Status:
COMPLETED
A Study of Auxora in Patients With Severe COVID-19 Pneumonia
Lead Sponsor:
CalciMedica, Inc.
Conditions:
Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Part 1 of this trial enrolled 30 patients to receive Auxora (formerly CM4620) in a 2:1 randomized, open label trial of patients with severe and critical COVID-19 pneumonia. Part 2 of this study random...
Eligibility Criteria
Inclusion
- Part 1:
- Inclusion Criteria
- 1\. The diagnosis of COVID-19 established standard RT-PCR assay;
- At least 1 of the following symptoms:
- Fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress;
- At least 1 of the following clinical signs:
- Respiratory rate ≥30, heart rate ≥125, SpO2 \<93% on room air or requires \>2L oxygen by nasal cannula to maintain SpO2 ≥93%, or PaO2/FiO2 \<300, estimated from pulse oximetry or determined by arterial blood gas;
- The presence of a respiratory infiltrate or abnormality consistent with pneumonia that is documented by either a CXR or CT scan of the lungs;
- The patient is ≥18 years of age;
- 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 CM4620-IE;
- 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 CM4620-IE. 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.
- Do Not Intubate order;
- Home mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing;
- PaO2/FiO2 ≤75 at the time of Screening. The PaO2/FiO2 may be estimated from pulse oximetry (Appendix 1) or determined by arterial blood gas;
- Noninvasive positive pressure ventilation;
- Invasive mechanical ventilation via endotracheal intubation or tracheostomy;
- ECMO;
- Shock defined by the use of vasopressors;
- Multiple organ dysfunction or failure;
- Positive Influenza A or B testing if tested as local standard of care;
- The patient has a history any of the following: Organ or hematologic transplant;HIV; Active hepatitis B, or hepatitis C infection;
- Current treatment with:Chemotherapy; Immunosuppressive medications or immunotherapy at the time of consent; Hemodialysis or Peritoneal Dialysis
- Have a history of venous thromboembolism (VTE) (deep vein thrombosis \[DVT\] or pulmonary embolism \[PE\]) within 12 weeks prior to screening or have a history of recurrent (\> 1) VTE;
- 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.
- Part 2:
- 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, as documented by either of the following:
- PCR positive in sample collected \< 72 hours prior to randomization;
- PCR positive in sample collected ≥ 72 hours prior to randomization, with inability to obtain a repeat sample (e.g. due to lack of testing supplies, or limited testing capacity, or results taking \>24 hours, etc.) or progressive disease suggestive of ongoing SARS-CoV-2 infection;
- At least 1 of the following symptoms: Fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress;
- At least 1 of the following signs at Screening or noted in the 24 hours before Screening:
- PaO2/FiO2 ≤200 when receiving supplemental oxygen. The PaO2/FiO2 may be estimated from pulse oximetry (Appendix 1) or determined by arterial blood gas;
- If SpO2 ≥97%, must be receiving 10L or more of supplemental oxygen;
- The presence of a respiratory infiltrate or abnormality consistent with pneumonia that is documented by either a chest X-ray or computerized tomography scan of the lungs;
- The patient is ≥ 18 years of age;
- 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 CM4620-IE;
- 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 CM4620-IE. 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.
Key Trial Info
Start Date :
April 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2021
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT04345614
Start Date
April 8 2020
End Date
July 30 2021
Last Update
September 18 2025
Active Locations (17)
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1
Long Beach Memorial
Long Beach, California, United States, 90806
2
University of Southern California / LA County
Los Angeles, California, United States, 90033
3
Sharp Memorial San Diego
San Diego, California, United States, 92123
4
National Jewish Health / St. Joseph's Hospital
Denver, Colorado, United States, 80220