| Trial registration number
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IRCT20201127049505N1 |
Full text link
Last imported at : Feb. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/53212
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First author
Last imported at : Feb. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Mohammad Badavi Zade
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Contact
Last imported at : Feb. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Drmahtab.moeinpour@yahoo.com
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Registration date
Last imported at : Feb. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2021-02-06
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Recruitment status
Last imported at : Feb. 7, 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 : Feb. 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 : Feb. 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 : Feb. 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 : Feb. 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 : Feb. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
single-center
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Study aim
Last imported at : Feb. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Treatment
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Inclusion criteria
Last imported at : Feb. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Outpatients presented with positive PCR and mild clinical signs
without pulmonary involvement on CT scan
As defined by patient with sore throat
dry cough
loss of sense of smell and taste
nausea and vomiting
O2 Sat ≥ 95
T <38
RR <24
stable pulse and blood pressure
body aches
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Exclusion criteria
Last imported at : Feb. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
y>18
Organ transplant
Severe skin history including TEN or Steven JohnsonAllergy to the studied drug
The patient has previously been treated with this drug for other reasons
Hepatitis C
Not able to take pills
Lack of awareness
Be treated with anticonvulsant drugs
Have fever and respiratory symptoms from 2 weeks ago
Be treated with immunosuppressive drugs
Be pregnant or breastfeeding
1 month ago received antiviral drugs for Covid-19
ESRD
Advance CKD
Advance liver disease
Pulmonary Advance Disease
Cardiac Advance Disease
Advance Disease Hematology
Solid tumor
Cancer of neurological diseases such as CVA
your situationG6PD deficient
Be pregnant or breastfeeding
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Number of arms
Last imported at : Feb. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2
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Funding
Last imported at : Feb. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Ahvaz University of Medical Sciences
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Inclusion age min
Last imported at : Feb. 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 : Feb. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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100
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Countries
Last imported at : Feb. 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 : Feb. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Mild disease at enrollment
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Severity scale
Last imported at : Feb. 7, 2021, 1 a.m.
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 : Feb. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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360
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primary outcome
Last imported at : Feb. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Shortness of breath
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Notes
Last imported at : Feb. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
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Phase
Last imported at : Feb. 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 : Feb. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 1219, "treatment_name": "Sofosbuvir", "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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