| Trial registration number
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IRCT20130812014333N147 |
Full text link
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/46853
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First author
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Dr. Farid Najafi
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Contact
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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fnajafi@kums.ac.ir
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Registration date
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2020-04-22
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Recruitment status
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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single-center
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Study aim
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Age over 18 years
Absolute lymphocyte count <1100 / ML or SaO2 <93
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Exclusion criteria
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Pregnancy or breast-feeding
The physician's decision that the trial is not in the patient's interest
Any circumstances that do not allow the treatment protocol to be followed easily
A history of known allergies to Sofosbuvir-Velp, Trifluoprazine, Lithium and Trihexyphenidyl
Drugs that their concomitant use with standard treatment or Sofosbuvir-Velpatasvir, Trifluoprazine, Lithium, and Trihexyphenidyl are contraindicated and can not be discontinued.
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Number of arms
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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4
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Funding
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Kermanshah University of Medical Sciences
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Inclusion age min
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
18
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Inclusion age max
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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100
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Countries
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Severe disease at enrollment
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Severity scale
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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6: Severe disease at enrollment
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Total sample size
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
80
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primary outcome
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Not need hospitalization, feels well, and is able to perform normal activities
Not need hospitalization, feels ill but is able to perform normal activities
Not need hospitalization, feels ill and isn't able to perform normal activities
Need hospitalization, feels ill and isn't able to perform normal activities
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Notes
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
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Phase
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 3
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Arms
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1580, "treatment_name": "Hydroxychloroquine+trifluoprazine", "treatment_type": "Antimalarials+antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1575, "treatment_name": "Daclatasvir+hydroxychloroquine+sofosbuvir", "treatment_type": "Antivirals+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1561, "treatment_name": "Hydroxychloroquine+lithium", "treatment_type": "Antimalarials+central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}]
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