COVID-19 SERIOUS RESPIRATORY TRACT INFECTION
Conditions
Interventions
Participants will be randomized between intracutaneous administration of BCG
vaccine (Danish strain 1331) or placebo (0.1ml 0.9% NaCl) in a 1:1 ratio
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The trial has an adaptive primary endpoint. Based on accrual of the two endpoints , the primary endpoint will be either a) clinically relevant respiratory tract infections requiring medical intervention, potentially including COVID-19, or b) laboratory-confirmed and/or physician-diagnosed COVID-19.The other will be declared secondary endpoint | — |
Secondary
| Measure | Time frame |
|---|---|
| SARS-CoV-2 infection (including asymptomatic infections), influenza infection, Acute Respiratory Infection, ARI-related hospital admission, COVID-19 related hospital admission, pneumonia, mental, physical and social functioning, serious adverse events and adverse events. | — |
Countries
Netherlands
Outcome results
None listed