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Bacillus Calmette-guérin Vaccination to Prevent COVID-19

NCT04414267 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2021-05-11

No results posted yet for this study

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 protect against COVID-19 (Corona Virus Disease-19).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. At the same time, a sub-study will be conducted and the mechanism of benefit from BCG vaccination by assessing its effect on vascular endothelial function and mononuclear blood cells will be studied

Conditions

Interventions

BIOLOGICAL

BCG vaccine

Patients susceptible to SARS-CoV-2 infection will be vaccinated with one intradermal injection of 0.1ml of BCG vaccine

BIOLOGICAL

Placebo

Patients susceptible to SARS-CoV-2 infection will be vaccinated with one intradermal injection of 0.1ml of sodium chloride 0.9%

Sponsors & Collaborators

  • Hellenic Institute for the Study of Sepsis

    lead OTHER

Principal Investigators

  • Antonios Papadopoulos, MD, PhD · National Kapodistrian University of Athens, Medical School

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-26
Primary Completion
2021-04-28
Completion
2021-05-07

Countries

  • Greece

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04414267 on ClinicalTrials.gov