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Trial - IRCT20200921048786N1


Column Value
Trial registration number IRCT20200921048786N1
Full text link
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Leila Masoudi Yekta

Contact
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

masoudiyekta@yahoo.com

Registration date
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

2020-11-11

Recruitment status
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Open label

Center
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Individuals over 18 years of age whose covid-19 disease has been confirmed by PCR test (PCR specification of the test from the Iranian manufacturer - Pishtaz Teb and performed by molecular method) and clinically severely ill o2sat below 90% despite receiving oxygen Severe bilateral pulmonary involvement Satisfaction to participate in the study Failure to receive any medication other than the standard protocol approved by the National Corona Therapy

Exclusion criteria
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

History of drug allergies to similar compounds Pregnancy and lactation Infection with other microbial or viral infections History of heart disease

Number of arms
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Dezfoul University of Medical Sciences

Inclusion age min
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Severe disease at enrollment

Severity scale
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

6: Severe disease at enrollment

Total sample size
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

82

primary outcome
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Clinical efficacy according to clinical response based on blood oxygen saturation LDH levels Duration of hospitalization Mortality rate Changes in liver enzymes Clinical efficacy of treatment regimen based on changes in respiratory rate

Notes
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 3

Arms
Last imported at : Nov. 12, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 672, "treatment_name": "Interferon beta 1b", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]