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Trial - ISRCTN47802196


Column Value
Trial registration number ISRCTN47802196
Full text link
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Dr Susan Martins Pereira

Contact
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

susanmp@gmail.com

Registration date
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2021-05-19

Recruitment status
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Recruiting

Study design
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Cluster

Masking
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Prevention

Inclusion criteria
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Participants from the BCGREVAC trial (1996 - 1998) who were diagnosed or died from COVID-19 from January 27, 2020, onwards.

Exclusion criteria
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Does not meet inclusion criteria.

Number of arms
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

National Council for Scientific and Technological Development

Inclusion age min
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

100

Countries
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Brazil

Type of patients
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Healthy volunteers

Severity scale
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

N/A

Total sample size
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

200805

primary outcome
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Measured using patient records at a single timepoint: 1. COVID-19 incidence 2. COVID-19 severity (COVID-19 severity classification: 1) SpO2 < 95% on room air at sea level; 2) vigorous breathing effort; 3) cyanosis; 4) severe pneumonia; 5) Severe Acute Respiratory Syndrome (SARS); 6) sepsis; 7) septic shock)

Notes
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Arms
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "revaccinated group (neonatal BCG and a second dose of BCG vaccination at school age)", "treatment_id": 186, "treatment_name": "Bcg vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "vaccinated group (neonatal BCG vaccination)", "treatment_id": 186, "treatment_name": "Bcg vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]