COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04537663

Marc Bonten, MD, PhD

Not reported

2020-09-03

Completed

RCT

Randomized

Adaptive

Blind label

multi-center

Prevention

inclusion criteria: age ≥60 years having a chronic disease or having undergone major surgery meeting at least one of the following criteria: planned to be discharged from the hospital or discharged from the hospital less than 6 weeks ago; a hospital admission is defined as an overnight stay. departments of interest are those that in the opinion of the principle investigator admit mostly vulnerable elderly and include but are not limited to: cardiology, pulmonology, internal medicine, neurology. visiting a medical outpatient clinic attending the thrombosis care service

fever (>38 ºc) within the past 24 hours suspicion of current active viral or bacterial infection; the requirement to finish an antibiotic course upon discharge is not an exclusion criterion when the infection is controlled in the opinion of the attending physician vaccination with live vaccine in the past four weeks or planned vaccination with live vaccine during the next four weeks severely immunocompromised participants. this exclusion category comprises: known infection by the human immunodeficiency virus (hiv-1); neutropenic with less than 500 neutrophils/mm3; solid organ transplantation; bone marrow transplantation; hematological malignancy; chemo-, radio- or immunotherapy for solid organ malignancy in the past 6 months; primary immunodeficiency; severe lymphopenia with less than 400 lymphocytes/mm3; treatment with any immunosuppressant drugs such as anti-cytokine therapies, and treatment with oral or intravenous steroids defined as daily doses of >10 mg/day or a cumulative dose of >700 mg prednisone or equivalent for other corticosteroids, or probable use of oral or intravenous steroids in the following four weeks known history of a positive mantoux or active tb; prior bcg vaccination is not an exclusion criterion. born in a country with high incidence of tb; a list of non-eligible countries will be created by the trial steering committee prior to the first enrolment. active participation in another research study that involves bcg administration history of documented covid-19 (self-reported by the participant: either confirmed by a microbiological test or with clinical diagnosis during hospitalization) not able to perform the study procedures as judged by the attending physician legally incapacitated or unwilling to provide informed consent

2

UMC Utrecht

60

100

Netherlands

High risk patients

N/A

6112

The trial has an adaptive primary endpoint. Based on predefined objective and quantitative criteria the primary endpoint will be either a clinically relevant respiratory tract infection, or COVID-19.

None

Phase 4

[{"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"}]