BACILLUS CALMETTE-GUÉRIN VACCINATION TO PREVENT SERIOUS RESPIRATORY TRACT INFECTION AND COVID-19 IN VULNERABLE ELDERLY -* AN ADAPTIVE RANDOMIZED CONTROLLED TRIA

Completed

• Conditions: COVID-19; SERIOUS RESPIRATORY TRACT INFECTION; 10047438

• Registration Number: NL-OMON49683
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-07-22
• Results First Posted: 2022-07-14
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6112

Inclusion Criteria

criteria:
* Age *60 years
* Meeting at least one of the following criteria:
a) Having a chronic somatic disease*
b) Having undergone major surgery**
c) Planned to be discharged from the hospital or discharged from the hospital
less than 6 weeks ago; a hospital admission is defined as an overnight stay.
Departments of interest are those that in the opinion of the principle
investigator admit mostly vulnerable elderly and include but are not limited
to: cardiology, pulmonology, internal medicine, neurology.
d) Attending the thrombosis care service
* Written informed consent

Exclusion Criteria

* Fever (>38 ºC) within the past 24 hours
* Suspicion of current active viral or bacterial infection; the requirement to
finish an antibiotic course upon discharge is not an exclusion criterion when
the infection is controlled in the opinion of the attending physician
* Vaccination with live vaccine in the past four weeks or planned vaccination
with live vaccine during the next four weeks
* Severely immunocompromised participants
* Known history of a positive Mantoux or active TB enHistory of documented
COVID-19

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The trial has an adaptive primary endpoint. Based on accrual of the two<br /><br>endpoints , the primary endpoint will be either a) clinically relevant<br /><br>respiratory tract infections requiring medical intervention, potentially<br /><br>including COVID-19, or b) laboratory-confirmed and/or physician-diagnosed<br /><br>COVID-19.The other will be declared secondary endpoint</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>SARS-CoV-2 infection (including asymptomatic infections), influenza infection,<br /><br>Acute Respiratory Infection, ARI-related hospital admission, COVID-19 related<br /><br>hospital admission, pneumonia, mental, physical and social functioning, serious<br /><br>adverse events and adverse events.</p><br>