BCG vaccination against COVID-19 infection in Hungary

Phase 1

• Conditions: Therapeutic area: Not possible to specify; healthy volunteers working in the healthcare treating patients with new type of coronavirus (SARS-CoV-2) infection

• Registration Number: EUCTR2020-001783-28-HU
• Lead Sponsor: ational Korányi Institute of Pulmonology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-29
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet the following criteria:
•Adult (>18 years)
•Healthcare worker with direct contact with COVID-19 positive patients
•Written informed consent

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 950
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Fever (>37,5 ºC) within the past 24 hours
•Suspicion of current active viral or bacterial infection
•Expected vaccination during the study period, independently of the type of vaccination.
•Severely immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) neutropenic subjects with less than 500 neutrophils/mm3; c) subjects with solid organ transplantation; d) subjects with bone marrow transplantation; e) subjects under chemotherapy; f) subjects with primary immunodeficiency; g) severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any immunosuppressant drugs such as anti-cytokine therapies, and treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months, or probable use of oral or intravenous steroids in the following four weeks
•Active solid or non-solid malignancy or lymphoma within the prior two years
•Active participation in another research study that involves BCG administration

Study & Design

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