| Trial registration number
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NCT04395144 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04395144
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First author
Last imported at : March 25, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Ivan Pavlov, MD
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Contact
Last imported at : March 25, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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ivan.pavlov.md@gmail.com
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2020-05-20
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Recruitment status
Last imported at : March 25, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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multi-center
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- covid-19, either confirmed by sars-cov-2 assay, or clinically suspected, with results
of the assay pending;
- lung infiltrates documented on chest x-ray or chest ct-scan;
- significant respiratory distress that requires treatment with hfno.
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Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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- unable to consent;
- unable to prone;
- indication for immediate endotracheal intubation and mechanical ventilation;
- contraindication to prone positioning (severe obesity, abdominal wound, pregnancy,
unstable pelvic/spinal lesions, vomiting, etc.);
- comfort care or imminent expectation of death.
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Hôpital de Verdun
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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None
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Canada
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Severe disease at enrollment
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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6: Severe disease at enrollment
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Total sample size
Last imported at : March 25, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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13
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primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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Not reported
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 1751, "treatment_name": "Awake prone position", "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"}]
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