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

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 2L oxygen by nasal cannula to maintain SpO2 ≥93%, or PaO2/FiO2 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 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.

Exclusion Criteria

• Expected survival or time to withdrawal of life-sustaining treatments expected to be 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.