| Trial registration number
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NCT04667286 |
Full text link
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04667286
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First author
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov
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stefano nava
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Contact
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov
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stefanava@gmail.com
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Registration date
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov
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2020-12-14
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Recruitment status
Last imported at : April 9, 2023, midnight
Source : ClinicalTrials.gov
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Unknown
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Study design
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov
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multi-center
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Study aim
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- confirmed covid-19 infection using pcr
- acute respiratory failure ( 200 <pao2/fio2 <300) and respiratory rate < 30 atti/min
- o2 therapy initiated <72 hrs
- informed consent
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Exclusion criteria
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov
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- glasgow coma scale (gcs) < 13
- ph< 7,45, paco2 >45 mmhg
- need for hfnc, cpap, niv or intubation
- hemodynamic instability increase of 80-90 mmhg or reduction of 30-40 mmhg in systolic
blood pressure
- severe arrythmia of myocardial infarction
- need for sedation
- intolerance to pp
- pregnancy
- body mass index (bmi) > 35 kg/m2.
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Number of arms
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
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Inclusion age min
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Italy
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Type of patients
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov
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Moderate/severe disease at enrollment
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Severity scale
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov
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4: Moderate/severe disease at enrollment
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Total sample size
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov
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100
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primary outcome
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov
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number of day free of ventilatory support
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Notes
Last imported at : Dec. 16, 2020, 10:02 a.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 : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 1027, "treatment_name": "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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