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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)

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ClinicalTrials.gov Identifier: NCT04433546
Recruitment Status : Not yet recruiting
First Posted : June 16, 2020
Last Update Posted : June 19, 2020
Sponsor:
Information provided by (Responsible Party):
PhaseBio Pharmaceuticals Inc.

Brief Summary:

This is a multicenter, randomized, double-blind, parallel group study to investigate the efficacy of PB1046 by improving the clinical outcomes and increasing days alive and free of respiratory failure 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.


Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Coronavirus Hypoxic Respiratory Failure Hypoxemic Respiratory Failure Respiratory Complication Respiratory Insufficiency Cardiac Dysfunction Pneumonia Pulmonary Edema Pulmonary Inflammation Respiratory Failure Cytokine Storm COVID 19 SARS-CoV-2 Cardiac Event Cardiac Complication Cardiac Failure Cardiac Infarct Drug: PB1046 Drug: Low Dose (10 mg) Control Phase 2

Detailed Description:

The study will consist of a Screening/Pre-treatment period, on-site randomization to study treatment. On Day 0 (Visit 2) subjects who meet inclusion criteria and none of exclusion criteria will receive a weekly subcutaneous injection that will continue once weekly until hospital discharge or for a maximum of 4 weeks during hospitalization.

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. PB1046 is expected to improve the clinical outcomes of hospitalized COVID-19 subjects with longer survival free from respiratory failure at 28 day.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel Group Study to Assess the Efficacy and Safety of Once Weekly Subcutaneous Injections of PB1046, a Sustained-Release VIP (Vasoactive Intestinal Peptide) ANalogue, in Hospitalized COVID-19 Patients at HiGh Risk for Rapid Clinical Deterioration and ARDS (PB1046 VANGARD Study)
Estimated Study Start Date : June 26, 2020
Estimated Primary Completion Date : December 18, 2020
Estimated Study Completion Date : December 18, 2020


Arm Intervention/treatment
Experimental: High Dose (100 mg) Group
High: PB1046 100 mg subcutaneous (SC) weekly for 4 weeks or until hospital discharge
Drug: PB1046
PB1046, Once Weekly Subcutaneous Injection

Experimental: Middle Dose (40 mg) Group
Middle: PB1046 40 mg SC weekly for 4 weeks or until hospital discharge
Drug: PB1046
PB1046, Once Weekly Subcutaneous Injection

Placebo Comparator: Low Dose (10 mg) Control Group
Low Control: PB1046 10 mg SC weekly for 4 weeks or until hospital discharge
Drug: Low Dose (10 mg) Control
PB1046, Once Weekly Subcutaneous Injection (10 mg diluted in sodium chloride to match active drug volume)




Primary Outcome Measures :
  1. Days alive and free of respiratory failure from initiation of PB1046 [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Time to clinical recovery (being well enough for hospital discharge or returning to normal baseline activity level prior to discharge) [ Time Frame: 28 days ]
  2. Development of ARDS (PaO2:FiO2 ratio < 300 mm Hg) during hospitalization [ Time Frame: Any time point between injection initiation and Day 28 ]
    PaO2:FiO2 ratio is the ratio of partial pressure of arterial oxygen to percentage of inspired oxygen

  3. All-cause mortality [ Time Frame: 28 days ]
  4. Reduction in hospital resource utilization defined as a composite of:total days: in hospital, in ICU, on ventilator, on ECMO, with invasive hemodynamic monitoring, with mechanical circulatory support, and with inotropic or vasopressor therapy [ Time Frame: 28 days ]
    Composite of: Total hospital days, Total ICU days, Total days of ventilator use, Total days of ECMO, Total days of invasive hemodynamic monitoring, Total days of mechanical circulatory support, Total days of inotropic or vasopressor therapy

  5. Time to clinical improvement as defined by reduction of at least 2 points on an 8-category ordinal scale of clinical improvement or discharge from hospital, whichever comes first. [ Time Frame: Any time point between injection initiation and Day 28 ]
  6. Change from baseline in cardiac marker high sensitivity troponin I (hsTnI) [ Time Frame: Any time point between injection initiation and Day 35+7 ]
  7. Change from baseline in cardiac marker NT-proBNP [ Time Frame: Any time point between injection initiation and Day 35+7 ]
  8. Change from baseline in TNF alpha [ Time Frame: Any time point between injection initiation and Day 35+7 ]
  9. Change from baseline in IL-1 [ Time Frame: Any time point between injection initiation and Day 35+7 ]
  10. Change from baseline in IL-6 [ Time Frame: Any time point between injection initiation and Day 35+7 ]
  11. Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by clinical adverse events (AEs) and their relationship to PB1046 [ Time Frame: Any time point between injection initiation and Day 35+7 ]
  12. Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by vital signs and their relationship to PB1046 [ Time Frame: Any time point between injection initiation and Day 35+7 ]
  13. Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by laboratory results and their relationship to PB1046 [ Time Frame: Any time point between injection initiation and Day 35+7 ]
  14. Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by electrocardiogram (ECG) abnormalities and their relationship to PB1046 [ Time Frame: Any time point between injection initiation and Day 35+7 ]
  15. Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by incidence of anti-drug antibodies and their relationship to PB1046 [ Time Frame: Any time point between injection initiation and Day 35+7 ]

Other Outcome Measures:
  1. Impact on invasive hemodynamic parameters as measured by pulmonary artery pressure if patients require right-heart catherization [ Time Frame: Any time point between injection initiation and Day 35+7 ]
  2. Impact on invasive hemodynamic parameters as measured by cardiac output if patients require right-heart catherization [ Time Frame: Any time point between injection initiation and Day 35+7 ]
  3. Incidence of multi-system organ failure (MSOF) [ Time Frame: Any time point between injection initiation and Day 35+7 ]
  4. Number of multi-system organ failure (MSOF) free days [ Time Frame: Any time point between injection initiation and Day 35+7 ]
  5. Number of subjects requiring extracorporeal membrane oxygenation (ECMO) [ Time Frame: Any time point between injection initiation and Day 35+7 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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).
  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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04433546


Contacts
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Contact: Clinical Trials 888-521-2805 Clinicaltrials@phasebio.com

Sponsors and Collaborators
PhaseBio Pharmaceuticals Inc.
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Responsible Party: PhaseBio Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT04433546    
Other Study ID Numbers: PB1046-PT-CL-0007
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PhaseBio Pharmaceuticals Inc.:
Acute Respiratory Distress Syndrome (ARDS)
Respiratory distress/failure
COVID
Additional relevant MeSH terms:
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Pneumonia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Acute Lung Injury
Pulmonary Edema
Pulmonary Valve Insufficiency
Heart Failure
Syndrome
Inflammation
Clinical Deterioration
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Disease Progression
Disease Attributes