Trial registration number
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IRCT20201012049010N2 |
Full text link
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/60688
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First author
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Dr. Afshin Zaraghi
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Contact
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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pr-office@sbu.ac.ir
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Registration date
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2022-03-04
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Recruitment status
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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single-center
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Study aim
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Older age equals 18 years
Patients with Covid 19 (based on diagnostic methods of the latest published version of the National Protocol)
Need to be admitted to a non-intensive care unit
Hospitalization in the last 6 hours
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Exclusion criteria
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Any case of CNS disorder that interferes with patient communication and educability
Need to be admitted to the intensive care unit at the time of enrollment
history of lung disease
sPo2<94% (at room air)
Participation in any other clinical trial of an experimental treatment for COVID-19
pregnant woman or man who his spouse is pregnant
history of CHF
Requiring mechanical ventilation at screening
Evidence of multi-organ failure
Recent of ACS
no willingness for enrollment
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Number of arms
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Shahid Beheshti University of Medical Sciences
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Inclusion age min
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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18
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Inclusion age max
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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100
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Countries
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : March 4, 2022, 10 p.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 : March 4, 2022, 10 p.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 : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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160
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primary outcome
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Clinical recovery rate
Respiratory rate
Peripheral blood oxygen saturation in oxygen therapy
Percentage of peripheral blood oxygen saturation in the absence of oxygen therapy
Intravenous carbon dioxide content
Intravenous oxygen level
Intravenous bicarbonate
Intravenous blood pH
Severity of dyspnea
Blood pressure
Sex
Stress level
Duration of hospitalization
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Notes
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 3
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Arms
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 230, "treatment_name": "Breathing exercise", "treatment_type": "Rehabilitation", "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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