|drug3320||The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care: Wiki||1.00|
|drug357||BCG GROUP Wiki||1.00|
|D009080||Mucocutaneous Lymph Node Syndrome NIH||1.00|
|D001997||Bronchopulmonary Dysplasia NIH||1.00|
|D014552||Urinary Tract Infections NIH||1.00|
|D004314||Down Syndrome NIH||1.00|
|D000309||Adrenal Insufficiency NIH||1.00|
|D001289||Attention Deficit Disorder with Hyperactivity NIH||0.58|
|D020141||Hemostatic Disorders NIH||0.26|
|D001778||Blood Coagulation Disorders NIH||0.26|
|D003141||Communicable Diseases NIH||0.07|
|D045169||Severe Acute Respiratory Syndrome NIH||0.04|
|D018352||Coronavirus Infections NIH||0.04|
|HP:0000846||Adrenal insufficiency HPO||1.00|
There is one clinical trial.
Healthcare Workers (HCW) are at high risk for COVID-19. In addition to the risk of serious forms among HCW, significant absenteeism due to illness would have dramatic consequences in our ability to fight COVID-19. No coronavirus vaccine is available today and drug treatments are only at the start of clinical evaluation. Available since 1921, the bacillus Calmette and Guérin (BCG) is the most widely used vaccine in the world (> 3 billion doses administered) with an extremely low rate of adverse effects. BCG is indicated for the prevention of tuberculosis (TB), but more recent studies have shown that it also has nonspecific immune properties which may be interesting in the current COVID-19 epidemic. Data in mice and in humans have demonstrated protection conferred by BCG against viral respiratory infections such as influenza. In countries with high endemic TB, BCG decreases the incidence of acute respiratory infections by up to 80%, neonatal BCG vaccination has been shown to greatly reduce the risk of sepsis and of hospitalization of children for reasons other than TB. A recent study conducted in South Africa showed that re-vaccination with BCG in adults reduced the incidence of respiratory infections by 70% compared to unvaccinated controls. Beyond respiratory infections, BCG has also shown protective effects against inflammatory diseases. These non-specific beneficial effects are likely linked to the induction of "trained innate immunity", implying epigenetic and metabolic re-programming of innate immune cells. It is therefore possible that revaccination with BCG could significantly reduce the incidence and severity of COVID-19. Very recent ecological observations indeed suggest an inverse correlation between BCG vaccination coverage and the morbidity and mortality of COVID-19. In this context several trials began in Europe and Australia to evaluate the efficacy of BCG vaccination in populations at risk of exposure (HCW) or severe disease (elderly). This study is aligned with studies carried out in Australia, The Netherlands and Spain. In contrast to these latter studies, virtually all French study participants have been vaccinated in their childhood, since BCG vaccination was mandatory in France in neonates until 2007, and in HCW until recently. Therefore, the French study will be in a unique situation to evaluate the effect of re-vaccination with BCG in the context of BCG priming decades before revaccination.
Description: Documented COVID-19, i.e. symptomatic COVID-19 confirmed by either positive nasopharyngeal tests for SARS CoV2 and/or by thoracic tomodensitometry compatible with the diagnosis. and/or SARS CoV2 seroconversionMeasure: Incidence of documented COVID-19 among health care workers exposed to SARS CoV2 and vaccinated with BCG compared to placebo. Time: during the study period of 6 months
Description: Participants having developed a severe form of COVID-19, as defined by the necessity for hospitalization in ICU and O2 or artificial ventilation, or extracorporeal membrane oxygenation, or deathMeasure: Numbers of COVID-19 patients requiring hospitalization in ICU and O2, artificial ventilation or extracorporal membrane oxygenation, or deaths in BCG-vaccinated health care workers compared to placebo Time: during the study period of 6 months.
Description: Participants with seroconversion during the study, without symptoms related to COVID-19Measure: Incidence of asymptomatic SARS CoV2 seropositive subjects among BCG-vaccinated health care workers compared to placebo. Time: during the study period of 6 months.
Description: Participants presenting any kind of respiratory infection due to any causeMeasure: Incidence of subjects with any respiratory infection among BCG-vaccinated health care workers compared to placebo. Time: during the study period of 6 months.
Description: Numbers of sick days and number of sick leavesMeasure: Numbers of sick days and numbers of sick leaves among BCG-vaccinated health care workers compared to placebo. Time: during the study period of 6 months
Description: Local and general events following BCG revaccination after BCG revaccinationMeasure: Numbers of subjects with BCG-related advers events among BCG-vaccinated health care workers compared to placebo. Time: 30 days after BCG revaccination
Description: Potentially modified markers of innate immunity upon SARS CoV-2 infection to be identifiedMeasure: Numbers and intensity of changes in innate immune markers after SARS CoV2 infection among BCG-vaccinated health care workers compared to placebo. Time: during the study period of 6 months.
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports