280
Participants
Start Date
July 29, 2021
Primary Completion Date
February 6, 2024
Study Completion Date
April 27, 2024
Anakinra or rhIFNγ
In hyper-inflammation anakinra three times daily (every eight hours) for 15 days and sc 0.5 ml N/S 0.9% every other day for 15 days. In immunoparalysis IV 20 ml N/S 0.9% (10ml for patients with creatinine clearance lower than 30ml/min) three times daily (every eight hours) for 15 days and sc rhIFNγ every other day for 15 days.
Placebo
20ml (10ml for patients with creatinine clearance lower than 30ml/min) intravenous (IV) 0.9% saline (N/S) three times daily (every eight hours) for 15 days and 0.5 ml subcutaneous (sc) 1ml 0.9% N/S every other day for a total of 15 days
1ST Department of Internal Medicine, Evangelismos General Hospital, Athens
1st Department of Pulmonary Medicine and Intensive Care Unit, Athens
3rd University Department of Internal Medicine, General Hospital of Chest Diseases of Athens SOTIRIA, Athens
New Intensive Care Unit, SOTIRIA Athens General Hospital of Chest Diseases, Athens
General Hospital of Athens LAIKO - Intensive Care Unit, Athens
Intensive Care Unit of Center for Respiratory Failure, General Hospital of Chest Diseases of Athens SOTIRIA, Athens
2nd Department of Critical Care Medicine, ATTIKON University Hospital, Athens
"4th Department of Internal Medicine, Attikon University Hospital, National and Kapodistrian University of Athens, Medical School", Athens
Intensive Care Unit, Center for Accident Rehabilitation (KAT) of Athens, Athens
Intensive Care Unit, General Hospital ASKLEPIEIO Voulas, Athens
Intensive Care Unit, TZANEIO Piraeus General Hospital, Piraeus
"Intensive Care Unit, Latsio, Thriasio Elefsis General Hospital", Elefsina
"Intensive Care Unit, Koutlimbaneio & Triantafylleio Larissa General Hospital", Larissa
Department of Internal Medicine, Larissa University Hospital, Larissa
General Hospital of Karditsa Intensive Care Unit, Karditsa
Intensive Care Unit, Ioannina University Hospital, Ioannina
Department of Anesthesiology and Intensive Care Medicine, University General Hospital of Thessaloniki AHEPA, Thessaloniki
Intensive Care Unit, 424 General Military Training Hospital, Thessaloniki
General Hospital of Thessaloniki, Papageorgiou- Intensive Care Unit, Thessaloniki
Intensive Care Unit, Alexandroupolis University Hospital, Alexandroupoli
Intensive Care Unit, Jena University Hospital, Jena
2nd Department of Internal Medicine, Attikon University Hospital, Athens
5th Department of Internal Medicine, Evangelismos General Hospital, Athens
General Oncological Hospital of Kifisia Oi Agioi Anargyroi - Clinic of Intensive Care and Pulmonary Diseases Department of Nursing, University of Athens, Athens
Greece Intensive Care Unit General Hospital of Athens Korgialeneio, Athens
Greece Intensive Care Unit University General Hospital of Heraklion, Heraklion
"Infectious Diseases Department, Iuliu Hatieganu'' University of Medicine and Pharmacy Cluj-Napoca", Cluj-Napoca
Intensive Care Unit, Agios Dimitrios General Hospital, Thessaloniki
Intensive Care Unit, G. Gennimatas General Hospital, Thessaloniki
Intensive Care Unit, Theageneio Oncological Hospital of Thessaloniki, Thessaloniki
Intensive Care Unit, Ippokrateion General Hospital, Thessaloniki
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome
Department of Internal Medicine and Infectious Diseases, Amsterdam Medical Center, Amsterdam
Intensive Care Unit, University Medical Center Radboud, Nijmegen
Intensive Care Unit, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne
Hellenic Institute for the Study of Sepsis
OTHER