- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04661540
A Study of Auxora in Patients With Critical COVID-19 Pneumonia
A Single-Blind Dose-Ranging Pharmacodynamic Study of Auxora for the Treatment of Patients With Critical COVID-19 Pneumonia
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen;
Moderate ARDS characterized by the following criteria:
- Invasive mechanical ventilation with a minimum PEEP of 5 cm H2O;
- PaO2/FiO2 ≤200 that may be estimated from pulse oximetry or determined by arterial blood gas;
- No evidence of volume overload or heart failure;
- The patient is ≥18 years of age at the time of consent;
- QTcF interval ≤ 440 milliseconds;
- A female patient of childbearing potential must not attempt to become pregnant for 39 months, and if sexually active with a male partner, is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug;
- A male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug. A male patient must not donate sperm for 39 months;
- The patient is willing and able to, or has a legal authorized representative (LAR) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.
Exclusion Criteria:
- Expected survival or time to withdrawal of life-sustaining treatments expected to be <7 days.
- ECMO;
- Suspected septic shock;
The patient has a history of:
- Organ or hematologic transplant;
- HIV;
- Active hepatitis B or hepatitis C infection;
Current treatment with:
- Chemotherapy;
- Immunosuppressive medications or immunotherapy (see Section 5.3 for list of prohibited immunosuppressive medications and immunotherapy) at the time of consent;
- Hemodialysis or Peritoneal Dialysis;
- The patient is known to be pregnant or is nursing;
- Currently participating in another study of an investigational drug or therapeutic medical device at the time of consent;
- Allergy to eggs or any of the excipients in study drug.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Auxora
Auxora will be given as a continuous infusion: Day 1: All 3 cohorts will receive 1.25 mL/kg over 4 hours; After initial infusion is complete, Cohort 3 will receive a continuous infusion of 1.0 mL/kg/24 hours for 96 hours Day 2: Cohort 1 will receive 1.0 mL/kg over 4 hours; Cohort 2 will receive 1.25mL/kg over 4 hours Day 3: Cohort 1 and 2 will receive 1.0 mL/kg over 4 hours Day 4: Cohort 2 will receive 1.0 mL/kg over 4 hours |
Auxora is an injectable emulsion containing 1.6mg/ML of the active pharmaceutical ingredient CM4620.
Auxora will be administered intravenously as a continuous infusion
Other Names:
|
Placebo Comparator: Placebo
Placebo will be given as a continuous infusion: Day 1: All 3 cohorts will receive 1.25 mL/kg over 4 hours. After initial infusion is complete, Cohort 3 will receive a continuous infusion of 1.0 mL/kg/24 hours for 96 hours Day 2: Cohort 1 will receive 1.0 mL/kg over 4 hours; Cohort 2 will receive 1.25mL/kg over 4 hours Day 3: Cohort 1 and 2 will receive 1.0 mL/kg over 4 hours Day 4: Cohort 2 will receive 1.0 mL/kg over 4 hours |
Matching placebo is an injectable emulsion containing no active pharmaceutical ingredient.
Placebo will be administered intravenously as a continuous infusion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of immune cells in BAL fluid and T cell activation will be assessed
Time Frame: Baseline Assessment up to 120 hours
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Baseline Assessment up to 120 hours
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Impact of Auxora on the emergence of new clusters/cell types/cell states
Time Frame: Baseline Assessment up to 120 hours
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Baseline Assessment up to 120 hours
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Impact of Auxora on detection of SARS-CoV-2 positive and negative strand RNA in infected cells
Time Frame: Baseline Assessment up to 60 days
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Baseline Assessment up to 60 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma Levels of CM4620
Time Frame: From end of first infusion of study drug up to 144 hours
|
Concentration of Auxora from blood samples and fluid collected from BAL
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From end of first infusion of study drug up to 144 hours
|
Number of Days on Mechanical Ventilation after randomization
Time Frame: From randomization until patient is extubated assessed up to 60 days
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From randomization until patient is extubated assessed up to 60 days
|
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Number of Days in the Hospital after randomization
Time Frame: From randomization until discharge from the hospital assessed up to 60 days
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From randomization until discharge from the hospital assessed up to 60 days
|
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Number of Days in the Intensive Care Unit (ICU) after randomization
Time Frame: From randomization until discharge from ICU assessed up to 60 days
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From randomization until discharge from ICU assessed up to 60 days
|
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Pre-defined changes in cardiac conduction assessed by ECG
Time Frame: From screening up to 144 hours
|
Changes in cardiac conduction are defined as: QTcF interval of ≥ 500 msec; QTcF prolongation of ≥ 60 msec as compared to baseline; Mobitz Type II second degree atrioventricular (AV) block; Third degree or high grade AV block; or Polymorphic Ventricular Tachycardia
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From screening up to 144 hours
|
Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: From randomization up to 60 days
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From randomization up to 60 days
|
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Intensity and relationship of TEAEs and SAEs
Time Frame: From randomization up to 60 days
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From randomization up to 60 days
|
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Mortality
Time Frame: Randomization up to 60 days
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Randomization up to 60 days
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CM4620-205
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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