Reducing health care workers absenteeism in Coronavirus 2019 pandemic nu enhancement of the immune system through vaccination with Bacillus Calmette-Guéri

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: EUCTR2020-000919-69-NL
• Lead Sponsor: niversity Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-17
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet the following criteria:
•Adult (=18 years)
•Male or female
•Hospital personnel (expected to) taking care for patients with SARS-CoV-2 infection
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 1000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Known allergy to (components of) the BCG vaccine or serious adverse events to prior BCG administration
•Known active or latent Mycobacterium tuberculosis or with another mycobacterial species. A history with- or a suspicion of M. tuberculosis infection.
•Fever (>38 C) within the past 24 hours
•Pregnancy
•Suspicion of active viral or bacterial infection
•Vaccination in the past 4 weeks or expected vaccination during the study period, independent of the type of vaccination.
•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 anti-cytokine therapies. i) 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
•Direct involvement in the design or the execution of the BCG-CORONA study
•Expected absence from work of =4 of the following 12 weeks due to any reason (holidays, maternity leave, retirement, planned surgery etc)
•Employed to the hospital < 22 hours per week
•Not in possession of a smartphone

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To reduce absenteeism among HCW with direct patient contacts during the epidemic phase of SARS-CoV-2.;Secondary Objective: To reduce hospital admission, ICU admission or death in HCW with direct patient contacts during the epidemic phase of SARS-CoV-2.;Primary end point(s): Number of days of unplanned absenteeism for any reason ;Timepoint(s) of evaluation of this end point: Between day 0 up to day 180 after inclusion