Protection Covid infection by patients with chronic diseases or major surgery MedDRA version: 20.0 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: BCG SSI, Denmark
Pharmaceutical Form:
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intradermal use
Sponsors
UMCU Utrecht
UMCU Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age =60 years • Having a chronic somatic disease* or having undergone major surgery** • Meeting at least one of the following criteria: a) 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. b) Visiting a medical outpatient clinic c) Attending the thrombosis care service * Chronic somatic diseases do not include risk factors such as hypertension or obesity ** Major surgery is any invasive operative procedure in which a more extensive resection is performed, e.g. a body cavity is entered, organs are removed, or normal anatomy is altered. In general, if a mesenchymal barrier is opened (pleural cavity, peritoneum, meninges), the surgery is considered major. 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 5500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5500
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. This exclusion category comprises: a) known infection by the human immunodeficiency virus (HIV-1); b) neutropenic with less than 500 neutrophils/mm3; c) solid organ transplantation; d) bone marrow transplantation; e) hematological malignancy; f) chemo-, radio- or immunotherapy for solid organ malignancy in the past 6 months; g) primary immunodeficiency; h) severe lymphopenia with less than 400 lymphocytes/mm3; i) treatment with any immunosuppressant drugs such as anti-cytokine therapies, and treatment with oral or intravenous steroids defined as daily doses of >10 mg/day or a cumulative dose of >700 mg prednisone or equivalent for other corticosteroids in the three months prior to enrolment, or probable use of oral or intravenous steroids in the following four weeks; j) receiving chronic renal replacement therapy. • Known history of a positive Mantoux or active TB; prior BCG vaccination or a positive Mantoux test after BCG vaccination without confirmation of TB are NOT an exclusion criterion. • Born in a country with high incidence of TB (see supplement B) • Active participation in another research study that involves BCG administration • History of documented COVID-19 (self-reported by the participant: either confirmed by a microbiological test or with clinical diagnosis during hospitalization) • Not able to perform the study procedures as judged by the attending physician • Legally incapacitated or unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: To determine in vulnerable elderly the effect of BCG vaccination on • the incidence of COVID-19, or • the incidence of clinically relevant RTI (potentially including COVID-19) ;Secondary Objective: Secondary Objectives: To determine the safety of BCG vaccination in vulnerable elderly. To determine the effect of BCG vaccination in vulnerable elderly on: • The cumulative incidence of all SARS-CoV-2 infections • The cumulative incidence of asymptomatic, mild/moderate, and severe (requiring hospitalization) SARS-CoV-2 infections • The cumulative incidence of laboratory-confirmed influenza infection • The incidence of all RTI • The incidence of medically attended RTI • The incidence of RTI related hospital admission • The incidence of pneumonia • Mental, physical and social functioning • All cause 6-month mortality ;Primary end point(s): The trial has an adaptive primary endpoint. Based on accrual of the two endpoints, the primary endpoint will be either (a) COVID-19 or (b) clinically relevant respiratory tract infection (RTI) requiring medical intervention, potentially including COVID-19 episodes. The other will be declared secondary endpoint. Other secondary endpoints include: all SARS-CoV-2 infections (including asymptomatic infections), influenza infection, RTI (all infections regardless of medical intervention), RTI-related hospital admission, COVID-19 related hospital admission, pneumonia, mental, physical and social functioning, serious adverse events and adverse events, and death.;Timepoint(s) of evaluation of this end point: The trial has an adaptive primary endpoint. Based on accrual of the two endpoints, the primary endpoint will be either (a) COVID-19 or (b) clinically relevant respiratory tract infection (RTI) requiring medical intervention, potentially including COVID-19 episodes | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The other will be declared secondary endpoint. Other secondary endpoints include: all SARS-CoV-2 infections (including asymptomatic infections), influenza infection, RTI (all infections regardless of medical intervention), RTI-related hospital admission, COVID-19 related hospital admission, pneumonia, mental, physical and social functioning, serious adverse events and adverse events, and death.;Timepoint(s) of evaluation of this end point: Dynamic, which comes first | — |
Countries
Netherlands
Outcome results
None listed