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Trial - NCT04983537


Column Value
Trial registration number NCT04983537
Full text link
Last imported at : July 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04983537

First author
Last imported at : July 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

Daniel Ferrante, MD

Contact
Last imported at : July 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

danielferrante@buenosaires.gob.ar

Registration date
Last imported at : July 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

2021-07-30

Recruitment status
Last imported at : July 4, 2023, 8 p.m.
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : July 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : July 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : July 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : July 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : July 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : July 31, 2021, 1 p.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 > 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 31, 2021, 1 p.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 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : July 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

Ministerio de Salud de Ciudad Autónoma de Buenos Aires

Inclusion age min
Last imported at : July 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

66

Inclusion age max
Last imported at : July 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : July 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

Argentina

Type of patients
Last imported at : July 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : July 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : July 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

120

primary outcome
Last imported at : July 31, 2021, 1 p.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 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : July 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : July 31, 2021, 1 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 532, "treatment_name": "Gam-covid-vac", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 1522, "treatment_name": "Chadox1 ncov-19+gam-covid-vac", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 1521, "treatment_name": "Bbibp-corv+gam-covid-vac", "treatment_type": "Inactivated virus+non replicating viral vector", "pharmacological_treatment": "Vaccine"}]