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| Column | Value |
|---|---|
| Trial registration number | NCT04988048 |
|
Full text link
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
mpasinovich@msal.gov.ar |
|
Registration date
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
2021-08-03 |
|
Recruitment status
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
Recruiting |
|
Study design
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - 18 years of age or older, vaccinated with 1 dose of sputnik v, astrazeneca or sinopharm vaccine up to 60 days prior to enrollment (according to the platform of the vaccine received as the first dose) or not vaccinated for the mrna-1273 / mrna-1273 arm - with and without identified risk factors for covid-19 - signature of the informed consent - remain in the jurisdiction where your study began until the end of it - be able to understand and sign the informed consent |
|
Exclusion criteria
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
- patients with immunocompromise due to underlying disease or immunosuppressive treatment - pregnant and breastfeeding people - being registered in the national health surveillance system for having suffered covid-19 (symptomatic or asymptomatic) or having a positive igg result in nucleocapsid elisa in the sample taken on "day 0" for people who had received sputnik-v or astrazeneca as the first dose - having had a severe allergic reaction (anaphylaxis) to any vaccine |
|
Number of arms
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
14 |
|
Funding
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
Ministry of Public Health, Argentina |
|
Inclusion age min
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
Argentina |
|
Type of patients
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
|
Severity scale
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
1760 |
|
primary outcome
Last imported at : Aug. 10, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
Antibody against Spike protein measurement by ELISA test;Incidence of adverse events by measurement of the number of reactions after vaccination |
|
Notes
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Aug. 4, 2021, 2 p.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : Oct. 1, 2021, 9 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Heterologous: Gam-COVID-Vac C1/ ChAdOx1 nCoV-19", "treatment_id": 1522, "treatment_name": "Chadox1 ncov-19+gam-covid-vac", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Heterologous: ChAdOx1 nCoV-19 / Gam-COVID-Vac C1", "treatment_id": 1522, "treatment_name": "Chadox1 ncov-19+gam-covid-vac", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Heterologous: Gam-COVID-Vac C1/ BBIBP-CorV", "treatment_id": 1521, "treatment_name": "Bbibp-corv+gam-covid-vac", "treatment_type": "Inactivated virus+non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Heterologous: BBIBP-CorV / Gam-COVID-Vac C1", "treatment_id": 1521, "treatment_name": "Bbibp-corv+gam-covid-vac", "treatment_type": "Inactivated virus+non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Heterologous: ChAdOx1 nCoV-19 / BBIBP-CorV", "treatment_id": 2104, "treatment_name": "Bbibp-corv+chadox1 ncov-19", "treatment_type": "Inactivated virus+non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Heterologous: BBIBP-CorV / ChAdOx1 nCoV-19", "treatment_id": 2104, "treatment_name": "Bbibp-corv+chadox1 ncov-19", "treatment_type": "Inactivated virus+non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Heterologous: Gam-COVID-Vac C1/ mRNA-1273", "treatment_id": 2308, "treatment_name": "Gam-covid-vac+mrna-1273", "treatment_type": "Non replicating viral vector+rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Heterologous: ChAdOx1 nCoV-19 / mRNA-1273", "treatment_id": 1986, "treatment_name": "Chadox1 ncov-19+mrna-1273", "treatment_type": "Non replicating viral vector+rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Heterologous BBIBP-CorV / mRNA-1273", "treatment_id": 2309, "treatment_name": "Bbibp-corv+mrna-1273", "treatment_type": "Inactivated virus+rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Homologous: Gam-COVID-Vac C1/ Gam-COVID-Vac C2", "treatment_id": 532, "treatment_name": "Gam-covid-vac", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Homologous: ChAdOx1 nCoV-19 / ChAdOx1 nCoV-19", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Homologous: BBIBP-CorV / BBIBP-CorV", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Homologous: mRNA-1273 / mRNA-1273", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Homologous: Gam-COVID-Vac C1/ Gam-COVID-Vac C1", "treatment_id": 532, "treatment_name": "Gam-covid-vac", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}] |