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Trial - IRCT20200511047396N1


Column Value
Trial registration number IRCT20200511047396N1
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Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Dr. Haleh Hamedifar

Contact
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

cinnagen@cinnagen.com

Registration date
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2020-05-16

Recruitment status
Last imported at : Nov. 21, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Patients who have Covid-19 based on the CT-scan or RT-PCR findings Hospitalized patients Willingness to participate in the study for trial period and signing the informed consent form Age between 20-65

Exclusion criteria
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Pregnancy Breastfeeding Use of ARB/ACEi History of hypotension have no consent to participate in the study Allergic sensitivity to the interferon products Not availability of phone number or it is possible to be transferred to other hospitals Having the CKD or patients who need dialysis at the begining of the study Having any disease or condition that based on the physician judgment cannot participate in the study Participation in any other trials of Covid-19

Number of arms
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

CinnaGen company

Inclusion age min
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

20

Inclusion age max
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Mild/moderate disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

50

primary outcome
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

The primary outcome was the evaluation of 50% reduction of viral load or negative results of virus before day 7

Notes
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 3

Arms
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 671, "treatment_name": "Interferon beta 1a", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]