| Trial registration number
|
DRKS00028205 |
Full text link
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
http://www.drks.de/DRKS00028205
|
First author
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Simon Lindner
|
Contact
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
simon.lindner@umm.de
|
Registration date
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
2022-02-22
|
Recruitment status
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Not recruiting
|
Study design
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
RCT
|
Allocation
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Randomized
|
Design
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Parallel
|
Masking
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Open label
|
Center
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
single-center
|
Study aim
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Treatment
|
Inclusion criteria
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Written informed consent, Confirmed SARS-CoV-2 Infection, Moderate to severe ARDS (PaO2 / FiO2 < 200),
|
Exclusion criteria
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Currently pregnant, Participant with life expectancy of less than 6 months, Any medical contraindications or refusal by the individual or their legal representative to intubation and mechanical ventilation, Preexisting mechanical ventilation due to other conditions, Inability or unwillingness of individual or legal representative to give written informed consent.
|
Number of arms
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
2
|
Funding
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
I. Medizinische Klinik; Universitätsmedizin Mannheim
|
Inclusion age min
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
18
|
Inclusion age max
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
99
|
Countries
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Germany
|
Type of patients
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Critical disease at enrollment
|
Severity scale
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
8: Critical disease at enrollment
|
Total sample size
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
160
|
primary outcome
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Mortality
|
Notes
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
| Declared number of arm (2.0)
differs from found arms (3.0)
|
Phase
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Not reported
|
Arms
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
[{"arm_notes": "", "treatment_id": 775, "treatment_name": "Mechanical ventilation", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
|