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A Study of Auxora in Patients With Critical COVID-19 Pneumonia

Primary Purpose

Pneumonia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

CM4620-IE (Injectable Emulsion)

Placebo

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring COVID-19, Coronavirus, Pneumonia, Calcium Release-Activated Calcium Channel (CRAC) Inhibitors, CM4620, Auxora

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Northwestern Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Auxora

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Proportion of immune cells in BAL fluid and T cell activation will be assessed

Impact of Auxora on the emergence of new clusters/cell types/cell states

Impact of Auxora on detection of SARS-CoV-2 positive and negative strand RNA in infected cells

Secondary Outcome Measures

Plasma Levels of CM4620

Concentration of Auxora from blood samples and fluid collected from BAL

Number of Days on Mechanical Ventilation after randomization

Number of Days in the Hospital after randomization

Number of Days in the Intensive Care Unit (ICU) after randomization

Pre-defined changes in cardiac conduction assessed by ECG

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

Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Intensity and relationship of TEAEs and SAEs

Mortality

Full Information

NCT ID

NCT04661540

First Posted

December 4, 2020

Last Updated

August 17, 2022

Sponsor

CalciMedica, Inc.

Collaborators

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT04661540

Brief Title

A Study of Auxora in Patients With Critical COVID-19 Pneumonia

Official Title

A Single-Blind Dose-Ranging Pharmacodynamic Study of Auxora for the Treatment of Patients With Critical COVID-19 Pneumonia

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

March 2, 2021 (Actual)

Primary Completion Date

May 9, 2021 (Actual)

Study Completion Date

November 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CalciMedica, Inc.

Collaborators

Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonia

Keywords

COVID-19, Coronavirus, Pneumonia, Calcium Release-Activated Calcium Channel (CRAC) Inhibitors, CM4620, Auxora

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Sequential Assignment

Masking

Participant

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Auxora

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

CM4620-IE (Injectable Emulsion)

Other Intervention Name(s)

Auxora

Intervention Description

Auxora is an injectable emulsion containing 1.6mg/ML of the active pharmaceutical ingredient CM4620. Auxora will be administered intravenously as a continuous infusion

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of immune cells in BAL fluid and T cell activation will be assessed

Time Frame

Baseline Assessment up to 120 hours

Title

Impact of Auxora on the emergence of new clusters/cell types/cell states

Time Frame

Baseline Assessment up to 120 hours

Title

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 Measure Information:

Title

Plasma Levels of CM4620

Description

Concentration of Auxora from blood samples and fluid collected from BAL

Time Frame

From end of first infusion of study drug up to 144 hours

Title

Number of Days on Mechanical Ventilation after randomization

Time Frame

From randomization until patient is extubated assessed up to 60 days

Title

Number of Days in the Hospital after randomization

Time Frame

From randomization until discharge from the hospital assessed up to 60 days

Title

Number of Days in the Intensive Care Unit (ICU) after randomization

Time Frame

From randomization until discharge from ICU assessed up to 60 days

Title

Pre-defined changes in cardiac conduction assessed by ECG

Description

Time Frame

From screening up to 144 hours

Title

Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time Frame

From randomization up to 60 days

Title

Intensity and relationship of TEAEs and SAEs

Time Frame

From randomization up to 60 days

Title

Mortality

Time Frame

Randomization up to 60 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Northwestern Memorial Hospital

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

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A Study of Auxora in Patients With Critical COVID-19 Pneumonia

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