| Trial registration number
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IRCT20220407054446N1 |
Full text link
Last imported at : May 22, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/62845
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First author
Last imported at : May 22, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Dr. Elham Barahimi
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Contact
Last imported at : May 22, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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research@hums.ac.ir
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Registration date
Last imported at : May 22, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2022-05-22
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Recruitment status
Last imported at : April 19, 2023, 4 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : May 22, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : May 22, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : May 22, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Parallel
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Masking
Last imported at : May 22, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Open label
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Center
Last imported at : May 22, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
single-center
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Study aim
Last imported at : May 22, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Treatment
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Inclusion criteria
Last imported at : May 22, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Age 18 years or older
Conscious and voluntary satisfaction
Definitive diagnosis of COVID-19 disease by PCR test
Hospitalized with early sign of moderate disease
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Exclusion criteria
Last imported at : May 22, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Multiple organ failure
Severe ARDS
Septic shock
Acute kidney injury (which GFR is <15)
Drug allergy / Sensitivity to drugs with sulfuric structure / Intolerance to co-trimoxazole
Women during pregnancy and lactation, taking other antiviral drugs, tocilizumab or plasma therapy
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Number of arms
Last imported at : May 22, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : May 22, 2022, 10 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 : May 22, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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18
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Inclusion age max
Last imported at : May 22, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
100
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Countries
Last imported at : May 22, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : May 22, 2022, 10 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 : May 22, 2022, 10 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 : May 22, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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60
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primary outcome
Last imported at : May 22, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Reduction of viral load at the end of the study
Improvement of clinical symptoms during the intervention period (improvement of clinical symptoms as continuous improvement (more than 72 hours)
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Notes
Last imported at : May 22, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
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Phase
Last imported at : May 22, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Not reported
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Arms
Last imported at : May 22, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 331, "treatment_name": "Cotrimoxazole", "treatment_type": "Antibiotics", "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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