| Trial registration number
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IRCT20201223049816N1 |
Full text link
Last imported at : Jan. 12, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/53342
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First author
Last imported at : Jan. 12, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Mostafa Ghanei
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Contact
Last imported at : Jan. 12, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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mghaneister@gmail.com
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Registration date
Last imported at : Jan. 12, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-01-11
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Recruitment status
Last imported at : March 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : Jan. 12, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
RCT
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Allocation
Last imported at : Jan. 12, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Jan. 12, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Jan. 12, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Open label
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Center
Last imported at : Jan. 12, 2021, 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 : Jan. 12, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Jan. 12, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Both sexes
Ages 15-75
Oxygen saturation percentage between 88 and 93%.
Confirmation of 19 patients using RTPCR.
Confirmation of Covid-19 using CT scan
Signing a informed consent form
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Exclusion criteria
Last imported at : Jan. 12, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Attending another trial in the last three months
pregnancy/lactation
drug sensitivity to the ingredients in the intervention
very high severity of the disease in the emergency room (consciousness less than 15 / oxygen concentration less than 88%, etc)
history of chronic respiratory disease
Previous pulmonary embolism (last three months)
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Number of arms
Last imported at : Jan. 12, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Jan. 12, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Bagheiat-allah University of Medical Sciences
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Inclusion age min
Last imported at : Jan. 12, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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15
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Inclusion age max
Last imported at : Jan. 12, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
75
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Countries
Last imported at : Jan. 12, 2021, 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 : Jan. 12, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Severe disease at enrollment
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Severity scale
Last imported at : Jan. 12, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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6: Severe disease at enrollment
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Total sample size
Last imported at : Jan. 12, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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240
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primary outcome
Last imported at : Jan. 12, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Percentage of oxygen saturation in two intervention groups after randomization
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Notes
Last imported at : Jan. 12, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : Jan. 12, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 1
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Arms
Last imported at : Jan. 12, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
[{"arm_notes": "Spray", "treatment_id": 985, "treatment_name": "Phr160", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "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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