| Trial registration number
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IRCT20200408046987N3 |
Full text link
Last imported at : Dec. 7, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/51999
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First author
Last imported at : Dec. 7, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Morteza Shakhsi Niaee
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Contact
Last imported at : Dec. 7, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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dr.niaee@gmail.com
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Registration date
Last imported at : Dec. 7, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2020-12-06
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Recruitment status
Last imported at : Dec. 30, 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. 7, 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. 7, 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. 7, 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. 7, 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. 7, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
multi-center
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Study aim
Last imported at : Dec. 7, 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. 7, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Healthy individuals exposed directly and constantly with COVID-19 patients.
COVID-19 patients who their disease is confirmed by RT-PCR test and low to moderate severity(Grade<3).
Patients with O2 saturation>94 who fit outpatient protocol.
Having consent for participating in study
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Exclusion criteria
Last imported at : Dec. 7, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Pregnant or breastfeeding women
individuals with a certain CNS disease
Individuals with an uncontrolled disease(Asthma, COPD, cardiovascular disease, diabetes, Kidney or Liver dysfunction, Cancer, Hepatitis, AIDS, Immunodeficiency)
Patients receiving immuno suppressive drugs
individuals receiving any P-450 or P-gp blockers or any medication interacting with ivermectin
patients under antiviral therapy
individuals receiving any Corticosteroid(Inhaling, PO or Injection)
any known sensitivity to Ivermectin or starch or history of lactose intolerability(for Placebo)
individuals with positive SARS-CoV-2 specific antibody
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Number of arms
Last imported at : Dec. 7, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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3
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Funding
Last imported at : Dec. 7, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Akam Tejarat Fartak Farasoo Company
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Inclusion age min
Last imported at : Dec. 7, 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. 7, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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65
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Countries
Last imported at : Dec. 7, 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. 7, 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. 7, 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. 7, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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800
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primary outcome
Last imported at : Dec. 7, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Percentage of patients in family members
Duration of illness
Severity of disease
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Notes
Last imported at : Dec. 7, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : Dec. 7, 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. 7, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
[{"arm_notes": "Close to contact group", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Mild disease", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Close to contact group and mild disease ", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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