Reducing hospital admission of elderly in Coronavirus pandemic by boosting the immune system through vaccination with bacillus Calmette-Guérin (BCG).

Phase 1

• Conditions: SARS-CoV-2 infection; MedDRA version: 20.0Level: HLTClassification code 10047490Term: Virus identification and serologySystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001591-15-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-06
• Last Update Posted: 12 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2000

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints will be:<br>•the duration of hospital admission<br>•the cumulative incidence of documented SARS-CoV-2 infection <br>•the number of days of self-reported fever (=38 ºC)<br>•the number of days of self-reported acute respiratory symptoms <br>•the cumulative incidence of self-reported acute respiratory symptoms<br>•the cumulative incidence of delirium due to SARS-CoV-2<br>•the cumulative incidence of pneumonia, skin infection, urinary tract infection, flu and gastro-intestinal infection<br>•the cumulative incidence of death for any reason<br>•the cumulative incidence of death due to documented SARS-CoV-2 infection<br>•the cumulative incidence of hospital or Intensive Care Admission for any reason<br>•the cumulative incidence of Intensive Care Admission due to documented SARS-CoV-2 infection<br>;Timepoint(s) of evaluation of this end point: Between day 0 up to month 12 after inclusion