COVID-19 trials registries data warehouse

 Return to trial list

Trial - NCT04341285


Column Value
Trial registration number NCT04341285
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

First author
Last imported at : June 11, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Peter Rosenberger, Prof

Contact
Last imported at : June 11, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

peter.rosenberger@med.uni-tuebingen.de

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-04-10

Recruitment status
Last imported at : June 11, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Withdrawn

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - covid-19positive(+) ards as defined according to the berlin definition - ratio of partial pressure arterial oxygen and fraction of inspired oxygen (pao2/ fio2) ≤100 - bilateral opacities consistent with pulmonary edema on frontal chest radiograph - requirement for positive pressure ventilation via an endotracheal tube or non-invasive ventilation - no clinical evidence of left atrial hypertension, or if measured, a pulmonary arterial wedge pressure (paop) less than or equal to 18 mmhg. - ≤ 7 days from the initiation of mechanical ventilation at the time of randomization. - patients must be enrolled within 96 hours of onset of ards -

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- covid-19negative(-) ards - age less than 18 years - more than 7 days since initiation of mechanical ventilation - more than 96 hours since meeting ards criteria - patient, surrogate or physician not committed to full intensive care support. - pregnancy

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

University Hospital Tuebingen

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Germany

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Severe/critical disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

7: Severe/critical disease at enrollment

Total sample size
Last imported at : June 11, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

28 day all cause mortality

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "Early implantation", "treatment_id": 440, "treatment_name": "Ecmo", "treatment_type": "Life support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Late implantation", "treatment_id": 440, "treatment_name": "Ecmo", "treatment_type": "Life support", "pharmacological_treatment": "Non pharmacological treatment"}]