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Trial - IRCT20220509054793N1


Column Value
Trial registration number IRCT20220509054793N1
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Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Mohsen Tafaghodi

Contact
Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

vcresearch@mums.ac.ir

Registration date
Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2022-06-02

Recruitment status
Last imported at : June 22, 2023, 4 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

multi-center

Study aim
Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Patients with COVID-19 infection base on clinical manifestations, chest CT scan and PCR test results Age over 18 years The oxygen saturation of patient is 85 percent or greater at rest

Exclusion criteria
Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

having chronic lung disease Pregnant women Having autoimmune disease History of allergy to the seaweed or its derivatives History of bronchospasm after using of N-acetylcysteine Having chronic liver disease History of phenylketonuria Having bleeding (Massive hemoptysis, gastrointestinal bleeding, epistaxis, purpura, ecchymosis) Neutrophil count of less than 500 mmc A platelet count of less than 2000 mmc Having acute hepatitis

Number of arms
Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Mashhad University of Medical Sciences

Inclusion age min
Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Mild/moderate disease at enrollment

Severity scale
Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

60

primary outcome
Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

The duration of hospitalization Improvement rate of clinical symptoms such as dyspnea and fever Possibility of hospitalization in ICU Mortality rate

Notes
Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 1/Phase 2

Arms
Last imported at : June 2, 2022, 1:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 2520, "treatment_name": "Arthrospira+n-acetylcysteine", "treatment_type": "Vitamins and dietary supplements+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"}]