Reducing health care workers absenteeism in SARS-CoV-2 pandemic by enhanced trained immune responses through Bacillus Calmette-Guérin vaccination, a randomized controlled trial.

Phase 3

Completed

• Conditions: COVID-19; SARS-CoV-2; 10047438

• Registration Number: NL-OMON49761
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1500

Inclusion Criteria

* Adult (*18 years)
* Male or female
* Hospital personnel taking care for patients with SARS-CoV-2 infection

Exclusion Criteria

* 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
* 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 less than 22 hours per week
* Not in possession of a smartphone
* Vaccination in the past 4 weeks or expected vaccination during the study
period, independent of the type of vaccination.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: number of days of (unplanned) absenteeism for any reason.</p><br>