Trial registration number
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IRCT20201003048904N2 |
Full text link
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/52607
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First author
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Gholamreza Khamisipour
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Contact
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Research@bpums.ac.ir
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Registration date
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2020-12-10
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Recruitment status
Last imported at : Feb. 18, 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 : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Dec. 11, 2020, 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, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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multi-center
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Study aim
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Feb. 7, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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admitted patients in Bushehr's Shohadaye_Khalije_Fars hospital due to COVID19 diagnosis confirmed by Rt-PCR
age equal or more than 20
Male and female OPD patients with confirmed or probable SARS-CoV-2 infection according to WHO and CDC definitions referred to Motahari Clinic.
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Exclusion criteria
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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pregnancy
positive history of spironolactone or DPP4 inhibitor consumption
contraindications for drug intervention consumption (Plasma Acid/base, Electrolyte or Glucose abnormalities)
hypersensitivity to drugs
patient dissatisfaction
intubation and mechanical ventilation at admission onset
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Number of arms
Last imported at : Feb. 7, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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4
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Funding
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Boushehr University of Medical Sciences
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Inclusion age min
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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20
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Inclusion age max
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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100
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Countries
Last imported at : Dec. 11, 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 : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Moderate/severe disease at enrollment
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Severity scale
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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4: Moderate/severe disease at enrollment
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Total sample size
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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200
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primary outcome
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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The blood oxygen saturation percentage is examined as an index of oxygenation status.
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Notes
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Not reported
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Arms
Last imported at : Feb. 7, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 1205, "treatment_name": "Sitagliptin", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1708, "treatment_name": "Sitagliptin+spironolactone", "treatment_type": "Metabolic agents+cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1228, "treatment_name": "Spironolactone", "treatment_type": "Cardiovascular agents", "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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