Investigation IN VULNERABLE ELDERLY to evaluate the reduction of respiratory infections during the coronapandemie by training of the immuunsystem through a BCG vaccinatio

Phase 1

• Conditions: Protection Covid infection by patients with chronic diseases or major surgery; MedDRA version: 20.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2020-003470-47-NL
• Lead Sponsor: MCU Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-26
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 5200

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified