This study is researching an experimental drug called REGN7544 (called "study drug"). The study is focused on adult patients (18 to 85 years) hospitalized due to a serious infection (called "sepsis") and receiving standard-of-care medications for low blood pressure (called "vasopressors") due to sepsis. The aim of the study is to see how safe, tolerable, and effective the study drug is by observing the effects on blood pressure and the total amount of vasopressor dose received during the stay in the hospital. The study is looking at several other research questions, including: * How the study drug changes the blood pressure and the amount of intravenous (IV) fluids given to participants with low blood pressure due to sepsis * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
76
Administered per the protocol
Administered per the protocol
University of Arizona
Tucson, Arizona, United States
Yale University
New Haven, Connecticut, United States
Emory University Hospital
Atlanta, Georgia, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Cumulative vasopressor dose
Time frame: Through 72 Hours
Occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 and higher Treatment-Emergent Adverse Events (TEAEs)
Time frame: Through 90 Days
Time-weighted average Mean Arterial Pressure (MAP)
Time frame: Baseline Over 4 Hours
Change in MAP
Time frame: Baseline, At 4 Hours
Proportion of surviving participants free of vasopressor(s)
Time frame: At 24, 48 and 72 Hours
Cumulative net fluid balance
Time frame: Through 72 Hours
Cumulative urine output
Time frame: Through 72 Hours
Cumulative fluid intake
Time frame: Through 72 Hours
Concentrations of REGN7544 in serum
Time frame: Through 90 Days
Incidence of Anti-Drug Antibodies (ADA) to REGN7544
Time frame: Through 90 Days
Magnitude of ADA to REGN7544
Time frame: Through 90 Days
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Harvard Medical School - Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
New York University Langone Health Brooklyn Hospital
Brooklyn, New York, United States
Bellevue Hospital
New York, New York, United States
New York University Langone Health Tisch-Kimmel Hospital
New York, New York, United States
Montefiore Medical Center - Weiler Hospital
The Bronx, New York, United States
...and 19 more locations