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Trial - NCT04362124


Column Value
Trial registration number NCT04362124
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04362124

First author
Last imported at : Dec. 1, 2020, 12:40 p.m.
Source : ClinicalTrials.gov

Juan C cataño, MD.MI.ID

Contact
Last imported at : Dec. 1, 2020, 12:40 p.m.
Source : ClinicalTrials.gov

kataju@hotmail.com

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-04-24

Recruitment status
Last imported at : Dec. 1, 2020, 12:40 p.m.
Source : ClinicalTrials.gov

Withdrawn

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

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

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria - men and women - between ≥18 and ≤ 65 years old - healthcare workers (doctors, nurses and nursing assistants) from clinics and hospitals in medellín, who are directly involved in the care of patients with covid-19 - a negative test for covid-19 and being asymptomatic at baseline - are able and willing to give signed informed consent (subjects whom the investigator believes are able to understand and are willing to comply with the requirements of the protocol) exclusion criteria - have a previous diagnosis (probable or confirmed) of covid-19 - immunosuppression (pharmacological or clinical) - are taking immunosuppressive medications - pregnant or lactating women; or women of childbearing age who do not agree to take contraceptives during the month following vaccination. - have received any live or replicative vaccine one month before the time of screening. - permanent teleworking activity. - history of active tuberculosis - currently are receiving hydroxychloroquine, chloroquine, lopinavir/ritonavir, tocilizumab, or azithromycin. - known or suspected history of hypersensitivity to vaccines. - patients who do not wish to attend or who cannot keep up with the follow-up visits.

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Universidad de Antioquia

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

65

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Colombia

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Close contacts to covid patients

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Dec. 1, 2020, 12:40 p.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Primary outcome

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "1", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "1", "treatment_id": 186, "treatment_name": "Bcg vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]