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

NCT04661540 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: CM4620-205
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-blind study of Auxora in patients with critical COVID-19 pneumonia, consisting of up to 3 cohorts of escalating dose. The main goal was to assess pharmacodynamic parameters of immune response, while also assessing safety and tolerability of the drug in this patient population.

Conditions

Pneumonia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Combined CD4, CD8, and Monocyte Cell Population in BAL Fluid, as a Percent of Total WBC Population.

  Pharmacodynamic endpoint: Assessment of pharmacodynamic response of bronchoalveolar lavage (BAL) T cell/monocyte subsets to Auxora treatment. Flow cytometry was performed on fluid collected from the BAL performed prior to the SFISD (-12 hours) and 24 (±12) hours after completing the last infusion of study drug in Cohorts 1 and 2 and during the final 24 hours of the continuous infusion in Cohort 3. The percentage of total WBC population was assessed for the combined CD4, CD8, and monocyte cell population, and the change between Pre- and Post-Infusion samples (Post value minus Pre value) was reported.

  Baseline Assessment up to 120 hours

Secondary Outcomes (5)

• Change From Baseline in Percent of Immune Cells in BAL Fluid

  Baseline Assessment up to 120 hours

• Number of Patients Alive at Day 60

  Randomization through Day 60

• Number of Days Alive and Out of the Intensive Care Unit (ICU)

  From randomization until discharge from ICU, assessed up to 60 days

• Number of Days Alive and Out of the Hospital

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

• Number of Days Alive and Off Mechanical Ventilation

  From randomization until patient is extubated, assessed up to 60 days

Other Outcomes (4)

• Number of Patients Experiencing an AE Considered Possibly Related to Study Drug

  Randomization through Day 30

• Number of Patients Experiencing an SAE (at Least 1)

  Randomization through day 30

• Intensity of AEs

  Randomization through Day 30

Study Arms (2)

Auxora

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR

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

Interventions

CM4620-IE (Injectable Emulsion) DRUG

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

Also known as: Auxora

Auxora

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CalciMedica, Inc.: lead
• Northwestern University: collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Pneumonia; COVID-19; Coronavirus Infections

Interventions

zegocractin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Limitations and Caveats

This trial was terminated early due to the limited number of new COVID-19 hospitalizations, leading to small numbers of subjects analyzed (7 randomized to Auxora and 2 randomized to placebo). Hence, no formal hypothesis testing was performed. All performed analyses were based on descriptive summaries.

Results Point of Contact

• Title: Sudarshan Hebbar, MD (Chief Medical Officer)
• Organization: CalciMedica

sudarshan@calcimedica.com

(816) 838-7105

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 10, 2020
• Study Start: March 2, 2021
• Primary Completion: December 21, 2021
• Study Completion: December 21, 2021
• Last Updated: March 18, 2026
• Results First Posted: November 21, 2025

Record last verified: 2026-03

Locations

US (1)