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

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CalciMedica, Inc.
• Collaborator: Northwestern University

Criteria

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.