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| Column | Value |
|---|---|
| Trial registration number | NCT04962906 |
|
Full text link
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
danielferrante@buenosaires.gob.ar |
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Registration date
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
2021-07-15 |
|
Recruitment status
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - persons who have received a dose of gam-covid-vac more than 30 days and less than 90 days ago. - age between 21 and 65 years. - both genders. - who have voluntarily agreed to participate in the clinical trial and have provided informed consent. |
|
Exclusion criteria
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
- known history of covid in the 6 months prior to study inclusion. - known or suspected immunocompromised status by the study investigator for any cause. - use of oral or parenteral corticosteroids in the last 30 days. - known history of allergy to any vaccine. - history of anaphylaxis. - pregnant or lactating women. - known history of autoimmune diseases. - persons under treatment for any neoplastic disease within the last 6 months. - any serious illness or condition at the discretion of the study investigator (including but not limited to the presence of chronic obstructive pulmonary disease, heart failure, poorly controlled hypertension, poorly controlled diabetes, renal failure). - planned medical procedures within two months of randomisation. - previous vaccination within the last 30 days with any vaccine. - known participation in an ongoing clinical trial. - ongoing acute illness. - fever (≥37.8 c) at the time of randomisation. |
|
Number of arms
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
Ministerio de Salud de Ciudad Autónoma de Buenos Aires |
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Inclusion age min
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
21 |
|
Inclusion age max
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
65 |
|
Countries
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
Argentina |
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Type of patients
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
192 |
|
primary outcome
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
ELISA assessment of IgG anti Spike (UI/ml);Serious adverse events Adverse events of special interest |
|
Notes
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Heterologous vaccine scheme;1+1;Gam-COVID-Vac first and ChAdOx1 nCoV-19 second;Days0-21", "treatment_id": 1522, "treatment_name": "Chadox1 ncov-19+gam-covid-vac", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Heterologous vaccine scheme;1+1;Gam-COVID-Vac first and BBIBP-CorV second;Days0-21", "treatment_id": 1521, "treatment_name": "Bbibp-corv+gam-covid-vac", "treatment_type": "Inactivated virus+non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Homologous vaccine scheme;2;Days0-21", "treatment_id": 532, "treatment_name": "Gam-covid-vac", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}] |