Pemziviptadil (PB1046), a Long-acting, Sustained Release Human VIP Analogue, Intended to Provide Clinical Improvement to Hospitalized COVID-19 Patients at High Risk for Rapid Clinical Deterioration and Acute Respiratory Distress Syndrome (ARDS).

Exclusion Criteria

• •Subjects will be excluded from the study if they meet any of the following criteria:
• •1. Patients considered unsalvageable or expected to expire within 24 hours
• •2. On mechanical ventilation or imminent need for mechanical ventilation expected in the next 24 hours
• •3. Evidence of acute end-organ injury in 2 or more organ systems (not including cardiac or pulmonary), such as, renal, hepatic, or CNS injury
• •4. Receiving another investigational therapy for treatment or prevention of COVID-19-related hypoxemic respiratory failure or ARDS other than antiviral therapy
• •5. Systolic blood pressure (SBP) \< 95 mmHg and/or diastolic blood pressure (DBP) \< 50 mmHg or overt symptomatic hypotension during screening
• •6. Resting heart rate \> 110 BPM (beats per minute) during screening
• •7. Severe chronic renal failure as measured by the estimated glomerular filtration rate (eGFR) of \< 30 mL/min/1.73m2 using the local laboratory calculation of eGFR.
• •8. Significant liver dysfunction as measured by any one of the following at screening:
• •* ALT (Alanine transaminase) \> 3.0 times ULN (upper limit of normal)
• •* AST (Aspartate transaminase) \> 3.0 times ULN
• •* Serum bilirubin ≥ 1.6 mg/dL
• •9. Any in-patient surgical procedure or hospitalization (defined as \> 23 hours) within 30 days of subject screening except for prior hospitalization for COVID-19
• •10. Known hypersensitivity to study drug or any of the excipients of the drug formulation
• •11. Pregnant or lactating female subjects
• •12. Any other condition which, in the opinion of the Investigator, would place the subject at increased risk or would preclude obtaining informed consent or confound the objectives of study