Trial registration number
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IRCT20200324046852N1 |
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/46706
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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. Mojtaba Farjaam
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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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farjam.md@gmail.com
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Registration date
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2020-04-05
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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)
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COVID-19 positive patients with positive, PCR and chest CT scan
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Exclusion criteria
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Patients with sever respiratory problems including patients with:1. Spo2<60%2. Severe respiratory distress3. Heamodynamic instabilitty 4. Acid base disturbance 5. Severe Anemia
Patients with hepatic diseases
Patients with Nervous system diseases
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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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2
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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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Fasa 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)
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None
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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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None
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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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Moderate 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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3: Moderate 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)
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30
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primary outcome
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Chest CT-Scan response to treatment including dispersion size of Ground Glass area, bronchitis and consolidation.
Response to treatment in Lymphocytes count.
Response to treatment for COVID-19 specific PCR test
Response to treatment in O2 level and CO2 level in ABG or VBG test
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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 2/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": 1436, "treatment_name": "Budesonide+formoterol+levamisole", "treatment_type": "Corticosteroids+respiratory agents+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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