COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04348370

Jeffrey D Cirillo;Andrew DiNardo

jdcirillo@tamu.edu; Andrew.Dinardo@Bcm.edu

2020-04-16

Not recruiting

RCT

Randomized

Adaptive

Blind label

multi-center

Prevention

inclusion criteria: - adult (≥18 years) - male or female - hospital personnel taking care for patients with known or suspected sars-cov-2 infection and providing, on average, at least 25 hours per week of direct patient care

- known allergy to (components of) the bcg vaccine or serious adverse events to prior bcg administration - known active or latent mycobacterium tuberculosis or with another mycobacterial species. a history with- or a suspicion of m. tuberculosis infection. - fever (>38 c) within the past 24 hours - age > 75 years - pregnancy or planning pregnancy within 30 days of study enrollment - breastfeeding - suspicion of active viral or bacterial infection - any immunocompromised subjects. this exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (hiv-1); b) subjects with known neutropenic with less than 1500 neutrophils/mm3; c) subjects with solid organ transplantation; d) subjects with bone marrow transplantation; e) subjects under chemotherapy; f) subjects with primary immunodeficiency; g) known severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any anti-cytokine therapies. i) treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months - living with someone who is immunosuppressed or taking immunosuppressive drugs - previous documented infection with covid19 - active solid or non-solid malignancy or lymphoma within the prior two years - direct involvement in the design or the execution of the study - expected absence from work of ≥4 of the following 12 weeks due to any reason (holidays, maternity leave, retirement, planned surgery etc) - not in possession of a smartphone - inability to keep the vaccine site covered in the case of a draining pustule.

2

Texas A&M University

18

75

United States

Health workers

N/A

1800

Incidence of COVID 19 Infection

None

Phase 4

[{"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"}]