoV2 Biological: IC14 Other: Placebo Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Detailed Description:

The primary objective is to test the efficacy and safety of IC14, an antibody to the CD14 pattern-recognition receptor, in reducing the severity of respiratory disease in patients hospitalized with the SARS-CoV-2 virus, which causes the clinical illness known as COVID-19.

Specific Aim 1. Determine the efficacy and safety of IC14, an anti-CD14 chimeric antibody, in patients hospitalized with respiratory disease due to SARS-CoV-2, in terms of increasing the number of days alive and free of any episodes of acute respiratory failure through Day 22.

Specific Aim 2. Determine whether treatment with the IC14 antibody improves time to improvement in clinical status using an eight-point ordinal scale.

Three hundred patients will be randomized to IC14 (n=150) or placebo (n=150). Study drug will be administered daily on Days 1-4. Study participation will continue for 60 days after enrollment. Remdesivir concomitant therapy will be given.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Double-Blind, Placebo-Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Placebo consists of identical-appearing diluent
Primary Purpose: Treatment
Official Title: Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of Anti-CD14 Treatment in Patients With SARS-CoV-2 (COVID-19)
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: IC14, monoclonal antibody to CD14
150 patients randomized to 4 mg/kg on Day 1, 2 mg/kg on Days 2-4 intravenously
Biological: IC14
4 mg/kg on Day 1, 2 mg/kg on Days 2-4 in normal saline intravenously
Other Name: monoclonal antibody to CD14

Placebo Comparator: Placebo
150 patients randomized to Placebo diluent on Days 1-4 intravenously
Other: Placebo
Normal saline intravenously on Days 1-4
Other Name: Normal saline diluent




Primary Outcome Measures :
  1. Acute respiratory failure [ Time Frame: Day 1-22 ]
    Days alive and free of any episodes of acute respiratory failure through Day 22 defined by need for high-flow nasal cannula, noninvasive positive-pressure ventilation, endotracheal intubation and mechanical ventilation, and extracorporeal membrane oxygenation


Secondary Outcome Measures :
  1. Time to clinical improvement [ Time Frame: Day 1-29 ]
    Defined as time to the first day that a subject is in categories 6, 7, or 8 on the Eight-Point Ordinal Scale. The Eight-Point Ordinal Scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen—requiring ongoing medical care (COVID-19-related or otherwise); 6) Hospitalized, not requiring supplemental oxygen—no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.

  2. Acute respiratory failure [ Time Frame: Days 1-8, 1-15, 1-22, 1-29 ]
    Proportion of patients alive and free of any episode of acute respiratory failure through Days 8, 15, 22, and 29

  3. Invasive mechanical ventilation [ Time Frame: Days 1-8, 1-15, 1-22, 1-29 ]
    Proportion of patients alive and free of invasive mechanical ventilation through Days 8, 15, 22, and 29

  4. Acute respiratory failure [ Time Frame: Days 1-15 and 1-29 ]
    Days alive and free of acute respiratory failure through Days 15 and 29

  5. Invasive mechanical ventilation [ Time Frame: Days 1-15, 1-22, 1-29 ]
    Days alive and free of invasive mechanical ventilation through Days 15, 22, and 29

  6. Hospitalization [ Time Frame: Days 1-29 ]
    Days alive and hospitalized through Day 29

  7. Sequential Organ Failure Assessment [ Time Frame: Days 1-8, 1-15, 1-22 ]
    Change in Sequential Organ Failure Assessment (SOFA) score (range 0 [best] to 24 [worst]) from baseline to Day 8, Day 15, and Day 22

  8. Sequential Organ Failure Assessment [ Time Frame: Days 1-22 ]
    Worst SOFA score from baseline to Day 22

  9. Hospitalization [ Time Frame: Days 1-15, 1-29 ]
    Proportion of patients alive and discharged from the hospital at Days 15 and 29.

  10. Ordinal Scale [ Time Frame: Days 1-29 ]
    Mean change in the eight-point ordinal scale (1 [worst] to 8 [best]) through Day 29

  11. Time to clinical improvement [ Time Frame: Days 1-29 ]
    Time to improvement in one category from baseline using an eight-point ordinal scale (1 [worst] to 8 [best]) through Day 29.

  12. Time to clinical improvment [ Time Frame: Days 1-29 ]
    Time to improvement in two categories from baseline using an eight-point ordinal scale (1 [worst] to 8 [best]) through Day 29.

  13. Time to recovery [ Time Frame: Days 1-29 ]
    Time to recovery through Day 29. Day of recovery is defined as the first day on which the subject satisfies one of categories 6-8 from the ordinal scale.

  14. Change in C-reactive protein [ Time Frame: Day 4 compared to baseline; Day 8 compared to baseline ]
    Change in C-reactive protein in blood on Days 4 and 8 compared to baseline (from normal < 10 mg/L [normal] to >10 mg/L [worse])

  15. Adverse events [ Time Frame: Days 1-60 ]
    Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events

  16. Serious adverse events [ Time Frame: Days 1-60 ]
    Cumulative incidence of serious adverse events



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

Inclusion Criteria:

  1. Signed informed consent form and able to give informed consent
  2. Age 18-75 years
  3. Presence of SARS-CoV-2 infection documented by positive RT-PCR testing or history of positive RT-PCR test for SARS-CoV-2 within 7 days
  4. Radiologic findings compatible with diagnosis of SARS-CoV-2 pulmonary infection with no alternative explanation for the radiologic findings
  5. Hypoxemia as defined by any of the following:

    1. SpO2 ≤94% on room air, or
    2. Requirement for ≥2L/m O2 per standard nasal cannula, but not requiring high-flow nasal cannula (defined as ≥30 L/m)
  6. Women of childbearing potential must have a negative pregnancy test

Exclusion Criteria:

  1. Intubation
  2. Receiving non-invasive positive-pressure ventilation
  3. Receiving invasive mechanical ventilation
  4. Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care other than attempts at resuscitation from cardiac arrest)
  5. Anticipated survival <48 hours
  6. Underlying malignancy or other condition with estimated life expectancy of less than one month
  7. Significant pre-existing organ dysfunction

    1. Lung: Currently receiving home oxygen therapy as documented in medical record
    2. Heart: Pre-existing congestive heart failure defined as an ejection fraction <20% as documented in the medical record
    3. Renal: End-stage renal disease requiring renal replacement therapy
    4. Liver: Severe chronic liver disease defined as Child-Pugh Class C
  8. Presence of co-existing infection, including, but not limited to:

    1. HIV infection not virally suppressed with CD4 counts ≤ 500 cell/mm3)
    2. Active tuberculosis or a history of inadequately treated tuberculosis
    3. Active hepatitis B or hepatitis C viral infection
  9. Ongoing immunosuppression

    1. Solid organ transplant recipient
    2. High-dose corticosteroids (equivalent to >20 mg/prednisone/day) within the past 14 days
    3. Oncolytic drug therapy within the past 14 days
  10. Current treatment, or treatment within 30 days or five half-lives, whichever is longer, with etanercept (Enbrel®), infliximab (Remicade®), adalimumab (Humira®), certolizumab (Cimzia®), golimumab (Simponi®), anakinra (Kineret®), rilonacept (Arcalyst®), tocilizumab (Actrema®), sarilumab (Kevzara®), siltuximab (Sylvant®), or other potent immunosuppressant or immunomodulatory drugs or treatments
  11. Current enrollment in a pharmacologic interventional trial of host response modifiers
  12. Concomitant COVID-19 antiviral therapy is allowed
  13. History of hypersensitivity or idiosyncratic reaction to IC14

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): NCT04391309


Contacts
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Contact: Mark Wurfel, MD, PhD 206 897-5387 mwurfel@uw.edu

Locations
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United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Contact: Mark Wurfel, MD, PhD    206-897-5387    mwurfel@uw.edu   
Sponsors and Collaborators
Implicit Bioscience
University of Washington
Investigators
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Principal Investigator: Mark Wurfel, MD, PhD University of Washington
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Responsible Party: Implicit Bioscience
ClinicalTrials.gov Identifier: NCT04391309    
Other Study ID Numbers: COV04
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 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 Implicit Bioscience:
COVID-19
Additional relevant MeSH terms:
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Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs