A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of REGN7544, an Antagonist Monoclonal Antibody to NPR1, in Patients With Sepsis-Induced Hypotension
Status: Recruiting
Location: See all (25) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Proven or suspected infection defined as administration or planned administration of antimicrobial therapy within the screening period
• Sepsis-induced hypotension that has not responded to Intravenous (IV) fluids, receiving 1 or 2 vasopressors and maintaining a Mean Arterial Pressure (MAP) of ≥ 65 mm Hg for at least 2 consecutive hours immediately prior to randomization, as defined in the protocol
Locations
United States
Connecticut
Yale University
RECRUITING
New Haven
Georgia
Emory University Hospital
RECRUITING
Atlanta
Massachusetts
Harvard Medical School - Beth Israel Deaconess Medical Center
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
North Carolina
Atrium Health
RECRUITING
Winston-salem
New York
Montefiore Medical Center - Moses Campus
RECRUITING
The Bronx
Montefiore Medical Center - Weiler Hospital
RECRUITING
The Bronx
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
South Carolina
MUSC SCTR Research Nexus Clinic and Lab
RECRUITING
Charleston
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Utah
Intermountain Medical Center - Murray (Pulmonary Medicine)
RECRUITING
Murray
Other Locations
France
Centre Hospitalier Universitaire Angers
RECRUITING
Angers
Raymond Poincare University Hospital
RECRUITING
Garches
Centre Hospitalier Departemental (CHD) Vendee
RECRUITING
La Roche-sur-yon
Paris-Saclay University Hospitals
RECRUITING
Le Kremlin-bicêtre
Centre Hospitalier Le Mans
RECRUITING
Le Mans
CHU Dupuytren
RECRUITING
Limoges
CHU Nantes
RECRUITING
Nantes
Centre Hospitalier Universitaire d'Orleans
RECRUITING
Orléans
Hopital Cochin
RECRUITING
Paris
CHU de Reims Hopital Robert Debre
RECRUITING
Reims
Hopitaux Universitaires de Strasbourg
RECRUITING
Strasbourg
Centre Hospitalier Regional Universaitaire de Tours (CHRU de Tours)