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Trial - IRCT20201229049873N1


Column Value
Trial registration number IRCT20201229049873N1
Full text link
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Mehreban Sadeghi

Contact
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

sadeghi@skums.ac.ir

Registration date
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2021-05-23

Recruitment status
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Patients with Covid-19 with acute respiratory symptoms between the ages of 18 and 60 who test positive for the SARS-CoV-19 virus by RT-PCR or by CT scan. Lung scan (subpleural lung involvement, bilateral circumference, and more than one area). Saturated oxygen is below 88% Respiratory rate more than 24 times per minute high CRP and D-dimer level, also ferritin above 1000 Lymphopenia with a count of less than 1100

Exclusion criteria
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Patients who have a positive test for PPD, HCV, HBS Patients Have a history of neurodegenerative diseases such as multiple sclerosis Patients with heart failure, hypertension, and infections other than Covid 19 infection.

Number of arms
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Shahre-kord University of Medical Sciences

Inclusion age min
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

60

Countries
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Severe disease at enrollment

Severity scale
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

6: Severe disease at enrollment

Total sample size
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

40

primary outcome
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Changes in paraclinical outcomes Blood oxygen levels Duration of hospitalization

Notes
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 2/Phase 3

Arms
Last imported at : May 24, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 650, "treatment_name": "Infliximab", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]