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.
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
Drug: Placebo
Matching placebo is an injectable emulsion containing no active pharmaceutical ingredient. Placebo will be administered intravenously as a continuous infusion
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.
Northwestern Memorial Hospital
Chicago, Illinois, United States