Trial registration number
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NCT04517123 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04517123
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First author
Last imported at : Jan. 15, 2022, 10 a.m.
Source : ClinicalTrials.gov
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Mahendra Damarla
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Contact
Last imported at : Jan. 15, 2022, 10 a.m.
Source : ClinicalTrials.gov
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mdamarl1@jhmi.edu
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2020-08-18
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Recruitment status
Last imported at : Jan. 15, 2022, 10 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:
- age ≥ 18 years
- covid-19 positive by nasopharyngeal swab or serostatus
- use of supplemental oxygen or respiratory rate ≥ 20
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Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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- bmi ≥ 45 kg/m2
- pregnancy
- chest tube placement
- hemodynamic instability with mean arterial pressure < 60 mmhg
- thoracic or abdominal wounds
- chest wall deformities
- vertebral column deformities that would preclude prone positioning
- facial trauma or surgery in the last 30 days
- established diagnosis of interstitial lung disease
- prior single or double lung transplant
- surgery for spine, femur, or pelvis in the last 3 months
- thoracic or cardiac surgery in the last 30 days
- pacemaker placement last 7 days
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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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Johns Hopkins University
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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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100
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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United States
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Moderate 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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3: Moderate disease at enrollment
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Total sample size
Last imported at : Jan. 15, 2022, 10 a.m.
Source : ClinicalTrials.gov
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35
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primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Occurrence of an escalation in respiratory related care (yes vs no)
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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 : March 27, 2022, 4 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "nan", "treatment_id": 1027, "treatment_name": "Prone position", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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