COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04433546

PhaseBio Pharmaceuticals Inc. - Clinical Trials

Clinicaltrials@phasebio.com

2020-06-16

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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

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

3

PhaseBio Pharmaceuticals Inc.

18

85

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

54

Time to clinical recovery from initiation of pemziviptadil (PB1046)

None

Phase 2

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