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 <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 criteria

• 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.

Exclusion criteria

• 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;
• Extracorporeal membrane oxygenation (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 of 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; c. 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.