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). (VANGARD)
Acute Respiratory Distress Syndrome, Coronavirus, Hypoxic Respiratory Failure
About this trial
This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring Acute Respiratory Distress Syndrome (ARDS), Respiratory distress/failure, COVID
Eligibility Criteria
Inclusion Criteria:
- Written or witnessed verbal informed consent from patient or remote legal authorized representative (LAR) or remote family member as permitted by governing local or central Institutional Review Board (IRB)/independent Ethic Committee (IEC).
- Male or female 18-85 years old hospitalized COVID-19 patients (positive local SARS-CoV2 test)
- Receiving oxygen (O2) by face mask or nasal cannula/prongs and/or with elevated markers of cardiac injury or dysfunction (hsTnI or NT-proBNP) as assessed by local testing
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the following criteria:
- Patients considered unsalvageable or expected to expire within 24 hours
- On mechanical ventilation or imminent need for mechanical ventilation expected in the next 24 hours
- Evidence of acute end-organ injury in 2 or more organ systems (not including cardiac or pulmonary), such as, renal, hepatic, or CNS injury
- Receiving another investigational therapy for treatment or prevention of COVID-19-related hypoxemic respiratory failure or ARDS other than antiviral therapy
- Systolic blood pressure (SBP) < 95 mmHg and/or diastolic blood pressure (DBP) < 50 mmHg or overt symptomatic hypotension during screening
- Resting heart rate > 110 BPM (beats per minute) during screening
- 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.
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
- Any in-patient surgical procedure or hospitalization (defined as > 23 hours) within 30 days of subject screening except for prior hospitalization for COVID-19
- Known hypersensitivity to study drug or any of the excipients of the drug formulation
- Pregnant or lactating female subjects
- 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
Sites / Locations
- Baptist Health Research Institute
- Sarasota Memorial Hospital
- The University of Kansas Medical Center
- Adventist Healthcare White Oak Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
High Dose (100 mg) Group
Middle Dose (40 mg) Group
Low Dose (10 mg) Control Group
High: Pemziviptadil (PB1046) 100 mg subcutaneous (SC) weekly for 4 weeks or until hospital discharge
Middle: Pemziviptadil (PB1046) 40 mg SC weekly for 4 weeks or until hospital discharge
Low Control: Pemziviptadil (PB1046) 10 mg SC weekly for 4 weeks or until hospital discharge