| Trial registration number
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IRCT20200927048849N3 |
Full text link
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/52429
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First author
Last imported at : March 18, 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 : March 18, 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 : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-03-17
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Recruitment status
Last imported at : May 20, 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 : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
RCT
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Allocation
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : March 18, 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 : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
single-center
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Study aim
Last imported at : March 18, 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 : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Infected patients of COVID-19 based on positive Polymerase Chain Reaction test
Lack of hospitalization indication based on country protocol
O2 Saturation more than 93% on the first visit
Respiratory rate more than 24 on the first visit
Age more than 18 years old
Filling and signing of consent form
A maximum of 10 days have elapsed since the onset of disease symptoms
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Exclusion criteria
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Patients with immunodeficiency based on biography
Lactose intolerance based on biography
Uncontrollable vomiting
Using antiviral drugs
Pregnancy
Failure to fill out the consent form
Receiving immunosuppressive drugs
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Number of arms
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : March 18, 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 : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
18
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Inclusion age max
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
100
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Countries
Last imported at : March 18, 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 : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Mild disease at enrollment
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Severity scale
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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1: Mild disease at enrollment
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Total sample size
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
600
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primary outcome
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Need of Hospitalization during the next 14 days
Need to go to the emergency room during 14 days
No fever and appearance of it
No cough and appearance of it
No shortness of breath and appearance of it
No muscular pain and appearance of it
Mortality rate during 28 days after beginning of the disease
ICU need during 28 days after beginning the disease
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Notes
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
|
Phase
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 3
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Arms
Last imported at : March 18, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
[{"arm_notes": "", "treatment_id": 611, "treatment_name": "Hyperimmune milk", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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