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Trial - IRCT20201012049010N2


Column Value
Trial registration number IRCT20201012049010N2
Full text link
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Dr. Afshin Zaraghi

Contact
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

pr-office@sbu.ac.ir

Registration date
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2022-03-04

Recruitment status
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

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

Exclusion criteria
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

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

Number of arms
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Shahid Beheshti University of Medical Sciences

Inclusion age min
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Moderate/severe disease at enrollment

Severity scale
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

160

primary outcome
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

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

Notes
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 3

Arms
Last imported at : March 4, 2022, 10 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"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"}]