| Trial registration number
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IRCT20210424051061N1 |
Full text link
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/55790
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First author
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Dr. Kokab Basiri Moghaddam
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Contact
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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k.basiri@gmu.ac.ir
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Registration date
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-09-29
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Recruitment status
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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single-center
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Study aim
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Willingness to participate in the study
Age 20 -60 y/o
No history of cardiovascular disease such as hypertension, liver, kidney according to self-declaration
Need to prescribe oxygen and candidate for non-invasive respiratory assistance (NIV) according to physician (no need for intubation)
No ban on the use of masks
Definitive diagnosis of coronavirus infection by physician and laboratory results
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Exclusion criteria
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Need to intubate the patient immediately
Awareness level based on the Glasgow scale less than 15
Any change in the patient's condition that affects the course of treatment, for example blood pressure below 90 mmhg despite fluid therapy or the use of vasopressors
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Number of arms
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Gonabad University of Medical Sciences
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Inclusion age min
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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20
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Inclusion age max
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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60
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Countries
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Moderate/severe disease at enrollment
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Severity scale
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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4: Moderate/severe disease at enrollment
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Total sample size
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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46
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primary outcome
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Mean score of hemodynamic parameters
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Notes
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 2/Phase 3
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Arms
Last imported at : Sept. 30, 2021, 7:02 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 1941, "treatment_name": "Biphasic positive airway pressure (bipap)", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 350, "treatment_name": "Continuous positive airway pressure (cpap)", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}]
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