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Column | Value |
---|---|
Trial registration number | NCT05518474 |
Full text link
Last imported at : Aug. 27, 2022, 9 p.m. Source : ClinicalTrials.gov |
|
First author
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
|
Contact
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
Not reported |
Registration date
Last imported at : Aug. 27, 2022, 9 p.m. Source : ClinicalTrials.gov |
2022-08-26 |
Recruitment status
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
Terminated |
Study design
Last imported at : Aug. 27, 2022, 9 p.m. Source : ClinicalTrials.gov |
RCT |
Allocation
Last imported at : Aug. 27, 2022, 9 p.m. Source : ClinicalTrials.gov |
Randomized |
Design
Last imported at : Aug. 27, 2022, 9 p.m. Source : ClinicalTrials.gov |
Parallel |
Masking
Last imported at : Aug. 27, 2022, 9 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 : Aug. 27, 2022, 9 p.m. Source : ClinicalTrials.gov |
Treatment |
Inclusion criteria
Last imported at : Aug. 27, 2022, 9 p.m. Source : ClinicalTrials.gov |
inclusion criteria: age ≥18 years positive sars-cov-2 pcr test presence of two or more of the following criteria: age>55 years fever by history or at presentation cough dyspnea/shortness of breath fatigue necessitating daytime bed rest one or more of the following medical conditions: hypertension diabetes cardiovascular disease chronic lung disease chronic kidney disease obesity (bmi≥30kg/m2) tachycardia > 110 bpm oxygen saturation <94% one or more of the following laboratory abnormalities: lymphocytes <1500/microl esr > 100 mm/h crp > 10 mg/l d-dimer > 1000 ng/ml ldh > 240 u/l bilateral infiltrates or ground glass opacities on chest x-ray or ct scan socially and medically fit for discharge access to a smartphone |
Exclusion criteria
Last imported at : Aug. 27, 2022, 9 p.m. Source : ClinicalTrials.gov |
pregnancy >20/40 weeks body mass index (bmi) >40 kg/m2. skeletal deformities that interfere with proning developmental delay or cognitive impairment that would preclude patient cooperation other contraindications to proning including any of the following: recent abdominal surgery, active vomiting, acute intoxication. unlikely to adhere to the proning protocol according to the treating physician's judgment fully vaccinated for covid-19 |
Number of arms
Last imported at : Aug. 27, 2022, 9 p.m. Source : ClinicalTrials.gov |
2 |
Funding
Last imported at : Aug. 27, 2022, 9 p.m. Source : ClinicalTrials.gov |
Unity Health Toronto |
Inclusion age min
Last imported at : Aug. 27, 2022, 9 p.m. Source : ClinicalTrials.gov |
18 |
Inclusion age max
Last imported at : Aug. 27, 2022, 9 p.m. Source : ClinicalTrials.gov |
100 |
Countries
Last imported at : Aug. 27, 2022, 9 p.m. Source : ClinicalTrials.gov |
Canada |
Type of patients
Last imported at : Aug. 27, 2022, 9 p.m. Source : ClinicalTrials.gov |
Moderate/severe disease at enrollment |
Severity scale
Last imported at : Aug. 27, 2022, 9 p.m. Source : ClinicalTrials.gov |
4: Moderate/severe disease at enrollment |
Total sample size
Last imported at : May 12, 2023, noon Source : ClinicalTrials.gov |
11 |
primary outcome
Last imported at : Aug. 27, 2022, 9 p.m. Source : ClinicalTrials.gov |
Composite of hospitalization and all cause mortality |
Notes
Last imported at : Aug. 27, 2022, 9 p.m. Source : ClinicalTrials.gov |
None |
Phase
Last imported at : Aug. 27, 2022, 9 p.m. Source : ClinicalTrials.gov |
Not reported |
Arms
Last imported at : Aug. 27, 2022, 9 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 1181, "treatment_name": "Self-prone positioning", "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"}] |