COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04542330

Not reported

Not reported

2020-09-09

Completed

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: • in order to be eligible to participate in this study, a subject must meet the following criteria: ≥65 years old.

- known allergy to (components of) the bcg vaccine or serious adverse events in relation to prior bcg administration - previous mycobacterium tuberculosis (m. tuberculosis) infection or known active or latent infection with m. tuberculosis or other mycobacterial species - previous confirmed covid-19 infection - fever (>38 c) within the past 24 hours or suspicion of active viral or bacterial infection - vaccination with other live attenuated vaccine within the last 4 weeks - severely immunocompromised subjects. this exclusion category comprises: - subjects with known infection with the human immunodeficiency virus (hiv) - subjects with solid organ transplantation or bone marrow transplantation - subjects under chemotherapy - subjects with primary immunodeficiency - treatment with any anti-cytokine therapy within the last year - treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months - active solid or non-solid malignancy or lymphoma within the prior two years - subjects who do not have access to e-boks.

2

Bandim Health Project

65

110

Denmark

High risk patients

N/A

1700

Acute infection

None

Phase 3

[{"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"}]