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).
NCT ID: NCT04433546
Last Updated: 2020-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
54 participants
INTERVENTIONAL
2020-07-15
2020-12-02
Brief Summary
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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.
Detailed Description
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All subjects will be randomized to either a low control (10 mg), middle (40 mg), or high (100 mg) dose of active treatment. If subject is not discharged, they will continue to Day 7, 14, 21 treatments. Pemziviptadil (PB1046) is expected to improve the clinical outcomes of hospitalized COVID-19 subjects with an earlier hospital discharge and improvement in survival.
The duration of hospitalization for each subject will be determined by clinical status independent of study procedures. The estimated duration of the study for each subject, including screening, is approximately 35+7 days. The subjects may be involved up to 42 days.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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High Dose (100 mg) Group
High: Pemziviptadil (PB1046) 100 mg subcutaneous (SC) weekly for 4 weeks or until hospital discharge
Pemziviptadil (PB1046)
Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection
Middle Dose (40 mg) Group
Middle: Pemziviptadil (PB1046) 40 mg SC weekly for 4 weeks or until hospital discharge
Pemziviptadil (PB1046)
Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection
Low Dose (10 mg) Control Group
Low Control: Pemziviptadil (PB1046) 10 mg SC weekly for 4 weeks or until hospital discharge
Low Dose (10 mg) Control
Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection (10 mg diluted in sodium chloride to match active drug volume)
Interventions
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Pemziviptadil (PB1046)
Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection
Low Dose (10 mg) Control
Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection (10 mg diluted in sodium chloride to match active drug volume)
Eligibility Criteria
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Inclusion Criteria
2. Male or female 18-85 years old hospitalized COVID-19 patients (positive local SARS-CoV2 test)
3. 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
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
18 Years
85 Years
ALL
No
Sponsors
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PhaseBio Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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Baptist Health Research Institute
Jacksonville, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
Adventist Healthcare White Oak Medical Center
Silver Spring, Maryland, United States
Countries
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Other Identifiers
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PB1046-PT-CL-0007
Identifier Type: -
Identifier Source: org_study_id