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Trial - NCT05518474


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

Not reported

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"}]