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

Inclusion Criteria

• •Part 1:
• •1. 1\. The diagnosis of COVID-19 established standard RT-PCR assay;
• •2. 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;
• •3. 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;
• •4. The presence of a respiratory infiltrate or abnormality consistent with pneumonia that is documented by either a CXR or CT scan of the lungs;
• •5. The patient is ≥18 years of age;
• •6. 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;
• •7. 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;
• •8. 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.
• •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 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;
• •2. 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;
• •3. 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;
• •4. 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;
• •5. The patient is ≥ 18 years of age;
• •6. 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;
• •7. 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;
• •8. 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.