Status:
COMPLETED
Bacillus Calmette-guérin Vaccination to Prevent COVID-19
Lead Sponsor:
Hellenic Institute for the Study of Sepsis
Conditions:
COVID-19
Virus Diseases
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
Based on findings of the interim analysis of the ACTIVATE study showing 53% decrease of the incidence of all new infections with BCG vaccination, a new trial is designed aiming to validate if BCG can ...
Detailed Description
Infection by the novel SARS-CoV-2 virus (also known as COVID-19) has tremendous social impact. Most of Western societies are at major or part lock-down whatever brings unpredictable financial and soci...
Eligibility Criteria
Inclusion
- Written informed consent
- Male or female
- 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.
- History of at least one of the following:
- coronary heart disease;
- chronic obstructive pulmonary disease;
- Charlson's comorbidity index (CCI) more than 3
- Negative serum testing for immunoglobulin G and M against SARS-CoV-2
- Skin tuberculin test diameter less than 10mm
Exclusion
- 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 hematological 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
Key Trial Info
Start Date :
May 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2021
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT04414267
Start Date
May 26 2020
End Date
May 7 2021
Last Update
May 11 2021
Active Locations (15)
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1
General Hospital of Argolida - Nafplion Unit
Nafplion, Argos, Greece, 21100
2
2nd Department of Internal Medicine, University General Hospital of Alexandroupolis
Alexandroupoli, Greece, 68100
3
Department of Therapeutics, Alexandra General Hospital
Athens, Greece, 115 28
4
1st Department of Internal Medicine, General Hospital of Athens G. GENNIMATAS
Athens, Greece, 11527