104
Participants
Start Date
December 16, 2020
Primary Completion Date
July 19, 2022
Study Completion Date
July 25, 2022
Standard of care
Standard of Care (SOC) includes any supportive measures applied in hospital, specifically on an intensive care unit (ICU), such as for example the use of non-invasive or invasive ventilation, oxygen masks, haemodynamic support, if needed, sedation, as well as medical therapies commonly used in patients suffering from acute respiratory distress syndrome (ARDS) or its complications. SOC should include best possible treatment regimen established locally and should be in line with current guidelines for ARDS treatment.
Alteplase low dose
0.3 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.02 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5). One optional additional infusion of 0.3 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement.
Alteplase high dose
0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement.
ULB Hopital Erasme, Brussels
Wiener Gesundheitsverbund Klinik Favoriten, Vienna
Ottignies - HOSP St-Pierre, Ottignies
Centre Hospitalier Universitaire de Liège, Liège
LKH Klagenfurt am Woerthersee, Klagenfurt
Hospital Puerta del Mar, Cadiz
Istituto Clinico Humanitas, Rozzano (MI)
IRCCS San Raffaele, Milan
Hospital Cardiologica Aguascalientes, Aguascalientes
Medizinische Hochschule Hannover, Hanover
Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi, Izmir
Petrus-Krankenhaus, Wuppertal
HOP Hôtel-Dieu, Nantes
HOP Robert Debré, Reims
HOP Roger Salengro, Lille
HOP Civil, Strasbourg
Universitätsklinikum Mannheim GmbH, Mannheim
Universitätsklinikum Heidelberg, Heidelberg
HOP Cochin, Paris
HOP Européen G. Pompidou, Paris
HOP Melun-Sénart, Melun
Klinikum der Universität München - Campus Großhadern, München
HOP Bicêtre, Le Kremlin-Bicêtre
Hospital Miri, Miri
City Clinical Hospital # 40 of the Moscow Health Department, Moscow
Moscow 1st State Med.Univ.n.a.I.M.Sechenov, Moscow
"State Budget Institution of Healthcare Leningradskaya region Kirovskaya Interdistrict Hospital", Saint Petersburg
City Clinical Emergency Hospital, Ryazan
King George Hospital, Visakhapatnam
Hospital Mae de Deus, Porto Alegre
Universitätsklinikum Leipzig, Leipzig
Gelre Ziekenhuizen Apeldoorn, Apeldoorn
Rijnstate Hospital, Arnhem
Canisius-Wilhelmina ziekenhuis, Nijmegen
Hospital del Mar, Barcelona
Hospital Vall d'Hebron, Barcelona
CS Parc Taulí, Sabadell
Lead Sponsor
Boehringer Ingelheim
INDUSTRY