| Trial registration number
|
IRCT20201024049134N1 |
Full text link
Last imported at : Nov. 3, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/51847
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First author
Last imported at : Nov. 3, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Reza Ghadimi
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Contact
Last imported at : Nov. 3, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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rezaghadimi@yahoo.com
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Registration date
Last imported at : Nov. 3, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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2020-11-02
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Recruitment status
Last imported at : March 19, 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 : Nov. 3, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Nov. 3, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Nov. 3, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Nov. 3, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : Nov. 3, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
|
single-center
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Study aim
Last imported at : Nov. 3, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Nov. 3, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
|
People over the age of 65 who are in high-risk groups (with a history of high blood pressure, diabetes, BMI> 30, COPD, cancer, and etc.)
Confirmation of the diagnosis of COVID-19 by chest CT scan and/or rt-PCR
Signing an informed consent form
|
Exclusion criteria
Last imported at : Nov. 3, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
|
History of allergies to these drugs
Use arbidol before hospitalization
Pregnant women
Respiratory failure and need for mechanical ventilation
Renal and/or hepatic failure
Anemia and thrombocytopenia
Coagulopathy
Autoimmune or immune deficiency disorders
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Number of arms
Last imported at : Nov. 3, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Nov. 3, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Babol University of Medical Sciences
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Inclusion age min
Last imported at : Nov. 3, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
|
65
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Inclusion age max
Last imported at : Nov. 3, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
|
100
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Countries
Last imported at : Nov. 3, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : Nov. 3, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Mild disease at enrollment
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Severity scale
Last imported at : Nov. 3, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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1: Mild disease at enrollment
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Total sample size
Last imported at : Jan. 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
80
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primary outcome
Last imported at : Nov. 3, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Time of the removal of the symptoms
hospitalization required
Life-threatening conditions
Death
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Notes
Last imported at : Nov. 3, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : Jan. 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 2/Phase 3
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Arms
Last imported at : Nov. 3, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 1336, "treatment_name": "Umifenovir", "treatment_type": "Antivirals", "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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