| Trial registration number
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IRCT20200506047323N6 |
Full text link
Last imported at : Nov. 18, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/49501
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First author
Last imported at : Nov. 18, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Teamur Aghamolaei
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Contact
Last imported at : Nov. 18, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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mail@hums.ac.ir
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Registration date
Last imported at : Nov. 18, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2020-11-17
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Recruitment status
Last imported at : Feb. 16, 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. 18, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
RCT
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Allocation
Last imported at : Nov. 18, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Nov. 18, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Nov. 18, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Open label
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Center
Last imported at : Nov. 18, 2020, 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 : Nov. 18, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Treatment
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Inclusion criteria
Last imported at : Nov. 18, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Age ≥20 years old
Weight ≥35 kg
Positive polymerase chain reaction (PCR) test for COVID-19
Non-hospitalized mild as well as hospitalized moderate patients
Signed informed consent voluntarily and knowingly
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Exclusion criteria
Last imported at : Nov. 18, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Underlying diseases (AIDS, asthma, severe liver and kidney disease)
History of Loiasis
History of drug allergy to Ivermectin
Use of anticoagulants (e.g. warfarin) and ACE inhibitors (e.g. captopril)
Pregnancy or breastfeeding
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Number of arms
Last imported at : Nov. 18, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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3
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Funding
Last imported at : Nov. 18, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Bandare-abbas University of Medical Sciences
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Inclusion age min
Last imported at : Nov. 18, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
20
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Inclusion age max
Last imported at : Nov. 18, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
100
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Countries
Last imported at : Nov. 18, 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 : Nov. 18, 2020, 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 : Nov. 18, 2020, 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 : Nov. 18, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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120
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primary outcome
Last imported at : Nov. 18, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Length of hospital stay
Need for ICU
Need for mechanical ventilation
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Notes
Last imported at : Nov. 18, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
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Phase
Last imported at : Nov. 18, 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 : Nov. 18, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
[{"arm_notes": "Mild patients", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Moderate patients", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "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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