Experimental drug auxora shows promise in severe COVID-19 pneumonia trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Part 1: Inclusion Criteria 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. Exclusion Criteria: 1. Expected survival or time to withdrawal of life-sustaining treatments expected to be \<7 days. 2. Do Not Intubate order; 3. 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; 4. 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; 5. Noninvasive positive pressure ventilation; 6. Invasive mechanical ventilation via endotracheal intubation or tracheostomy; 7. ECMO; 8. Shock defined by the use of vasopressors; 9. Multiple organ dysfunction or failure; 10. Positive Influenza A or B testing if tested as local standard of care; 11. The patient has a history any of the following: Organ or hematologic transplant;HIV; Active hepatitis B, or hepatitis C infection; 12. Current treatment with:Chemotherapy; Immunosuppressive medications or immunotherapy at the time of consent; Hemodialysis or Peritoneal Dialysis 13. 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; 14. The patient is known to be pregnant or is nursing; 15. Currently participating in another study of an investigational drug or therapeutic medical device at the time of consent; 16. Allergy to eggs or any of the excipients in study drug. Part 2: 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 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. Exclusion Criteria: 1. Expected survival or time to withdrawal of life-sustaining treatments expected to be \<7 days. 2. Do Not Intubate order; 3. 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; 4. 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; 5. Noninvasive positive pressure ventilation; 6. Invasive mechanical ventilation via endotracheal intubation or tracheostomy; 7. Extracorporeal membrane oxygenation (ECMO); 8. Shock defined by the use of vasopressors; 9. Multiple organ dysfunction or failure; 10. Positive Influenza A or B testing if tested as local standard of care; 11. The patient has a history of any of the following: Organ or hematologic transplant; HIV; Active hepatitis B, or hepatitis C infection; 12. Current treatment with:Chemotherapy;Immunosuppressive medications or immunotherapy at the time of consent; c. Hemodialysis or Peritoneal Dialysis; 13. 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; 14. The patient is known to be pregnant or is nursing; 15. Currently participating in another study of an investigational drug or therapeutic medical device at the time of consent; 16. Allergy to eggs or any of the excipients in study drug.