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Trial - NCT04358939


Column Value
Trial registration number NCT04358939
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04358939

First author
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Yonatan PEREZ, MD

Contact
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

y.perez@chu-tours.fr

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

2020-04-24

Recruitment status
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Completed

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

multi-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: - adult patient - with covid-19 pneumonia according to the diagnostic criteria in effect at the time of inclusion or very highly suspected. - patient treated with nasal high-flow - mild, moderate or severe ards: bilateral radiological opacities not fully explained by effusions, atelectasis or nodules; acute hypoxemia with worsening within the previous 7 days, not fully explained by left ventricular failure; pao2/fio2 ratio < 300 mmhg (or equivalent spo2/fio2). - covered by or having the rights to french social security - informed consent

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

pregnant or breastfeeding woman - indication for immediate tracheal intubation - progressive significant acute circulatory insufficiency - impaired alertness, confusion, restlessness - body mass index > 40 kg/m2 - thoracic trauma or other contraindication to prone position - pneumothorax with single anterior thoracic drain and persistent bubbling - vulnerable person: safeguard of justice, guardianship or authorship known at inclusion

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, Tours

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

France

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 : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

405

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

Therapeutic failure within 14 days of randomization

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": "Prone decubitus", "treatment_id": 1013, "treatment_name": "Postural positioning", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Supine", "treatment_id": 1013, "treatment_name": "Postural positioning", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}]