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

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04661540
• Other study ID #: CM4620-205
• Status: Completed
• Phase: Phase 2
• Start date: March 2, 2021
• Est. completion date: November 2, 2021

Study information

• Verified date: May 2022
• Source: CalciMedica, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 2, 2021
• Est. primary completion date: May 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Pneumonia

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
CalciMedica, Inc.	Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of immune cells in BAL fluid and T cell activation will be assessed		Baseline Assessment up to 120 hours
Primary	Impact of Auxora on the emergence of new clusters/cell types/cell states		Baseline Assessment up to 120 hours
Primary	Impact of Auxora on detection of SARS-CoV-2 positive and negative strand RNA in infected cells		Baseline Assessment up to 60 days
Secondary	Plasma Levels of CM4620	Concentration of Auxora from blood samples and fluid collected from BAL	From end of first infusion of study drug up to 144 hours
Secondary	Number of Days on Mechanical Ventilation after randomization		From randomization until patient is extubated assessed up to 60 days
Secondary	Number of Days in the Hospital after randomization		From randomization until discharge from the hospital assessed up to 60 days
Secondary	Number of Days in the Intensive Care Unit (ICU) after randomization		From randomization until discharge from ICU assessed up to 60 days
Secondary	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	From screening up to 144 hours
Secondary	Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)		From randomization up to 60 days
Secondary	Intensity and relationship of TEAEs and SAEs		From randomization up to 60 days
Secondary	Mortality		Randomization up to 60 days