| Trial registration number
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IRCT20210213050344N1 |
Full text link
Last imported at : April 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/54710
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First author
Last imported at : April 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Dr. Abdul Rasool Hemmati
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Contact
Last imported at : April 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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r.hemmati@gmail.com
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Registration date
Last imported at : April 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-04-06
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Recruitment status
Last imported at : May 11, 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 : April 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : April 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : April 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : April 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : April 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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single-center
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Study aim
Last imported at : April 7, 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 : April 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Clients to selected outpatient treatment centers in Shiraz
Only mild symptoms and clinical manifestations (including: fever less than 38 degrees, sore throat with or without dry cough, chills, headache, loss of taste and smell, nausea, vomiting, anorexia, diarrhea, body aches, weakness and Excessive fatigue, persistent yard symptoms)
Positive RT-PCR test result
Age between 18 and 80 years
People with underlying disease (to evaluate the effectiveness of the drug on people with underlying disease)
Individuals who have completed and signed the written consent to participate in the project
Blood oxygen level 93% and above (O2 sat ≥ 93%)
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Exclusion criteria
Last imported at : April 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Pregnant mothers
Breastfeeding mothers
Severe liver disease
Severe kidney disease
Severe lung disease
HIV Positive patients
Chronic obstructive pulmonary disease (COPD)
Participate in another RCT
Dissatisfaction with participating in the study
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Number of arms
Last imported at : April 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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3
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Funding
Last imported at : April 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Shiraz University of Medical Sciences
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Inclusion age min
Last imported at : April 7, 2021, 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 : April 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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80
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Countries
Last imported at : April 7, 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 : April 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Mild/moderate disease at enrollment
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Severity scale
Last imported at : April 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2: Mild/moderate disease at enrollment
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Total sample size
Last imported at : April 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
375
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primary outcome
Last imported at : April 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
The trend of clinical symptoms of Covid-19 disease
Blood oxygen level (O2 Saturation)
Hospitalization
Requires intubation or ICU
Death
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Notes
Last imported at : April 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : April 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 3
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Arms
Last imported at : April 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "4x3mg on day 1", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "4x3mg on day 1 and day 2", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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