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Trial - IRCT20181030041504N1


Column Value
Trial registration number IRCT20181030041504N1
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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.Mahood reza Masoudi

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

ssm@sirums.ac.ir

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

2020-11-08

Recruitment status
Last imported at : Nov. 9, 2020, midnight
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)

single-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)

COVID-19 virus infection by RT-PCR in non-hospitalization and hospitalization patients G6PD sufficient in non-hospitalization and hospitalization patients Lack of clinical response to routine outpatient treatment in non-hospitalization and hospitalization patients Clinical symptoms (fever, cough, myalgia, shortness of breath, digestive problems) in non-hospitalization and hospitalization patients Age over 12 years in non-hospitalization and hospitalization patients Patient satisfaction in non-hospitalization and hospitalization patients Lymphocytes less than 15%, respiratory distress, lung involvement on CT scan, oxygen level less than 93%, unstable vital signs, severe gastrointestinal symptoms and oral intolerance, underlying disease Except for exclusion cases hospitalization patients

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

Allergy to oral supplements and high doses of vitamin C Reluctance to continue participating in the trial for any reason Patients admitted to the intensive care unit (ICU) (patients who have been admitted to the ICU since admission) Pregnant and lactating lady Patients with seizures Dialysis patients

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)

Sirjan Faculty of Medical Science

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

12

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

100

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)

No restriction on type of patients

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

0: No restriction on type of patients

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

100

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

LDH CBC diff Na/K/Ca CRP ESR1 Weakness and nausea Lung involvement

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": 2205, "treatment_name": "Artemisinin+hesperidin+n-acetylcysteine+noscapine+vitamin c", "treatment_type": "Antimalarials+cardiovascular agents+respiratory agents+central nervous system agents+vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]