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| Column | Value |
|---|---|
| Trial registration number | IRCT20201214049709N3 |
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Full text link
Last imported at : Aug. 30, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
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First author
Last imported at : Aug. 30, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
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Contact
Last imported at : Aug. 30, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
a.Eshahghi@rvsri.ac.ir |
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Registration date
Last imported at : Aug. 30, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
2021-08-29 |
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Recruitment status
Last imported at : Dec. 1, 2021, 11:30 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Completed |
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Study design
Last imported at : Aug. 30, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
RCT |
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Allocation
Last imported at : Aug. 30, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Randomized |
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Design
Last imported at : Aug. 30, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Parallel |
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Masking
Last imported at : Aug. 30, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Blind label |
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Center
Last imported at : Oct. 2, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
multi-center |
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Study aim
Last imported at : Aug. 30, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Prevention |
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Inclusion criteria
Last imported at : Oct. 2, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
18 years of age or older; Having access to internet and smart phone; No current COVID-19; No pregnancy; No plan to have children in the next 6 months and willing to use at least one effective method of contraception; Signed informed consent form. |
|
Exclusion criteria
Last imported at : Oct. 2, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Any current or new diagnosis of acute or chronic illness requiring continuous ongoing medical care Breastfeeding; History of receiving any COVID -19 vaccine; Received blood and/or any blood products and/or immunoglobulins within three months preceding the screening day; Long-term use of immunosuppressive drugs or systemic corticosteroids within the past 4 months; History of allergic diseases such as angioedema or anaphylactic reactions to any drug, vaccine or food; Recent diagnosis or treatment of cancers except basal cell carcinoma and In-situ cervical cancer History of uncontrolled serious psychiatric illnesses; History of blood disorders (dyscrasia, coagulopathy, platelet deficiency or disorder, or deficiency of blood clotting factors); History of chronic neurological diseases (including seizures and epilepsy); Current substance or alcohol abuse; Splenectomy for any reason; Close contact with a confirmed COVID-19 case within two weeks before the first vaccine dose; History of diagnosis or treatment for HIV; Chronic unstable diseases in the last 4 weeks, including hospitalization due to surgery, deterioration of one organ function, the need to add new drugs or serious dose adjustments to existing drugs. |
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Number of arms
Last imported at : Aug. 30, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
2 |
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Funding
Last imported at : Aug. 30, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Razi Vaccine and Serum Research Institute |
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Inclusion age min
Last imported at : Aug. 30, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
18 |
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Inclusion age max
Last imported at : Aug. 30, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
100 |
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Countries
Last imported at : Aug. 30, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Iran |
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Type of patients
Last imported at : Aug. 30, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Healthy volunteers |
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Severity scale
Last imported at : Aug. 30, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
N/A |
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Total sample size
Last imported at : Aug. 30, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
41128 |
|
primary outcome
Last imported at : Aug. 30, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Occurrence of any symptomatic confirmed COVID-19 disease: Number and percentage of confirmed COVID-19 disease two weeks after second vaccine dose |
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Notes
Last imported at : Aug. 30, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
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Phase
Last imported at : Aug. 30, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Phase 3 |
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Arms
Last imported at : Aug. 30, 2021, 8 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
[{"arm_notes": "21 days apart followed by a nasal spray 51 days after the first dose (day 0)", "treatment_id": 1066, "treatment_name": "Razi cov pars", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "21 days apart followed by a nasal spray 51 days after the first dose (day 0)", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}] |