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Trial - IRCT20200731048257N1


Column Value
Trial registration number IRCT20200731048257N1
Full text link
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Dr. Reza Mohtashami

Contact
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

reza_mohtashami1979@yahoo.com

Registration date
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

2020-11-08

Recruitment status
Last imported at : March 5, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

multi-center

Study aim
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

informed consent to participate in the study Patients 18 to 75 years of age with COVID-19 who have been diagnosed with PCR Strong clinical suspicion of covid 19 with positive findings in CT Scan Shortness of breath

Exclusion criteria
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Patients with HIV Patients with cancer undergoing chemotherapy Patients receiving Immune Mediators Patients need hospitalization in the intensive care unit Patients with uncontrolled heart, kidney or liver failure Pregnant or lactating women Intolerance to the drugs used in this study (symptoms such as diarrhea, nausea, vomiting and respiratory problems)

Number of arms
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Bagheiat-allah University of Medical Sciences

Inclusion age min
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

75

Countries
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Moderate/severe disease at enrollment

Severity scale
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

224

primary outcome
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Dyspnea

Notes
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 3

Arms
Last imported at : Nov. 9, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 985, "treatment_name": "Phr160", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]