A Placebo-Controlled Study of Auxora for the Extended Treatment of High- Risk Patients With Critical COVID-19 Pneumonia (CARDEA-Plus)

This is an interventional treatment trial for Pneumonia focused on measuring COVID-19, Coronavirus, Pneumonia, Calcium release-activated calcium channel (CRAC) inhibitors, CM4620, Auxora Read More

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, as documented by either of the following:

   • PCR positive in sample collected < 72 hours prior to consent;
   • PCR positive in sample collected ≥ 72 hours prior to consent, 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;

2. At least 1 of the following symptoms:

   o Fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress;

3. A PaO2/FiO2 ≤200 recorded in the 24 hours before consent. The PaO2/FiO2 can be imputed from pulse oximetry;
4. Oxygen therapy being administered via HFNC or NIV
5. The presence of a respiratory infiltrate or abnormality consistent with pneumonia that is documented by either a CXR or CT scan of the lungs;
6. The patient is ≥18 years of age;
7. A female patient of childbearing potential must not attempt to become pregnant for 180 days, and if sexually active with a male partner, is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug;
8. A male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug. A male patient must not donate sperm for 180 days;
9. 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. Do Not Intubate order;
2. PaO2/FiO2 ≤75 recorded at the time of consent. The PaO2/FiO2 can be imputed from pulse oximetry;
3. Receiving IMV via endotracheal intubation or tracheostomy;
4. Receiving ECMO;
5. Shock defined by the use of vasopressors;

6. Known history of:

   • Organ or hematologic transplant;
   • HIV;
   • Active hepatitis B, or hepatitis C infection;

7. Current treatment with:

   • Chemotherapy;
   • Immunosuppressive medications or immunotherapy (see protocol (Section 5.3) for list of prohibited immunosuppressive medications and immunotherapy) at the time of consent;
   • Hemodialysis or Peritoneal Dialysis;
8. Known to be pregnant or is nursing;
9. Currently participating in another study of an investigational drug or therapeutic medical device at the time of consent;
10. Known allergy to eggs or any of the excipients in study drug.