|drug3499||Two dose MenACWY vaccine min. 4 weeks apart Wiki||0.50|
|drug2633||Preservative-free saline Wiki||0.50|
|drug4131||vaccine BCG Wiki||0.50|
|drug3497||Two dose ChAdOx1 nCoV-19/Covishield 0.5mL Wiki||0.50|
|drug2003||MenACWY vaccine Wiki||0.50|
|drug653||COVID19 vaccine Wiki||0.50|
|drug736||ChAdOx1 nCoV-19 0.5mL prime plus boost Wiki||0.50|
|drug3498||Two dose MenACWY vaccine Wiki||0.50|
|drug734||ChAdOx1 nCoV-19 (qPCR) Wiki||0.50|
|drug733||ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost Wiki||0.50|
|drug732||ChAdOx1 nCoV-19 (Abs 260) Wiki||0.50|
|drug3422||Tice® BCG (for intravesical use) BCG LIVE strain of the BCG (Merck) vaccine Wiki||0.50|
|drug3496||Two dose ChAdOx1 nCoV-19/Covishield 0.25mL & 0.5mL Wiki||0.50|
|drug367||BCG vaccine Wiki||0.25|
|D018352||Coronavirus Infections NIH||0.16|
|D045169||Severe Acute Respiratory Syndrome NIH||0.10|
There are 4 clinical trials
Bacillus Calmette-Guérin (BCG) vaccine not only protects against tuberculosis, but has also been shown to induce protection against various infections with a viral aetiology, leading to significant reductions in morbidity and mortality. We hypothesize that BCG vaccination might be a potent preventive measure against SARS-CoV-2 infection and/or may reduce disease severity in elderly people, who are known to be at increased risk of illness and death from SARS-CoV-2 infection. Therefore, we will in this placebo-controlled adaptive multi-centre randomized controlled trial evaluate the ability of BCG to reduce hospital admission and its efficacy to improve the clinical course of SARS-CoV-2 infection in elderly people((≥ 60 years of age).
Until the first half of April, Colombia has more than 2,800 infected cases and a hundred deaths as a result of COVID-19, with Antioquia being the third department with the highest number of cases. Official records indicate that, in Colombia, the first case was diagnosed on March 6, 2020, corresponding to a patient from Italy. However, in conversations with several infectologists and intensivists from Medellín, it was agreed that clinical cases similar to the clinical presentation that is now recognized as COVID-19 had arisen since the end of 2019 when it was still unknown to everyone. The previous suggests that the virus was already circulating in the country since before March 6, 2020. But at that moment, there were no tools to make a clinical identification, nor to diagnose it from the laboratory's point of view. Considering as real the hypothesis that the infection has been circulating in the country since before the first official diagnosis, the question arises: Why does not the country still has the same healthcare and humanitarian chaos that countries such as Italy and Spain are suffering at this time? To answer this question may be that there are differences in vaccination rates with BCG (Bacille Calmette-Guérin or tuberculosis vaccine), which is significantly higher in Latin America compared to those in Europe. This finding could explain to some extent the situation in the country, since previous studies have shown the influence that this vaccine can have on the immune response against various other pathogens, including viruses. Among the population at risk of infection, health-care workers due to their permanent contact with patients are the population group with the highest risk of contracting SARS-Cov-2 and developing COVID-19 in any of its clinical manifestations, and currently there are no vaccines or proven preventive interventions available to protect them. For this reason, this research study aims to demonstrate whether the centennial vaccine against tuberculosis (BCG), a bacterial disease, can activate the human immune system in a broad way, allowing it to better combat the coronavirus that causes COVID-19 and, perhaps, prevents the complications that lead the patient to the intensive care unit and death. In the future, and if these results are as expected, they may be the basis for undertaking a population vaccination campaign that improves clinical outcomes in the general population.
Description: Incidence of COVID-19 cases confirmed or probable in the study populationMeasure: Primary outcome Time: From date of randomization to 360 day of the study
Description: Incidence of severe or critical infection in COVID-19 casesMeasure: Secondary outcome Time: From date to diagnosis to 1 month after
Description: Lethality of the infection in both groupsMeasure: Secondary outcome Time: From date to diagnosis to 1 month after
Description: Assess the safety (frequency, seriousness, and severity of adverse events) of BCG vaccinationMeasure: Secondary outcome Time: From date of randomization to 7 day of the study
Description: Prevalence of SARS-Cov-2 infectionMeasure: Secondary outcome Time: At baseline evaluation
To date, there is no vaccine or treatment with proven efficiency against COVID-19, and the transmissibility of the SARS-CoV-2 virus can be inferred by its identification in the oro-nasopharynx. The bacillus Calmette Guérin (BCG) has the potential for cross-protection against viral infections. This study evaluates the impact of previous (priming effect, from the titer of anti-BCG interferon-gamma) or current BCG exposure (boost with intradermal vaccine) on 1) clinical evolution of COVID-19; 2) elimination of SARS-CoV-2 at different times and disease phenotypes; and 3) seroconversion rate and titration (anti-SARS-CoV-2 IgA, IgM, and IgG).
Description: Classified as mild, moderate and severeMeasure: Clinical evolution of COVID-19 Time: 45 days of symptoms onset or diagnosis
Description: Virus detection by PCRMeasure: SARS-CoV-2 elimination Time: 7 days of symptoms onset or diagnosis
Description: Titration of anti SARS-CoV-2 IgA, IgM and IgGMeasure: Seroconversion rate and titration Time: 7 days of symptoms onset or diagnosis
Description: Classified according to type and severityMeasure: Local and systemic adverse events to BCG vaccination Time: 3 months
Description: Virus detection by PCRMeasure: SARS-CoV-2 elimination Time: 21 days of symptoms onset or diagnosis
Description: Titration of anti SARS-CoV-2 IgA, IgM and IgGMeasure: Seroconversion rate Time: 21 days of symptoms onset or diagnosis
Description: Virus detection by PCRMeasure: SARS-CoV-2 elimination Time: 45 days of symptoms onset or diagnosis
Description: Titration of anti SARS-CoV-2 IgA, IgM and IgGMeasure: Seroconversion rate and titration Time: 45 days of symptoms onset or diagnosis
The current COVID-19 epidemic threatens to overwhelm the capacity of many countries to meet their populations' health care needs. Although several vaccines specific for SARS-CoV-2 have been or are being developed, these require testing in animal and human safety studies and they are unlikely to be available during the expected peak periods of the growing epidemic. Two groups at especially high risk of infection and disease are front line health care workers working directly with COVID-19 patients and elderly residents of group homes or facilities that provide skilled nursing care to this frail population. Interim measures to protect these groups while we await a high efficacy vaccine are desperately needed. Based on the capacity of BCG to (1) reduce the incidence of respiratory tract infections in children and adults; (2) exert antiviral effects in experimental models; and (3) reduce viremia in an experimental human model of viral infection, we hypothesize that BCG vaccination may induce (partial) protection against susceptibility to and/or severity of SARS-CoV-2 infection. This study will evaluate the efficacy of BCG to reduce risk of infection by SARS-CoV-2 and mitigate COVID-19 disease severity in at risk health care providers. A phase III randomized controlled trial provides the highest validity to answer this research question. Given the immediate threat of the SARS-CoV-2 epidemic the trial has been designed as a pragmatic study with a highly feasible primary endpoint, which can be continuously measured. This allows for the most rapid identification of a beneficial outcome that would allow other at-risk individuals, including the control population, to also benefit from the intervention if and as soon as it has demonstrated efficacy and safety.
Description: The primary outcome measure is the development of symptomatic COVID 19 infections. We will use the Cox proportional-hazards model to calculate hazard ratios for the development of COVID-19. This will be reported as the incidence of rt-PCR-confirmed symptomatic SARS-CoV-2 infection following BCG vaccination compared to that following placebo, starting from 3 days post-vaccination through 6 months.Measure: Incidence of symptomatic rt-PCR-confirmed SARS-CoV-2 infection Time: 6 months
Description: The secondary outcome measure is the development of Serology-confirmed infection with SARS-CoV-2. We will use the Cox proportional-hazards model to calculate hazard ratios for the development of COVID-19. This will be reported as the incidence of serology-confirmed SARS-CoV-2 following BCG vaccination compared to that following placebo, starting from 3 days post vaccination through 6 months.Measure: incidence of Serology-confirmed infection with SARS-CoV-2 Time: 6 months
Description: In individuals who test positive for COVID-19, the proportion with severe disease following BCG vaccination compared to placebo, as defined by the following necessary care levels: non- hospital care; patient hospitalized but no oxygen required; hospitalized and oxygen required; patient treated in intensive care and/or on mechanical ventilation; patient died.Additional WHO severity indicators of severe pneumonia, respiratory failure, sepsis, septic shock will also be included.Measure: severity of COVID-19 disease Time: 6 months
Description: Incidence of self-reported symptomatic respiratory infections following BCG vaccination compared to that following placebo, starting from 3 days post-vaccination through 6 months.Measure: symptomatic respiratory infection Time: 6 months
Description: rates of 1) all cause respiratory infection 2) symptomatic COVID- 19, 3) serology-confirmed SARS-CoV-2 infection in health care workers.Measure: effect of prior adult immunization with other vaccines associated with trained immunity Time: 6 months
Data processed on January 01, 2021.
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