| Trial registration number
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IRCT20200318046812N3 |
Full text link
Last imported at : Jan. 13, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/53187
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First author
Last imported at : Jan. 13, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Mostafa Ghanei
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Contact
Last imported at : Jan. 13, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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mghaneister@gmail.com
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Registration date
Last imported at : Jan. 13, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-01-12
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Recruitment status
Last imported at : Feb. 18, 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. 13, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
RCT
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Allocation
Last imported at : Jan. 13, 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. 13, 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. 13, 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. 13, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
single-center
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Study aim
Last imported at : Jan. 13, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Prevention
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Inclusion criteria
Last imported at : Jan. 13, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Confirmation of infection by PCR in a family member
Informed written consent
Living in Tehran
Number of family members between 2 and 5
Age between 18 to 63 years
No prognostic signs of Covid-19 disease two weeks before enrollment
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Exclusion criteria
Last imported at : Jan. 13, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Not participating in another clinical trial in the last three months
Do not use other supplements (containing vitamins, minerals, and probiotics)
No documented history of Covid-19 infection in healthy family members
Pregnancy / breastfeeding
Drug sensitivity to the compounds in the intervention
Temporary residence or immigration and consecutive relocation from Tehran
Use similar supplements
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Number of arms
Last imported at : Jan. 13, 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. 13, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Bagheiat-allah University of Medical Sciences
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Inclusion age min
Last imported at : Jan. 13, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
18
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Inclusion age max
Last imported at : Jan. 13, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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63
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Countries
Last imported at : Jan. 13, 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. 13, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Close contacts to covid patients
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Severity scale
Last imported at : Jan. 13, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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N/A
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Total sample size
Last imported at : Jan. 13, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
500
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primary outcome
Last imported at : Jan. 13, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
ُSُeverity of cough
ُSeverity of shortness of breath
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Notes
Last imported at : Jan. 13, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
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Phase
Last imported at : Jan. 13, 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 : Jan. 13, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
[{"arm_notes": "", "treatment_id": 1022, "treatment_name": "Probiotics", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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