| Trial registration number
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IRCT20200927048849N2 |
Full text link
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/52537
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First author
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Rasoul Roknizadeh
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Contact
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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research.deputy@dean.ui.ac.ir
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Registration date
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-01-06
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Recruitment status
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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single-center
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Study aim
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Infected patients of COVID-19 based on positive PCR or HRCT result compatible with disease
Hospitalization of patient in hospital
With oxygen via nasal cannula
93%≤O2 Sat
Age >18years old
Filling and signing of consent form
Allowing the patient to consume food orally
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Exclusion criteria
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Patients with immunodeficiency based on biography
Patients with Lactose intolerance based on biography
Uncontrollable vomit
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Number of arms
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Isfahan university
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Inclusion age min
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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18
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Inclusion age max
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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100
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Countries
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Severe disease at enrollment
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Severity scale
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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6: Severe disease at enrollment
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Total sample size
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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40
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primary outcome
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Hospital mortality rate
Mortality rate during 28 days after the beginning of disease
Admission rate of patient in ICU (based on hospital protocols)
Days that patient needs to be hospitalized
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Notes
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
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Phase
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 2/Phase 3
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Arms
Last imported at : Jan. 7, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 611, "treatment_name": "Hyperimmune milk", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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