| Trial registration number
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NCT04641858 |
Full text link
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04641858
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First author
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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Christine Stabell Benn, Professor
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Contact
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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cbenn@health.sdu.dk
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Registration date
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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2020-11-24
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Recruitment status
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Adaptive
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Masking
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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multi-center
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Study aim
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Prevention
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Inclusion criteria
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- health care worker (physician, nurse, or other) based at one of the research
hospitals.
- age ≥18 years
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Exclusion criteria
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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- known allergy to (components of) bcg or serious adverse events to prior bcg
administration;
- known previous, active or latent infection with mycobacterium tuberculosis or other
mycobacterial species
- fever (>38 c) within past 24 hours;
- previous confirmed covid-19 (positive test - pcr or antibody);
- suspicion of active viral or bacterial infection
- severely immunocompromised subjects
- self-reported hiv infection
- self-reported pregnancy;
- active solid or non-solid malignancy or lymphoma within the prior two years;
- contraindications for live attenuated vaccine administration.
- not having a mobile phone.
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Number of arms
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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University of Southern Denmark
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Inclusion age min
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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Guinea-Bissau;Mozambique
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Type of patients
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Health workers
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Severity scale
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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N/A
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Total sample size
Last imported at : March 3, 2022, 8:30 p.m.
Source : ClinicalTrials.gov
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668
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primary outcome
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Days of unplanned absenteeism due to illness
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Notes
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov
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Phase 4
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Arms
Last imported at : Nov. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "1", "treatment_id": 186, "treatment_name": "Bcg vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "1", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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