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Trial - IRCT20201015049030N1


Column Value
Trial registration number IRCT20201015049030N1
Full text link
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Mohammad Ali Sahraian

Contact
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

vcr@tums.ac.ir

Registration date
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

2020-11-07

Recruitment status
Last imported at : Dec. 10, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

multi-center

Study aim
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Outpatients with Covid 19 confirmed by positive PCR test for SARS-CoV-2 or confirmed by abnormal CT scan finding (bilateral, sub pleural, peripheral ground glass opacities), With blood oxygen saturation between 90-95% Patients with severe respiratory symptoms such as cough, shortness of breath and severe shortness of breath or CRP above 20 or after three days of standard treatment worsened symptoms of the disease, including exacerbated fevers, aggravated weakness or aggravated shortness of breath based on the physician's clinical judgment

Exclusion criteria
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Patients with a history of underlying disease such as diabetes, malignancies, renal and heart failure, uncontrolled hypertension, and taking immunosuppressive drugs and corticosteroids Patients with other active infections Pregnant or lactating women

Number of arms
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Tehran University of Medical Sciences

Inclusion age min
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Moderate/severe disease at enrollment

Severity scale
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

200

primary outcome
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

O2 saturation Mortality rate Need for an oxygen therapy Constitutional Needs of hospitalization

Notes
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 2

Arms
Last imported at : Nov. 8, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]