| Trial registration number
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IRCT20210222050457N1 |
Full text link
Last imported at : April 21, 2021, 2 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/54525
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First author
Last imported at : April 21, 2021, 2 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Fatemeh Shirvanizadeh Arani
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Contact
Last imported at : April 21, 2021, 2 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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dr.shirvanizade@gmail.com
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Registration date
Last imported at : April 21, 2021, 2 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2021-04-20
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Recruitment status
Last imported at : May 4, 2021, 2 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : April 21, 2021, 2 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
RCT
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Allocation
Last imported at : April 21, 2021, 2 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : April 21, 2021, 2 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : April 21, 2021, 2 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Open label
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Center
Last imported at : April 21, 2021, 2 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
single-center
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Study aim
Last imported at : April 21, 2021, 2 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Treatment
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Inclusion criteria
Last imported at : April 21, 2021, 2 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Male or female patients aged 18 to 75 years with COVID-19 who have been diagnosed with a lung scan, PCR, or clinical examination.
Obtaining informed consent from the patient or patient caregiver to participate in the study
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Exclusion criteria
Last imported at : April 21, 2021, 2 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Cancer patients undergoing chemotherapy
Patients with immunodeficiency diseases receiving immunomodulators
Patients with uncontrolled heart, kidney or liver failure
Women who are pregnant or breastfeeding
Patients with low level of consciousness who are not able to inhale the spray
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Number of arms
Last imported at : April 21, 2021, 2 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : April 21, 2021, 2 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Kashan University of Medical Sciences
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Inclusion age min
Last imported at : April 21, 2021, 2 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
18
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Inclusion age max
Last imported at : April 21, 2021, 2 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
75
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Countries
Last imported at : April 21, 2021, 2 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Iran
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Type of patients
Last imported at : April 21, 2021, 2 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 : April 21, 2021, 2 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 : April 21, 2021, 2 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
188
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primary outcome
Last imported at : April 21, 2021, 2 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Percentage of arterial oxygen saturation
Severity of cough
Shortness of breath
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Notes
Last imported at : April 21, 2021, 2 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
|
Phase
Last imported at : April 21, 2021, 2 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 1/Phase 2
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Arms
Last imported at : April 21, 2021, 2 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 2339, "treatment_name": "Phr-160", "treatment_type": "Respiratory agents", "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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