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| Column | Value |
|---|---|
| Trial registration number | IRCT20210620051639N3 |
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Full text link
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
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First author
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
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Contact
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
jafar.salimian@gmail.com |
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Registration date
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
2021-12-23 |
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Recruitment status
Last imported at : April 4, 2022, 8:11 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Completed |
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Study design
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
RCT |
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Allocation
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Randomized |
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Design
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Parallel |
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Masking
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Blind label |
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Center
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
multi-center |
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Study aim
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Prevention |
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Inclusion criteria
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Age 18 years and older Candidates who have received two identical doses of the available vaccine (Sinopharm, CovIran Barakat, AstraZenka) and at least 3 months (at least 90 days) have passed since the second dose The candidate is able to fully understand the provisions of the informed consent form and sign it before entering the study |
|
Exclusion criteria
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
SARS CoV 2 infection (clinically significant or rtPCR document) Approved or suspected COVID 19 in the last two months Going through home quarantine due to suspicion of having an exposure to a patient with Corona History of severe allergic reactions Chronic kidney, liver and various malignancies Acute bacterial infection in the last 7 days Known cases of immunodeficiency, HIV, or autoimmune diseases Receiving immunosuppressive drugs or corticosteroids in the last 3 months Receiving immunoglobulin or blood products during the three months prior to vaccination Pregnant or Breastfeeding women or those who plan to become pregnant during the study period |
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Number of arms
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
2 |
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Funding
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Bagheiat-allah University of Medical Sciences |
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Inclusion age min
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
18 |
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Inclusion age max
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
100 |
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Countries
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Iran |
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Type of patients
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Healthy volunteers |
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Severity scale
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
N/A |
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Total sample size
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
10300 |
|
primary outcome
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
ّThe level of specific IgG antibody against RBD protein in days 0 and 21 after booster injection based on GMI, GMT and seroconversion rate (increase at least 4 times in antibody titer) in Shahid Soleimani Clinical Trial Center (sample of 300 people). Cellular immune response to booster dose based on measurement of IL 4 and INFγ levels using ELISA method on days 0 and 21 after injection (subgroup of 90 people) Measurement of neutralizing antibody level by neutralization test method Virus (subgroup of 90 people) |
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Notes
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
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Phase
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Phase 3 |
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Arms
Last imported at : Dec. 24, 2021, 6 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
[{"arm_notes": "1;80 \u03bcg;who have received two identical doses of the available vaccine (Sinopharm, CovIran Barakat, AstraZenka) and at least 3 months (at least 90 days) have passed since the second dose", "treatment_id": 1920, "treatment_name": "Noora", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |