Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Regeneron Pharmaceuticals
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Proven or suspected infection defined as administration or planned administration of antimicrobial therapy within the screening period
2. 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
You may not be if
1. Unable to obtain informed consent by participant or Legally Authorized Representative (LAR)
2. Clinical status requires vasopressor and/or Blood Pressure (BP) management inconsistent with the study protocol
3. Primary cause of hypotension suspected to be due to non-sepsis cause (eg, hemorrhage, burns, or cardiogenic shock), including shock after cardiac arrest
4. Ejection fraction \<20% in the most recent known echocardiogram
5. Acute coronary syndrome based on clinical symptoms and/or electrocardiogram (ECG) during hospitalization
6. History of hospitalization due to heart failure, myocardial infarction, stroke, clinically significant ventricular arrhythmia, transient ischemic attack, or unstable angina within the preceding 3 months
7. Any prior diagnosis of severe pulmonary hypertension, as defined in the protocol
8. Receiving 3 or more vasopressors or exceeding the maximal combined dose as defined in the protocol, during the screening period or at the time of study drug administration
9. Received bone marrow transplant during the preceding 6 months or chemotherapy during the preceding 30 days for lymphoma or leukemia
Clareo Health | A Study of REGN7544 for the Treatment in Adult Patients With Sepsis-Induced Hypotension
