Pemziviptadil (PB1046), a Long-acting, Sustained Release Human VIP Analogue, Intended to Provide … (NCT04433546) | Clinical Trial Compass
TerminatedPhase 2
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).
Stopped: Company no longer pursing indication
United States54 participantsStarted 2020-07-15
Plain-language summary
This is a multicenter, randomized, double-blind, parallel group study to investigate the efficacy of pemziviptadil (PB1046) by improving the clinical outcomes in hospitalized COVID-19 patients at high risk for rapid clinical deterioration, acute respiratory distress syndrome (ARDS) and death.
The study will enroll approximately 210 hospitalized COVID-19 patients who require urgent decision-making and treatment at approximately 20 centers in the United States.
Who can participate
Age range18 Years – 85 Years
SexALL
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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
✕. 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
What they're measuring
1
Time to clinical recovery from initiation of pemziviptadil (PB1046)
✕. 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: