Reducing hospital admission of elderly in SARS-CoV-2 pandemic via the induction of trained immunity by bacillus Calmette-Guérin vaccination, a randomized controlled trial. - BCG-CORONA-ELDERLY

Radboudumc0 个研究点目标入组 2,000 人开始时间: 2020年4月6日最近更新: 2021年10月12日

适应症

试验速览

暂无简介。

•In order to be eligible to participate in this study, a subject must meet the following criteria:
•Adult (= 60 years)
•Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 800
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1200

•Fever (>38 ºC) within the past 24 hours
•Suspicion of current active viral or bacterial infection
•Severely immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) neutropenic subjects with less than 500 neutrophils/mm3; c) subjects with solid organ transplantation; d) subjects with bone marrow transplantation; e) subjects under chemotherapy; f) subjects with primary immunodeficiency; g) severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any immunosuppressant drugs such as anti-cytokine therapies, and treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months, or probable use of oral or intravenous steroids in the following four weeks
•Active solid or non-solid malignancy or lymphoma within the prior two years
•Active participation in another research study that involves BCG administration

发起方