Covid 19 Research using Clinical Trials (Home Page)
BCG VaccineWiki
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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug621 | Placebo Vaccine Wiki | 0.58 |
| drug910 | XPro1595 Wiki | 0.58 |
| drug239 | Cytokine Adsorption Wiki | 0.58 |
| drug616 | Placebo Wiki | 0.06 |
Correlated MeSH Terms (6)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.12 |
| D018352 | Coronavirus Infections NIH | 0.10 |
| D055371 | Acute Lung Injury NIH | 0.09 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.09 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.08 |
| D014777 | Virus Diseases NIH | 0.06 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 3 clinical trials
Clinical Trials
1 BCG Vaccination to Reduce the Impact of COVID-19 in Australian Healthcare Workers Following Coronavirus Exposure (BRACE) Trial
Open label, two-group, phase III randomised controlled trial in up to 4170 healthcare workers to determine if BCG vaccination reduces the incidence and severity of COVID-19 during the 2020 pandemic.
NCT04327206 Coronavirus Disease 2019 (COVID-19) Febrile Respiratory Illness Corona Virus Infection COVID-19 Drug: BCG Vaccine MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Virus Diseases
Primary Outcomes
Description: Number of participants with COVID-19 disease defined as fever (using self-reported questionnaire), plus at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus positive SARS-Cov-2 test (PCR or serology)
Measure: COVID-19 disease incidence Time: Measured over the 6 months following randomisationDescription: Number of participants who were admitted to hospital or died (using self-reported questionnaire and/or medical/hospital records) in the context of a positive SARS-CoV-2 test
Measure: Severe COVID-19 disease incidence Time: Measured over the 6 months following randomisationSecondary Outcomes
Description: Number of participants with COVID-19 disease defined as fever (using self-reported questionnaire), plus at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus positive SARS-Cov-2 test (PCR or serology)
Measure: COVID-19 incidence by 12 months Time: Measured over the 12 months following randomisationDescription: Number of participants with severe COVID-19 disease defined as hospitalisation or death in the context of a positive SARS-Cov-2 test (PCR or serology)
Measure: Severe COVID-19 incidence by 12 months Time: Measured over the 12 months following randomisationDescription: Time to first symptom of COVID-19 in a participant who subsequently meets the case definition: fever (using self-reported questionnaire), plus at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus positive SARS-Cov-2 test (PCR or serology)
Measure: Time to first symptom of COVID-19 Time: Measured over the 12 months following randomisationDescription: Number of episodes of COVID-19 disease defined as fever (using self-reported questionnaire), plus at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus positive SARS-Cov-2 test (PCR or serology)
Measure: Episodes of COVID-19 Time: Measured over the 12 months following randomisationDescription: Number of participants with asymptomatic SARS-CoV-2 infection defined as Evidence of SARS-CoV-2 infection (by PCR or seroconversion) Absence of respiratory illness (using self-reported questionnaire) No evidence of exposure prior to randomisation (inclusion serology negative)
Measure: Asymptomatic SARS-CoV-2 infection Time: Measured over the 12 months following randomisationDescription: Number of days (using self-reported questionnaire) unable to work (excludes quarantine/workplace restrictions) due to COVID-19 disease defined as fever (using self-reported questionnaire), plus at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus positive SARS-Cov-2 test (PCR or serology)
Measure: Work absenteeism due to COVID-19 Time: Measured over the 12 months following randomisationDescription: Number of days confined to bed (using self-reported questionnaire) due to COVID-19 disease defined as fever (using self-reported questionnaire), plus at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus positive SARS-Cov-2 test (PCR or serology)
Measure: Bed confinement due to COVID-19 Time: Measured over the 12 months following randomisationDescription: Number of days with symptoms in any episode of illness that meets the case definition for COVID-19 disease: fever (using self-reported questionnaire), plus at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus positive SARS-Cov-2 test (PCR or serology)
Measure: Symptom duration of COVID-19 Time: Measured over the 12 months following randomisationDescription: Number of pneumonia cases (abnormal chest X-ray) (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test
Measure: SARS-CoV-2 pneumonia Time: Measured over the 12 months following randomisationDescription: Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test
Measure: Oxygen therapy with SARS-CoV-2 Time: Measured over the 12 months following randomisationDescription: Number of admission to critical care (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test
Measure: Critical care admissions with SARS-CoV-2 Time: Measured over the 12 months following randomisationDescription: Number of days admitted to critical care (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test
Measure: Critical care admission duration with SARS-CoV-2 Time: Measured over the 12 months following randomisationDescription: Number of participants needing mechanical ventilation (using self-reported questionnaire and/or medical/hospital records) and a positive SARS-CoV-2 test
Measure: Mechanical ventilation with SARS-CoV-2 Time: Measured over the 12 months following randomisationDescription: Number of days that participants needed mechanical ventilation (using self-reported questionnaire and/or medical/hospital records) and a positive SARS-CoV-2 test
Measure: Mechanical ventilation duration with SARS-CoV-2 Time: Measured over the 12 months following randomisationDescription: Number of days of hospitalisation due to COVID-19 (using self-reported questionnaire and/or medical/hospital records).
Measure: Hospitalisation duration with COVID-19 Time: Measured over the 12 months following randomisationDescription: Number of deaths (from death registry) associated with a positive SARS-CoV-2 test
Measure: Mortality with SARS-CoV-2 Time: Measured over the 12 months following randomisationDescription: Number of participants with febrile respiratory illness defined as fever (using self-reported questionnaire), plus at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)
Measure: Febrile respiratory illness Time: Measured over the 12 months following randomisationDescription: Number of episodes of febrile respiratory illness, defined as fever (using self-reported questionnaire), plus at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)
Measure: Episodes of febrile respiratory illness Time: Measured over the 12 months following randomisationDescription: Number of days (using self-reported questionnaire) unable to work (excludes quarantine/workplace restrictions) due to febrile respiratory illness defined as fever (using self-reported questionnaire), plus at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)
Measure: Work absenteeism due to febrile respiratory illness Time: Measured over the 12 months following randomisationDescription: Number of days confined to bed (using self-reported questionnaire) due to febrile respiratory illness defined as fever (using self-reported questionnaire), plus at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)
Measure: Bed confinement due to febrile respiratory illness Time: Measured over the 12 months following randomisationDescription: Number of days with symptoms in any episode of illness that meets the case definition for febrile respiratory illness: fever (using self-reported questionnaire), plus at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)
Measure: Symptom duration of febrile respiratory illness Time: Measured over the 12 months following randomisationDescription: Number of pneumonia cases (abnormal chest X-ray) (using self-reported questionnaire and/or medical/hospital records)
Measure: Pneumonia Time: Measured over the 12 months following randomisationDescription: Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records)
Measure: Oxygen therapy Time: Measured over the 12 months following randomisationDescription: Number of admission to critical care (using self-reported questionnaire and/or medical/hospital records)
Measure: Critical care admissions Time: Measured over the 12 months following randomisationDescription: Number of participants needing mechanical ventilation (using self-reported questionnaire and/or medical/hospital records)
Measure: Mechanical ventilation Time: Measured over the 12 months following randomisationDescription: Number of deaths (from death registry)
Measure: Mortality Time: Measured over the 12 months following randomisationDescription: Number of days of hospitalisation due to febrile respiratory illness (using self-reported questionnaire and/or medical/hospital records)
Measure: Hospitalisation duration with febrile respiratory illness Time: Measured over the 12 months following randomisationDescription: Number of days of unplanned absenteeism for any reason (using self-reported questionnaire)
Measure: Unplanned work absenteeism Time: Measured over the 12 months following randomisationDescription: Cost of hospitalisation due to COVID-19 reported in Australian dollars (using hospital administrative linked costing records held by individual hospitals and state government routine costing data collections to provide an estimate of the cost to hospitals for each episode of COVID-19 care)
Measure: Hospitalisation cost to treat COVID-19 Time: Measured over the 12 months following randomisationDescription: Type and severity of local and systemic adverse events will be collected in self-reported questionnaire and graded using toxicity grading scale.
Measure: Local and systemic adverse events to BCG vaccination in healthcare workers Time: Measured over the 3 months following randomisation2 Reducing Health Care Workers Absenteeism in COVID-19 Pandemic by Enhanced Trained Immune Responses Through Bacillus Calmette-Guérin Vaccination, a Randomized Controlled Trial.
Rationale: Covid-19 spreads rapidly throughout the world. A large epidemic in the Netherlands would seriously challenge the available hospital capacity, and this would be augmented by absenteeism of healthcare workers (HCW). Strategies to prevent absenteeism of HCW are, therefore, desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, and reported significant reductions in morbidity and mortality. The hypothesis is that BCG vaccination can reduce HCW absenteeism during the epidemic phase of Covid-19. Objective: Primary objective: To reduce absenteeism among HCW with direct patient contacts during the epidemic phase of Covid-19. Secondary objective: To reduce hospital admission, ICU admission or death in HCW with direct patient contacts during the epidemic phase of Covid-19. Study design: A placebo-controlled adaptive multi-centre randomized controlled trial. Study population: HCW with direct patient contacts among which nurses and physicians working at emergency rooms and wards where Covid-19-infected patients are treated. Intervention: Participants will be randomized between intracutaneous administration of BCG vaccine or placebo in a 1:1 ratio. Main study parameters/endpoints: Primary endpoint: number of days of (unplanned) absenteeism for any reason. Secondary endpoints include the number of days of (unplanned) absenteeism because of documented Covid-19 infection, and the cumulative incidence of hospital admission, Intensive Care Admission, and death. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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 beneficial effects of BCG vaccination through a lower work absenteeism rate of HCW and/or a mitigated clinical course of Covid-19 infection. The primary endpoint and the adaptive design with frequent interim analyses facilitate maximum efficiency of the trial, so that results can inform policy making during the ongoing epidemic.
NCT04328441 COVID-19 Drug: BCG Vaccine Drug: Placebo
Primary Outcomes
Description: Number of days of unplanned absenteeism for any reason
Measure: Health Care Workers absenteeism Time: Maximum of 180 daysSecondary Outcomes
Measure: the cumulative incidence of documented COVID-19 Time: Maximum of 180 daysMeasure: the cumulative incidence of Hospital Admission due to documented COVID-19 Time: Maximum of 180 days
Measure: the number of days of unplanned absenteeism, because of documented COVID-19 Time: Maximum of 180 days
Measure: the cumulative incidence of self-reported acute respiratory symptoms or fever Time: Maximum of 180 days
Measure: the cumulative incidence of death due to documented COVID-19 Time: Maximum of 180 days
Measure: the cumulative incidence of Intensive Care Admission due to documented COVID-19 Time: Maximum of 180 days
Description: Exploratory
Measure: the number of days of absenteeism, because of imposed quarantine as a result of exposure to COVID-19 Time: Maximum of 180 daysDescription: Exploratory
Measure: the number of days of absenteeism, because of imposed quarantine as a result of having acute respiratory symptoms, fever or documented COVID-19 Time: Maximum of 180 daysDescription: Exploratory
Measure: the number of days of unplanned absenteeism because of self-reported acute respiratory symptoms Time: Maximum of 180 daysDescription: Exploratory
Measure: the number of days of self-reported fever (≥38 gr C) Time: Maximum of 180 daysDescription: Exploratory
Measure: the cumulative incidence of self-reported fever (≥38 gr C) Time: Maximum of 180 daysDescription: Exploratory
Measure: the number of days of self-reported acute respiratory symptoms Time: Maximum of 180 daysDescription: Exploratory
Measure: the cumulative incidence of self-reported acute respiratory symptoms Time: Maximum of 180 daysDescription: Exploratory
Measure: the cumulative incidence of death for any reason Time: Maximum of 180 daysDescription: Exploratory
Measure: the cumulative incidence of Intensive Care Admission for any reason Time: Maximum of 180 daysDescription: Exploratory
Measure: the cumulative incidence of Hospital Admission for any reason Time: Maximum of 180 daysDescription: Exploratory
Measure: • the cumulative incidence and magnitude of plasma/serum antibodies (IgA,M,G) and SARS-CoV-2-specific antibodies at 12 weeks after vaccination and at the end of the study period Time: Maximum of 180 days3 Bacillus Calmette-Guerin Vaccination as Defense Against SARS-CoV-2: A Randomized Controlled Trial to Protect Health Care Workers by Enhanced Trained Immune Responses
SARS-CoV-2 spreads rapidly throughout the world. A large epidemic would seriously challenge the available hospital capacity, and this would be augmented by infection of healthcare workers (HCW). Strategies to prevent infection and disease severity of HCW are, therefore, desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, and reported morbidity and mortality reductions as high as 70%. Furthermore, in our preliminary analysis, areas with existing BCG vaccination programs appear to have lower incidence and mortality from COVID191. The investigators hypothesize that BCG vaccination can reduce HCW infection and disease severity during the epidemic phase of SARS-CoV-2.
NCT04348370 Coronavirus Coronavirus Infection Coronavirus as the Cause of Diseases Classified Elsewhere Biological: BCG Vaccine Biological: Placebo Vaccine MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome
Primary Outcomes
Description: The primary outcome measure is the development of COVID19 infection. We will use the Cox proportional-hazards model to calculate hazard ratios for the development of Covid-19. This will be reported as the proportion of individuals receiving the intervention who are PCR-positive or seroconvert. defined as number of new cases during the 6 month time period
Measure: Incidence of COVID 19 Infection Time: 6 monthsSecondary Outcomes
Description: The secondary outcome measure is disease severity calculated using the Covid Severity Scale Scoring of 0 -10. A score of 10 is worse and a score of 0 is best. Disease severity score will be based on the level of care required for individuals who test positive for COVID19 as follows: non-hospital-based 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 criteria for severity include severe pneumonia, respiratory failure, acute respiratory distress syndrome, sepsis and septic shock.
Measure: Disease Severity Time: up to 6 months