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Trial - IRCT20201003048904N2


Column Value
Trial registration number IRCT20201003048904N2
Full text link
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Gholamreza Khamisipour

Contact
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Research@bpums.ac.ir

Registration date
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2020-12-10

Recruitment status
Last imported at : Feb. 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : Feb. 7, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

multi-center

Study aim
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : Feb. 7, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

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.

Exclusion criteria
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

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

Number of arms
Last imported at : Feb. 7, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

4

Funding
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Boushehr University of Medical Sciences

Inclusion age min
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

20

Inclusion age max
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Moderate/severe disease at enrollment

Severity scale
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

200

primary outcome
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

The blood oxygen saturation percentage is examined as an index of oxygenation status.

Notes
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : Dec. 11, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Not reported

Arms
Last imported at : Feb. 7, 2022, 2:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"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"}]