Prevention of COVID-19 infection MedDRA version: 21.1 Level: LLT Classification code 10036897 Term: Prophylactic vaccination System Organ Class: 100000004865 MedDRA version: 20.0 Level: LLT Classification code 10046859 Term: Vaccination System Organ Class: 100000004865
Conditions
Interventions
Trade Name: BCG Vaccine (Freeze Dried)
Product Name: Bacillus Calmette-Guerin Vaccine
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Injection
Route of administration of the placeb
Sponsors
Hellenic Institute for the Study of Sepsis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Male or female 3. Age more than or equal to 50 years based on the precise date of birth. Female participants are allowed on the premise that they are post-menopausal. 4. History of at least one of the following: a) coronary heart disease; b) chronic obstructive pulmonary disease; c) Charlson’s comorbidity index (CCI) more than 3 5. Negative serum testing for immunoglobulin G and M against SARS-CoV-2 6. Skin tuberculin test diameter less than 10mm 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 800
Exclusion criteria
Exclusion criteria: • Deny to written informed consent • Age less than 50 years • Known infection by the Human Immunodeficiency Virus-1 (HIV-1) • Severely immunocompromised patients. This exclusion category comprises: -History of congenital immunodeficiency -History of solid organ transplantation -History of bone marrow transplantation -Intake of chemotherapy the last two months -Intake of radiotherapy the last two months -Active hemalogical or solid tumor malignancy -History of any anti-cytokine therapies -History of oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to demonstrate in a double-blind, placebo-controlled approach if vaccination of participants susceptible to COVID-19 with BCG vaccine may modulate their disease susceptibility for COVID-19. This will be validated using both clinical and immunological criteria. A sub-study will run in order to assess the mechanism of benefit from BCG vaccination on vascular endothelial function and on mononuclear blood cells.;Secondary Objective: Not applicable;Primary end point(s): The two groups of vaccination are compared for the primary endpoints which is composite. Patients who meet any of the following will be considered to meet the primary endpoint: • Positive for the respiratory questionnaire endpoint when at least one of the following combination is met either at visit 2 and/or at visit 3: -One situation definitively related to COVID-19 -All four questions of symptoms possibly related to COVID-19 answered YES -At least two questions of symptoms possibly related to COVID-19 answered YES + need for admission at the emergency department of any hospital and/or need for intake of antibiotics answered YES -At least four questions of symptoms probably related to COVID-19 answered YES one of which is “need for admission at the emergency department of any hospital and/or need for intake of antibiotics” • Positive IgG or IgM antibodies against SARS-CoV-2 ;Timepoint(s) of evaluation of this end point: 90 +/- 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Positive respiratory questionnaire endpoint (as defined above) on visit 4 • Positive respiratory questionnaire endpoint (as defined above) on visit 5 • Prevalence of IgG/IgM against SARS-CoV-2 among the total of screened participants • Itemized analysis of each of the components of the respiratory questionnaire on each study visit •The incidence of new cardiovascular events on each study visit •Differences in repeated measurements of vascular parameters (arterial hardness, central arterial pressures, reflected waves, endothelial function and carotid medial sheath thickness) in visit 3 between the two sub-study groups (placebo or BCG) •Differences in repeated measurements of vascular parameters (arterial hardness, central arterial pressures, reflected waves, endothelial function and thickness of medial carotid sheath) and cardiac ultrasound at visit 5 between the two sub-study groups (placebo or BCG) •Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups (placebo or BCG) ;Timepoint(s) of evaluation of this end point: Screening Visit 2 Visit 3 Visit 4 Visit 5 | — |
Countries
Greece
Contacts
Public ContactPresident of the Board
Hellenic Institute for the Study of Sepsis
Outcome results
None listed