Acute Respiratory Distress SyndromePhase 2VANGARDNCT04433546
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).
A Phase 2 study testing Pemziviptadil (PB1046) in people with Acute Respiratory Distress Syndrome and Coronavirus, run by PhaseBio Pharmaceuticals Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Coronavirus, Hypoxic Respiratory Failure
- What is being tested?
- Pemziviptadil (PB1046)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Jul 2020to 2 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Baptist Health Research Institute
Jacksonville, Florida, 32207
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Adventist Healthcare White Oak Medical Center
Silver Spring, Maryland, 20904
About this study
Official title: A Randomized, Double-Blind, Parallel Group Study to Assess the Efficacy and Safety of Once Weekly Subcutaneous Injections of Pemziviptadil (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)
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.
Read the 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, whichever is shorter.
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
- Acute Respiratory Distress Syndrome, Coronavirus, Hypoxic Respiratory Failure, Hypoxemic Respiratory Failure, Respiratory Complication, Respiratory Insufficiency
- Being tested
- Pemziviptadil (PB1046), Low Dose (10 mg) Control
- Keywords
- Acute Respiratory Distress Syndrome (ARDS), Respiratory distress/failure, COVID
- Medical subject headings
- Respiratory Distress Syndrome, Coronavirus Infections, Respiratory Insufficiency, Pneumonia, Pulmonary Edema, Cytokine Release Syndrome, COVID-19, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pemziviptadil (PB1046)Drug
Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection
Low Dose (10 mg) ControlDrug
Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection (10 mg diluted in sodium chloride to match active drug volume)
| Study group | Role | What they receive |
|---|---|---|
| High Dose (100 mg) Group | Experimental | High: Pemziviptadil (PB1046) 100 mg subcutaneous (SC) weekly for 4 weeks or until hospital discharge Receives: Drug: Pemziviptadil (PB1046) |
| Middle Dose (40 mg) Group | Experimental | Middle: Pemziviptadil (PB1046) 40 mg SC weekly for 4 weeks or until hospital discharge Receives: Drug: Pemziviptadil (PB1046) |
| Low Dose (10 mg) Control Group | Placebo comparator | Low Control: Pemziviptadil (PB1046) 10 mg SC weekly for 4 weeks or until hospital discharge Receives: Drug: Low Dose (10 mg) Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical recovery from initiation of pemziviptadil (PB1046)
Measured: 28 days
Secondary outcomes (15)
Time to clinical recovery (being well enough for hospital discharge or returning to normal baseline activity level prior to discharge)
Measured: 28 days
Time to hospital discharge
Measured: Any time point between injection initiation and Day 28
All-cause mortality
Measured: 28 days
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
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
Measured: 28 days
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.
Measured: Any time point between injection initiation and Day 28
Change from baseline in cardiac marker troponin I (TrI)
Measured: Any time point between injection initiation and Day 35+7
Change from baseline in cardiac marker NT-proBNP/BNP
Measured: Any time point between injection initiation and Day 35+7
Change from baseline in TNF alpha
Measured: Any time point between injection initiation and Day 35+7
Change from baseline in IL-1
Measured: Any time point between injection initiation and Day 35+7
Change from baseline in IL-6
Measured: Any time point between injection initiation and Day 35+7
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 pemziviptadil (PB1046).
Measured: Any time point between injection initiation and Day 35+7
Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by vital signs and their relationship to pemziviptadil (PB1046)
Measured: Any time point between injection initiation and Day 35+7
Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by laboratory results and their relationship to pemziviptadil (PB1046)
Measured: Any time point between injection initiation and Day 35+7
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 pemziviptadil (PB1046)
Measured: Any time point between injection initiation and Day 35+7
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 pemziviptadil (PB1046)
Measured: Any time point between injection initiation and Day 35+7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start15 Jul 2020
- Primary completion2 Dec 2020
- Study completion2 Dec 2020
Why it stopped: Company no longer pursing indication
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhaseBio Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433546
- Sponsor's protocol ID
- PB1046-PT-CL-0007
- Acronym
- VANGARD
- Status last verified
- Dec 2020
- First submitted
- 28 May 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel Group Study to Assess the Efficacy and Safety of Once Weekly Subcutaneous Injections of Pemziviptadil (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)
- ClinicalTrials.gov ID
- NCT04433546
- Acronym / sponsor ID
- VANGARD / PB1046-PT-CL-0007
- Conditions
- Acute Respiratory Distress Syndrome, Coronavirus, Hypoxic Respiratory Failure, Hypoxemic Respiratory Failure, Respiratory Complication, Respiratory Insufficiency
- Keywords
- Acute Respiratory Distress Syndrome (ARDS), Respiratory distress/failure, COVID
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company no longer pursing indication
- Enrolment
- 54 participants (actual)
- Lead sponsor
- PhaseBio Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 2 Dec 2020 (actual)
- Study completion
- 2 Dec 2020 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, whichever is shorter.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Dose (100 mg) Group | Experimental | Drug: Pemziviptadil (PB1046)High: Pemziviptadil (PB1046) 100 mg subcutaneous (SC) weekly for 4 weeks or until hospital discharge |
| Middle Dose (40 mg) Group | Experimental | Drug: Pemziviptadil (PB1046)Middle: Pemziviptadil (PB1046) 40 mg SC weekly for 4 weeks or until hospital discharge |
| Low Dose (10 mg) Control Group | Placebo comparator | Drug: Low Dose (10 mg) ControlLow Control: Pemziviptadil (PB1046) 10 mg SC weekly for 4 weeks or until hospital discharge |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pemziviptadil (PB1046)Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection | Drug | High Dose (100 mg) Group, Middle Dose (40 mg) Group |
| Low Dose (10 mg) ControlPemziviptadil (PB1046), Once Weekly Subcutaneous Injection (10 mg diluted in sodium chloride to match active drug volume) | Drug | Low Dose (10 mg) Control Group |
Primary outcome
Time to clinical recovery from initiation of pemziviptadil (PB1046)
Time frame: 28 days
15 secondary outcomes
Time to clinical recovery (being well enough for hospital discharge or returning to normal baseline activity level prior to discharge)
Time frame: 28 days
Time to hospital discharge
Time frame: Any time point between injection initiation and Day 28
All-cause mortality
Time frame: 28 days
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
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
Change from baseline in cardiac marker troponin I (TrI)
Time frame: Any time point between injection initiation and Day 35+7
Change from baseline in cardiac marker NT-proBNP/BNP
Time frame: Any time point between injection initiation and Day 35+7
Change from baseline in TNF alpha
Time frame: Any time point between injection initiation and Day 35+7
Change from baseline in IL-1
Time frame: Any time point between injection initiation and Day 35+7
Change from baseline in IL-6
Time frame: Any time point between injection initiation and Day 35+7
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 pemziviptadil (PB1046).
Time frame: Any time point between injection initiation and Day 35+7
Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by vital signs and their relationship to pemziviptadil (PB1046)
Time frame: Any time point between injection initiation and Day 35+7
Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by laboratory results and their relationship to pemziviptadil (PB1046)
Time frame: Any time point between injection initiation and Day 35+7
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 pemziviptadil (PB1046)
Time frame: Any time point between injection initiation and Day 35+7
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 pemziviptadil (PB1046)
Time frame: Any time point between injection initiation and Day 35+7
Results and safety
The study was stopped early (reason given: Company no longer pursing indication). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemziviptadil (PB1046) in people with Acute Respiratory Distress Syndrome and Coronavirus, run by PhaseBio Pharmaceuticals Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Company no longer pursing indication). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to clinical recovery from initiation of pemziviptadil (PB1046) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.