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Trial record 1 of 4 for:    auxora
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A Study of Auxora in Patients With Critical COVID-19 Pneumonia

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04661540
Recruitment Status : Active, not recruiting
First Posted : December 10, 2020
Last Update Posted : May 12, 2022
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
CalciMedica, Inc.

Brief Summary:
This is a single-blind study consisting of up to 3 cohorts Patients will be randomized 3:1 to Auxora or Placebo. The first 4 patients will be enrolled in Cohort 1. If dose escalation occurs, the next 4 patients will be enrolled in Cohort 2 If dose escalation occurs, the next 8 patients will be enrolled in Cohort 3. The decision to escalate dosing will be made by CalciMedica in consultation with the PI and after the review of safety events in Cohorts 1 and 2.

Condition or disease Intervention/treatment Phase
Pneumonia Drug: CM4620-IE (Injectable Emulsion) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Single-Blind Dose-Ranging Pharmacodynamic Study of Auxora for the Treatment of Patients With Critical COVID-19 Pneumonia
Actual Study Start Date : March 2, 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


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

Drug: CM4620-IE (Injectable Emulsion)
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 Name: Auxora

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

Drug: Placebo
Matching placebo is an injectable emulsion containing no active pharmaceutical ingredient. Placebo will be administered intravenously as a continuous infusion




Primary Outcome Measures :
  1. Proportion of immune cells in BAL fluid and T cell activation will be assessed [ Time Frame: Baseline Assessment up to 120 hours ]
  2. Impact of Auxora on the emergence of new clusters/cell types/cell states [ Time Frame: Baseline Assessment up to 120 hours ]
  3. 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 ]

Secondary Outcome Measures :
  1. 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

  2. Number of Days on Mechanical Ventilation after randomization [ Time Frame: From randomization until patient is extubated assessed up to 60 days ]
  3. Number of Days in the Hospital after randomization [ Time Frame: From randomization until discharge from the hospital assessed up to 60 days ]
  4. Number of Days in the Intensive Care Unit (ICU) after randomization [ Time Frame: From randomization until discharge from ICU assessed up to 60 days ]
  5. 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

  6. Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: From randomization up to 60 days ]
  7. Intensity and relationship of TEAEs and SAEs [ Time Frame: From randomization up to 60 days ]
  8. Mortality [ Time Frame: Randomization up to 60 days ]


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. Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen;
  2. 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;
  3. The patient is ≥18 years of age at the time of consent;
  4. QTcF interval ≤ 440 milliseconds;
  5. 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;
  6. 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;
  7. 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:

  1. Expected survival or time to withdrawal of life-sustaining treatments expected to be <7 days.
  2. ECMO;
  3. Suspected septic shock;
  4. The patient has a history of:

    • Organ or hematologic transplant;
    • HIV;
    • Active hepatitis B or hepatitis C infection;
  5. 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;
  6. The patient is known to be pregnant or is nursing;
  7. Currently participating in another study of an investigational drug or therapeutic medical device at the time of consent;
  8. Allergy to eggs or any of the excipients in study drug.

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): NCT04661540


Locations
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United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
CalciMedica, Inc.
Northwestern University
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Responsible Party: CalciMedica, Inc.
ClinicalTrials.gov Identifier: NCT04661540    
Other Study ID Numbers: CM4620-205
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: May 12, 2022
Last Verified: May 2022

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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 CalciMedica, Inc.:
COVID-19
Coronavirus
Pneumonia
Calcium Release-Activated Calcium Channel (CRAC) Inhibitors
CM4620
Auxora
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Respiratory Tract Infections
Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases