SARS-CoV-2 infection MedDRA version: 20.0 Level: HLT Classification code 10047490 Term: Virus identification and serology System Organ Class: 100000004848
Conditions
Sponsors
Radboudumc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To reduce hospital admission of elderly people during the SARS-CoV-2 outbreak.;Secondary Objective: To reduce SARS-CoV-2 related symptoms, the duraction of hospital admission or death of elderly people during the SARS-CoV-2 outbreak.;Primary end point(s): SARS-CoV-2 related hospital admission;Timepoint(s) of evaluation of this end point: Between day 0 up to 12 months after inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints will be: • the duration of hospital admission • the cumulative incidence of documented SARS-CoV-2 infection • the number of days of self-reported fever (=38 ºC) • the number of days of self-reported acute respiratory symptoms • the cumulative incidence of self-reported acute respiratory symptoms • the cumulative incidence of delirium due to SARS-CoV-2 • the cumulative incidence of pneumonia, skin infection, urinary tract infection, flu and gastro-intestinal infection • the cumulative incidence of death for any reason • the cumulative incidence of death due to documented SARS-CoV-2 infection • the cumulative incidence of hospital or Intensive Care Admission for any reason • the cumulative incidence of Intensive Care Admission due to documented SARS-CoV-2 infection ;Timepoint(s) of evaluation of this end point: Between day 0 up to month 12 after inclusion | — |
Countries
Netherlands
Contacts
Public ContactJaap ten Oever
Radboudumc
Outcome results
None listed