| Trial registration number
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IRCT20140818018842N22 |
Full text link
Last imported at : Jan. 13, 2022, 11 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/61044
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First author
Last imported at : Jan. 13, 2022, 11 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Maryam Barkhordar
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Contact
Last imported at : Jan. 13, 2022, 11 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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mbarkhordar@sina.tums.ac.ir
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Registration date
Last imported at : Jan. 13, 2022, 11 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2022-01-12
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Recruitment status
Last imported at : Oct. 24, 2022, 4 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : Jan. 13, 2022, 11 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
nonRCT
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Allocation
Last imported at : Jan. 13, 2022, 11 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Non-randomized
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Design
Last imported at : Jan. 13, 2022, 11 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Single group assignment
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Masking
Last imported at : Jan. 13, 2022, 11 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Open label
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Center
Last imported at : Jan. 13, 2022, 11 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
single-center
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Study aim
Last imported at : Jan. 13, 2022, 11 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Prevention
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Inclusion criteria
Last imported at : May 15, 2022, 7:42 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Allogeneic stem cell transplantation
successfully engraftment with full donor chimerism
Age >=18
between 3 to 12 months after Allo-HSCT
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Exclusion criteria
Last imported at : May 15, 2022, 7:42 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
grade 3,4 acute GvHD or severe extensive chronic GvHD
Patients who do not consent to vaccination after transplantation
receive more than 0.5 mg/kg/day prednisolone
positive RT-PCR test for COVID-19 during the last three months
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Number of arms
Last imported at : Jan. 13, 2022, 11 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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1
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Funding
Last imported at : Jan. 13, 2022, 11 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Tehran University of Medical Sciences
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Inclusion age min
Last imported at : Jan. 13, 2022, 11 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
18
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Inclusion age max
Last imported at : Jan. 13, 2022, 11 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
70
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Countries
Last imported at : Jan. 13, 2022, 11 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, 2022, 11 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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High risk patients
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Severity scale
Last imported at : Jan. 13, 2022, 11 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 : May 15, 2022, 7:42 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
40
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primary outcome
Last imported at : Jan. 13, 2022, 11 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
SARS-CoV-2 specific IgG (anti-S1) titer
B lymphocyte count
NK cell count
T cell count
Cumulative incidence of COVID-19
Acute graft versus host disease
Overall survival
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Notes
Last imported at : Jan. 13, 2022, 11 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
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Phase
Last imported at : Jan. 13, 2022, 11 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 2
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Arms
Last imported at : May 15, 2022, 7:42 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
[{"arm_notes": "", "treatment_id": 2438, "treatment_name": "Pastocovac", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]
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