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Trial - NCT04992182


Column Value
Trial registration number NCT04992182
Full text link
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

First author
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

Rafael Araos

Contact
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

2021-08-05

Recruitment status
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Aug. 6, 2021, 3 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 : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - full immunization with coronavac (2 doses; 0,28) prior to april 15, 2021 - being a resident of any of the eligible nursing homes (located in the metropolitan region of chile) - healthcare workers of one of the eligible nursing homes. - healthcare workers of hospital de urgencia asistencia publica (huap, santiago, chile)

Exclusion criteria
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

- prior history of covid-19 - not able to consent

Number of arms
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

4

Funding
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

Universidad del Desarrollo

Inclusion age min
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

Chile

Type of patients
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

534

primary outcome
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

Early humoral response;Immunogenicity

Notes
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Aug. 6, 2021, 3 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]