| Trial registration number
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IRCT20120703010178N22 |
Full text link
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/49850
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First author
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Hassan Yazdan Panah
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Contact
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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yazdanpanah@sbmu.ac.ir
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Registration date
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2020-12-07
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Recruitment status
Last imported at : Dec. 21, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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multi-center
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Study aim
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Prevention
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Inclusion criteria
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Exposure and close contact (defined as being within 6 feet for a period of 15 minutes or more in a 24 hour period or 5 minutes or more for healthcare associated exposure) to a COVID-19 case within 4 days before entering the study
must agree not to enroll in another investigational study prior to completion of Day 14 of study
Individuals who have the ability to understand and desire to sign the informed consent
Age of 18 years or more
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Exclusion criteria
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Current Hospitalization
Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation
Hypersensitivity to bromhexine or any component of the formulation
Low risk in individuals in close contact (wearing face mask and eye shield)
Individuals with exposure of less than 15 minutes
Receipt of any medication for prophylaxis and treatment of 2019-nCoV
Patients with any related sign and symptoms of COVID-19
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Number of arms
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Dec. 8, 2020, 1 a.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 : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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18
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Inclusion age max
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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100
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Countries
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Close contacts to covid patients
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Severity scale
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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N/A
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Total sample size
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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1050
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primary outcome
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Incidence of COVID-19 disease
Ordinal Scale of COVID-19 disease severity
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Notes
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 3
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Arms
Last imported at : Dec. 8, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 240, "treatment_name": "Bromhexine hydrochloride", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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