COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04632537

Thomas G Oliver

Marianne Spevak, dutchabong.shaw.ctr@usuhs.edu (PI email not reported)

2020-11-17

Withdrawn

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: - physicians, physician assistants, nurse practitioners, nurses, medics, respiratory therapists and other hcws who are likely to care for patients with covid-19 illness - eligible for care in dod facilities (deers eligible)* - 18-64 years old - willingness to permit review of medical records - women of childbearing potential must be willing to use an effective form of birth control for 30 days post vaccination

- previously (medical history) or currently infected or ill with covid-19 - previous tb disease - fever (>38 c) within the past 24 hours - currently pregnant or breastfeeding or planning on becoming pregnant within 30 days of enrollment - current serious underlying medical conditions including: diabetes mellitus, chronic kidney disease, or any other immunocompromising condition: - known infection by human immunodeficiency virus (hiv) - history of solid organ or bone marrow transplantation - currently under chemotherapy - currently on any anti-cytokine therapy - history of immunodeficiency (including history of anti b cell therapy) - currently taking immunosuppressive drugs - treatment with oral or intravenous steroids, defined as daily doses of 10mg prednisone or equivalent for longer than 3 months - active solid or non-solid malignancy or lymphoma within the past two years - suspicion of active viral or bacterial infection - living with someone hiv+, who is immunocompromised, or is taking an immunosuppressive drug - known allergy to (components of) the bcg vaccine or a serious reaction to prior bcg administration - plan to terminate their employment at the participating health care facility or change duty stations within the next three months - not in possession of a smartphone - current participation in a covid-19 interventional trial

2

Henry M. Jackson Foundation for the Advancement of Military Medicine

18

64

None

Health workers

N/A

0

Incidence of symptomatic rt-PCR-confirmed SARS-CoV-2 infection

None

Phase 3

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