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Trial - IRCT20181208041886N3


Column Value
Trial registration number IRCT20181208041886N3
Full text link
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Seyed Amir Razavian Ardehali

Contact
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

info@abidipharma.com

Registration date
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2020-12-22

Recruitment status
Last imported at : May 22, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Every patient with diagnosis of COVID-19 Mild, moderate and severe stage of the disease

Exclusion criteria
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

No complete consent and compliace of the patient for study Follow up of the patient not be possible The age below 15 years old Rifampin and Phenobarbital consumers

Number of arms
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Abidi Pharmaceutical company

Inclusion age min
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

15

Inclusion age max
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Moderate/severe disease at enrollment

Severity scale
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

60

primary outcome
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Discontinuation of fever Decreased Respiratory Rate Decreased Cough Evaluation of blood O2 Saturation

Notes
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 3

Arms
Last imported at : Dec. 23, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 816, "treatment_name": "Montelukast", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]