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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Pneumonia

In brief

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.

Key facts

Study ID

NCT04661540

Run by

CalciMedica, Inc.

People needed

10

Starts

2021-03-02

Expected to finish

2021-12-21

Last updated by the study team

2026-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Northwestern Memorial Hospital — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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