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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2474 | Personal protective equipment Wiki | 0.71 |
| drug2097 | Mucodentol Wiki | 0.71 |
| drug2521 | Placebo Comparator Wiki | 0.50 |
Navigate: Correlations HPO
There are 2 clinical trials
A novel betacoronavirus, SARS-CoV-2, is spreading rapidly throughout the world. A large epidemic in South Africa may overwhelm available hospital capacity and healthcare resources which would be worsened by absenteeism of healthcare workers and other frontline staff (HCW). Strategies to prevent morbidity and mortality of HCW are desperately needed to safeguard continuous patient care. Bacillus Calmette-Guérin (BCG) is a vaccine against tuberculosis (TB), with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, with reported morbidity and mortality reductions as high as 70%. We hypothesize that a BCG vaccination may reduce the morbidity and mortality of healthcare workers during the COVID-19 outbreak in South Africa.
Description: To compare the incidence of HCWs hospitalized due to COVID-19 per arm.
Measure: Incidence of HCWs hospitalized due to COVID-19 per arm Time: 52 weeksDescription: To determine the incidence of SARS-CoV-2 infection in HCW by molecular or serological testing (as available) at entry, 10, 26 and/or 52 weeks.
Measure: Incidence of SARS-CoV-2 infection per arm Time: 52 weeksDescription: To compare the incidence of symptoms of upper respiratory tract infection per arm.
Measure: Incidence of upper respiratory tract infections per arm Time: 52 weeksDescription: To compare the number of days of (unplanned) absenteeism because of documented SARS-CoV-2 infection, COVID-19 or any reason per arm.
Measure: Days of unplanned absenteeism due to COVID-19 or any reason per arm Time: 52 weeksDescription: To compare the incidence of hospitalization of HCW for any reason per arm.
Measure: Incidence of hospitalization for any reason per arm Time: 52 weeksDescription: To compare the incidence of intensive care admission of HCW due to COVID-19 or any reason per arm.
Measure: Incidence of intensive care unit admission per arm Time: 52 weeksDescription: To compare the incidence of death of HCW due to COVID-19 or any reason per arm.
Measure: Incidence of death per arm Time: 52 weeksDescription: To describe the prevalence of latent TB infection as determined by interferon gamma release assay (IGRA) at enrolment and at week 52.
Measure: Prevalence of latent TB infection Time: 52 weeksDescription: To compare the incidence of active TB of HCW per arm.
Measure: Incidence of active TB per arm Time: 52 weeksDescription: To compare the effect of latent TB infection on morbidity and mortality of HCW due to COVID-19 per arm. The risk of morbidity and mortality of latent TB infected individuals is not known, we will examine whether there is a higher risk of disease severity and poor outcomes in this group.
Measure: Compare the effect of latent TB on morbidity and mortality due to COVID-19 per arm Time: 52 weeksDescription: To compare the incidence of grade 2 or higher adverse events and vaccination site reactions per arm.
Measure: Incidence of treatment related adverse events Time: 52 weeksOn March 11 2020 the World Health Organization (WHO) declared the coronavirus (SARS-CoV-2) outbreak a pandemic. Worldwide, the number of confirmed cases continues to rise, leading to significant morbidity and mortality. In the Netherlands, although the incidence is currently low due to social distancing measures, recurrence of infections is expected once measures are going to be lifted. Although individuals of any age can acquire SARS-CoV-2, adults of middle and older age are at highest risk for developing severe COVID-19 disease. Moreover, recent reports demonstrate that mortality rates rise significantly among patients 60 years and older. Therefore, strategies to prevent SARS-CoV-2 infection or to reduce its clinical consequences in vulnerable populations are urgently needed. Bacille Calmette-Guérin (BCG) vaccine not only protects against tuberculosis, but also induces protection against various respiratory infections, including those with a viral etiology. We hypothesize that BCG vaccination reduces clinically relevant respiratory tract infections requiring medical intervention, including COVID-19, in vulnerable elderly. The objective of this trial is to determine the impact of BCG vaccination on the incidence of clinically relevant respiratory infections or COVID-19 in vulnerable elderly. The trial is designed as an adaptive multi-center double-blind randomized placebo-controlled trial. The attempt is to include 5,200 to 7,000 vulnerable elderly, defined as ≥60 years of age being discharged from hospital in the last 6 weeks, or visiting a medical outpatient clinic, thrombosis care services, or chronic renal replacement departments. Patients with contraindications to BCG vaccination as stipulated in the Summary of Product Characteristics (SPC) and patients with a history of COVID-19 will be excluded. Participants will be randomized between intracutaneous administration of BCG vaccine (Danish strain 1331) or placebo (0.1ml 0.9% NaCl) in a 1:1 ratio.The trial has an adaptive primary endpoint. Based on accrual of the two endpoints, the primary endpoint will be either (a) COVID-19 or (b) clinically relevant respiratory tract infection requiring medical intervention, potentially including COVID-19 episodes. The other will be declared secondary endpoint. Other secondary endpoints include: all SARS-CoV-2 infections (including asymptomatic infections), influenza infection, acute respiratory infection (ARI; all infections regardless of medical intervention), ARI-related hospital admission, COVID-19 related hospital admission, pneumonia, mental, physical and social functioning, serious adverse events and adverse events, and death.
Description: Clinically relevant relevant respiratory tract infection is composed of clinical symptoms in combination with the need for medical intervention. Exact criteria for clinically relevant respiratory tract infection and COVID-19 are described in the protocol. A blinded adjudication committee will determine the status of the primary endpoints of all participants with a potential primary endpoint, based on information provided in a standardized narrative using data reported by the participant and from GP and hospital medical records when relevant. For detection of ARI, symptoms are checked on a weekly (from week 1-4) or bi-weekly basis (from week 4 onward).
Measure: The trial has an adaptive primary endpoint. Based on predefined objective and quantitative criteria the primary endpoint will be either a clinically relevant respiratory tract infection, or COVID-19. Time: 180 daysDescription: Cumulative incidence of SARS-CoV-2 infection regardless of symptomatology defined as having had COVID-19 as described under primary endpoints above and/or SARS-CoV-2 positive test in real time as part of the test-and-trace program of the Dutch government and/of documented SARS-CoV-2 seroconversion at 6 months. Seroconversion will be defined as antibody-positive at 6 months but negative at baseline.
Measure: Cumulative incidence of SARS-CoV-2 infection (irrespective the presence of symptoms) Time: 180 daysDescription: Defined as either of 1) ARI + microbiological evidence of influenza infection, 2) seroconversion of influenza between enrolment and month 6.
Measure: Influenza infection Time: 180 daysDescription: Meeting the definition stated in the primary outcome. Irrespective of requiring an intervention.
Measure: An acute respiratory tract infection Time: 180 daysDescription: Meeting the definition stated in the primary outcome including the requirement of an intervention.
Measure: Medically attended acute respiratory tract infection Time: 180 daysDescription: Meeting the definition stated in the primary outcome including the need of hospitalization.
Measure: Acute respiratory tract infection related hospital admission Time: 180 daysDescription: Using the Katz Activities of Daily Living (ADL) scale, from A (fully independent) to G (dependent in feeding, continence, transferring, going to toilet, dressing, and bathing)
Measure: Functioning in daily activities Time: 180 daysDescription: Using the EQ5D quality of life instrument, with questions on 4 domains (mobility, self-care, usual activities, pain discomfort) and the percepted health of the participant with 100 meaning the best health you can imagine, and 0 meaning the worst health you can imagine
Measure: Quality of life using the EQ5D quality of life instrument Time: 180 daysDescription: Using the 6-item Lawton Activities of Daily Living questionnaire, with scores ranging from 0 (low function, dependent) to 8 (high function, independent) for women (0 through 5 for men)
Measure: Activities in daily living Time: 180 daysAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 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