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