ESTELLAREGN7544 Antibody for Sepsis-Induced Hypotension
REGN7544
+ PB
Cardiovascular Diseases
+ Hypotension
+ Vascular Diseases
Treatment Study
Summary
Study start date: May 5, 2025
Actual date on which the first participant was enrolled.This clinical trial is exploring a new experimental drug called REGN7544 for treating patients with sepsis-induced hypotension. Sepsis is a serious condition caused by an overwhelming infection, leading to dangerously low blood pressure. The study focuses on adults aged 18 to 85 who are hospitalized due to sepsis and are already receiving standard treatments to raise their blood pressure. The main goal is to determine if REGN7544 can safely and effectively help manage low blood pressure in these patients, which is a crucial aspect of their care. Participants in the study will receive REGN7544 in addition to their regular care and will be closely monitored to see how the drug affects their blood pressure and the amount of medication they need to stabilize it. Researchers will also track any side effects, how the drug behaves in the body over time, and whether the body develops antibodies against it, potentially impacting its effectiveness. The study involves regular blood tests and health evaluations to gather this information, ensuring a comprehensive understanding of the drug's impact on sepsis-related low blood pressure.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.76 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 29 locations
Montefiore Medical Center - Weiler Hospital
The Bronx, United StatesOpen Montefiore Medical Center - Weiler Hospital in Google MapsMontefiore Medical Center - Moses Campus
The Bronx, United StatesAtrium Health
Winston-Salem, United StatesCleveland Clinic Foundation
Cleveland, United States