Status:
TERMINATED
A Study of Auxora in Patients With Critical COVID-19 Pneumonia
Lead Sponsor:
CalciMedica, Inc.
Collaborating Sponsors:
Northwestern University
Conditions:
Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Detailed Description
The primary objective of this study was to assess the pharmacodynamic response of bronchoalveolar lavage (BAL) T cell/monocyte subsets and chemokine release to various doses of Auxora in patients with...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04661540
Start Date
March 2 2021
End Date
December 21 2021
Last Update
November 21 2025
Active Locations (1)
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1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611