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Trial - IRCT20210223050466N1


Column Value
Trial registration number IRCT20210223050466N1
Full text link
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Zahra Habibi dastenaei

Contact
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

habibi.z@skums.ac.ir

Registration date
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2021-03-27

Recruitment status
Last imported at : May 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Patient with COVID-19 Under 80 y/o age With positive RT-PCR test With bilateral lung parenchyma infiltration Blood oxygen saturation <93% Did not take any medication or hospitalization for COVID-19 Taking any Corticosteroid They have tendency to participate in this study

Exclusion criteria
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Patient leave hospital before discharge Patient who expire in first 24 hour after admission Patient with myocardial infarction during hospitalization Patient with underlying disease who have contraindication of corticosteroid such as acute hepatitis, fungal infection All patient who disagree to continue the study

Number of arms
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Shahre-kord University of Medical Sciences

Inclusion age min
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

15

Inclusion age max
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

80

Countries
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Severe/critical disease at enrollment

Severity scale
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

7: Severe/critical disease at enrollment

Total sample size
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

140

primary outcome
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blood oxygen saturation Duration of hospitalization Duration between onset of symptom to start of corticosteroid

Notes
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 2/Phase 3

Arms
Last imported at : March 28, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 798, "treatment_name": "Methylprednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}]