Emapalumab Treatment For Anticipated Clinical Benefit In Sepsis Driven By The Interferon-Gamma Endotype (The EMBRACE Trial)

PHASE2RecruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

March 22, 2025

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2026

Conditions
Sepsis
Interventions
DRUG

Emapalumab-Izsg

The drug is administered at a dose of 6mg/kg of body weight on day 0 and repeated dosing of 3mg/kg of body weight is provisioned for days 3, 6, 9, 12, 15, 19, 23 and 27 provided that the stopping rule does not apply.

DRUG

Emapalumab-Izsg

The drug is administered at a dose of 6mg/kg of body weight on day 0, 6mg/kg of body weight on day 3, 6mg/kg of body weight on day 6 and repeated dosing of 3mg/kg of body weight is provisioned for days 9, 12, 15, 19, 23 and 27 provided that the stopping rule does not apply.

DRUG

Placebo

250ml of 0.9% sodium chloride. The drug is administered on day 0 and repeated dosing is provisioned for days 3, 6, 9, 12, 15, 19, 23 and 27 provided that the stopping rule does not apply

Trial Locations (24)

Unknown

RECRUITING

1st Department of Internal Medicine, Thriasio Elefsis General Hospital, Elefsina

RECRUITING

Clinic of Intensive Care and Pulmonary Diseases, Aghioi Anargyroi Kifissia General Oncologic Hospital, Kifissia

RECRUITING

Intensive Care Unit, Herakleion University General Hospital, Heraklion

RECRUITING

Intensive Care Unit, Alexandroupolis University General Hospital, Alexandroupoli

RECRUITING

3rd University Department of Internal Medicine, Sotiria Chest Diseases Athens General Hospital, Athens

RECRUITING

4th Department of Internal Medicine, ATTIKON University General Hospital, Athens

RECRUITING

Intensive Care Unit I, KAT Attica General Hospital, Athens

RECRUITING

Intensive Care Unit of 1st University Department Respiratory Medicine, Sotiria Chest Diseases Athens General Hospital, Athens

RECRUITING

Intensive Care Unit of Center for Respiratory Failure, Sotiria Chest Diseases Athens General Hospital, Athens

RECRUITING

Intensive Care Unit, Asklipieio Voulas General Hospital, Athens

RECRUITING

Intensive Care Unit, Ippokrateio Athens General Hospital, Athens

RECRUITING

Intensive Care Unit, Korgialeneio-Benakeio HRC Athens General Hospital, Athens

RECRUITING

Intensive Care Unit, Laiko Athens General Hospital, Athens

RECRUITING

New Multivalent Intensive Care Unit, Sotiria Chest Diseases Athens General Hospital, Athens

RECRUITING

Ηigh Dependency Unit of Department of Clinical Therapeutics, Alexandra Athens General Hospital, Athens

RECRUITING

Intensive Care Unit, Patras University General Hospital, Pátrai

RECRUITING

1st Intensive Care Unit, G. Papanikolaou Thessaloniki General Hospital, Thessaloniki

RECRUITING

Department of Anesthesiology and Intensive Care, AHEPA Thessaloniki University General Hospital, Thessaloniki

NOT_YET_RECRUITING

Intensive Care Unit, 424 General Military Training Hospital, Thessaloniki

RECRUITING

Intensive Care Unit, Aghios Dimitrios Thessaloniki General Hospital, Thessaloniki

RECRUITING

Intensive Care Unit, G. Gennimatas Thessaloniki General Hospital, Thessaloniki

RECRUITING

Intensive Care Unit, Ippokrateio Thessaloniki General Hospital, Thessaloniki

RECRUITING

Intensive Care Unit, Papageorgiou Thessaloniki General Hospital, Thessaloniki

RECRUITING

Intensive Care Unit, Theageneio Thessaloniki Cancer Hospital, Thessaloniki

All Listed Sponsors
lead

Hellenic Institute for the Study of Sepsis

OTHER