Covid 19 Research using Clinical Trials (Home Page)
BCG-DenmarkWiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (3)
Correlated MeSH Terms (6)
Correlated HPO Terms (0)
|
Name (Synonyms) |
Correlation |
There is one clinical trial.
Clinical Trials
Background: The COVID-19 pandemic challenges the available hospital capacity, and this will
be augmented by absenteeism of healthcare workers (HCW). HCW are at high risk, currently HCW
constitute 20% of all the COVID-19 cases in Denmark. Strategies to prevent absenteeism of HCW
are urgently needed.
Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific
effects against other infections; significant reductions in morbidity and mortality have been
reported, and a plausible immunological mechanism has been identified.
We hypothesize that BCG vaccination can reduce HCW absenteeism during the COVID-19 pandemic.
Primary objective: To reduce absenteeism among HCW with direct patient contacts during the
COVID-19 epidemic. Secondary objective: To reduce the number of HCW that are infected with
SARS-CoV-2 during the COVID-19 epidemic and to reduce the number of hospital admissions
amongst HCW with direct patient contacts during the COVID-19 epidemic.
Study design: A multi-center randomized placebo controlled trial. Study population: 1500 HCW
with direct patient contacts; defined as nurses, physicians and other medical staff working
at emergency rooms and wards where COVID-infected patients are treated.
Intervention: Participants will be randomized 1:1 to intradermal administration of a standard
dose of BCG vaccine or placebo (saline).
Main study parameters/endpoints: Primary endpoint: Number of days of (unplanned) absenteeism
for any reason. Secondary endpoints: Number of days of (unplanned) absenteeism because of
documented COVID infection. Cumulative incidence of hospital admissions.
Risk for participants and impact: Based on previous experience and randomized controlled
trials in adult and elderly individuals, the risks of BCG vaccination are considered low. The
objective of this trial is to evaluate the potential beneficial effects of BCG vaccination
through a lower work absenteeism rate of HCW and/or a mitigated clinical course of COVID
infection.
NCT04373291 COVID-19 Non-specific Effects of Vaccines Morbidity Absenteeism Heterologous Immunity Biological: BCG-Denmark Biological: Saline
Primary Outcomes
Measure: Number of days of unplanned absenteeism for any reason Time: 6 months
Secondary Outcomes
Measure: The cumulative incidence of documented COVID Time: 6 months
Measure: The cumulative incidence of hospital admission for any reason Time: 6 months
Measure: The number of days of unplanned absenteeism, because of documented COVID Time: 6 months
Measure: The number of days of absenteeism, because of imposed quarantine as a result of exposure to SARS-CoV-2 Time: 6 months
Measure: The number of days of absenteeism, because of imposed quarantine as a result of having acute respiratory symptoms, fever or documented SARS- CoV-2 infection Time: 6 months
Measure: The number of days of unplanned absenteeism because of self-reported acute respiratory symptoms Time: 6 months
Measure: The number of days of self-reported fever (≥38 °C) Time: 6 months
Measure: The number of days of self-reported acute respiratory symptoms Time: 6 months
Measure: The cumulative incidence of self-reported acute respiratory symptoms Time: 6 months
Measure: The cumulative incidence of death for any reason Time: 6 months
Measure: The cumulative incidence of death due to documented COVID Time: 6 months
Measure: The cumulative incidence of Intensive Care Admission for any reason Time: 6 months
Measure: The cumulative incidence of Intensive Care Admission due to documented COVID Time: 6 months
Measure: The cumulative incidence of Hospital Admission due to documented COVID Time: 6 months
No related HPO nodes (Using clinical trials)