CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


BCG VaccineWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (6)


Name (Synonyms) Correlation
drug1081 Human umbilical cord mesenchymal stem cells + best supportive care Wiki 0.58
drug1838 Placebo Vaccine Wiki 0.58
drug11 0.9%NaCl Wiki 0.58
drug1616 No intervention / Evaluation of the ferritin and glycosylated ferritin by standard approved serological tests Wiki 0.58
drug2539 Tofacitinib 10 mg Wiki 0.41
drug1822 Placebo Wiki 0.07

Correlated MeSH Terms (6)


Name (Synonyms) Correlation
D013577 Syndrome NIH 0.06
D045169 Severe Acute Respiratory Syndrome NIH 0.06
D055371 Acute Lung Injury NIH 0.06
D012127 Respiratory Distress Syndrome, Newborn NIH 0.06
D012128 Respiratory Distress Syndrome, Adult NIH 0.05
D018352 Coronavirus Infections NIH 0.05

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 Healthcare Workers Following Coronavirus Exposure (BRACE) Trial

Phase III, two-group multicentre, randomised controlled trial in up to 10 078 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) Respiratory Illness Corona Virus Infection COVID-19 Drug: BCG Vaccine Drug: 0.9%NaCl
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of participants with COVID-19 disease defined as positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)

Measure: COVID-19 disease incidence

Time: Measured over the 6 months following randomisation

Description: Number of participants with severe COVID-19 disease, defined as: COVID-19 disease with hospitalisation, death, or non-hospitalised severe disease. Non-hospitalised severe disease is defined as non-ambulant (*) for ≥ 3 consecutive days OR unable to work (**) for ≥ 3 consecutive days. (*) "pretty much confined to bed (meaning finding it very difficult to do any normal daily activities". (**) "I do not feel physically well enough to go to work"

Measure: Severe COVID-19 disease incidence

Time: Measured over the 6 months following randomisation

Secondary Outcomes

Description: Number of participants with COVID-19 disease defined as positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)

Measure: COVID-19 incidence by 12 months

Time: Measured over the 12 months following randomisation

Description: Number of participants with severe COVID-19 disease, defined as: COVID-19 disease with hospitalisation, death, or non-hospitalised severe disease. Non-hospitalised severe disease is defined as non-ambulant(*) for ≥ 3 consecutive days OR unable to work (**) for ≥ 3 consecutive days. * "pretty much confined to bed (meaning finding it very difficult to do any normal daily activities" ** "I do not feel physically well enough to go to work"

Measure: Severe COVID-19 incidence by 12 months

Time: Measured over the 12 months following randomisation

Description: Time to first symptom of COVID-19 in a participant who subsequently meets the case definition: positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)

Measure: Time to first symptom of COVID-19

Time: Measured over the 12 months following randomisation

Description: Number of episodes of COVID-19 disease defined as positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)

Measure: Episodes of COVID-19

Time: Measured over the 12 months following randomisation

Description: 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 randomisation

Description: Number of days (using self-reported questionnaire) unable to work (excludes quarantine/workplace restrictions) due to COVID-19 disease defined as positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)

Measure: Work absenteeism due to COVID-19

Time: Measured over the 12 months following randomisation

Description: Number of days confined to bed (using self-reported questionnaire) due to COVID-19 disease defined as positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)

Measure: Bed confinement due to COVID-19

Time: Measured over the 12 months following randomisation

Description: Number of days with symptoms in any episode of illness that meets the case definition for COVID-19 disease: positive SARS-Cov-2 test (PCR or serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)

Measure: Symptom duration of COVID-19

Time: Measured over the 12 months following randomisation

Description: 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 randomisation

Description: 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 randomisation

Description: 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 randomisation

Description: 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 randomisation

Description: 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 randomisation

Description: 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 randomisation

Description: 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 randomisation

Description: 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 randomisation

Description: Number of participants with fever or respiratory illness will be defined as: fever (using self-reported questionnaire), or 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: Fever or respiratory illness

Time: Measured over the 12 months following randomisation

Description: Number of episodes of fever or respiratory illness, defined as fever (using self-reported questionnaire), or 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 fever or respiratory illness

Time: Measured over the 12 months following randomisation

Description: Number of days (using self-reported questionnaire) unable to work (excludes quarantine/workplace restrictions) due to fever or respiratory illness defined as fever (using self-reported questionnaire), or 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 fever or respiratory illness

Time: Measured over the 12 months following randomisation

Description: Number of days confined to bed (using self-reported questionnaire) due to fever or respiratory illness defined as fever (using self-reported questionnaire), or 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 fever or respiratory illness

Time: Measured over the 12 months following randomisation

Description: Number of days with symptoms in any episode of illness that meets the case definition for fever or respiratory illness: fever (using self-reported questionnaire), or 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 fever or respiratory illness

Time: Measured over the 12 months following randomisation

Description: 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 randomisation

Description: Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records)

Measure: Oxygen therapy

Time: Measured over the 12 months following randomisation

Description: 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 randomisation

Description: 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 randomisation

Description: Number of deaths (from death registry)

Measure: Mortality

Time: Measured over the 12 months following randomisation

Description: Number of days of hospitalisation due to fever or respiratory illness (using self-reported questionnaire, medical/hospital records and/or government registries)

Measure: Hospitalisation duration with fever or respiratory illness

Time: Measured over the 12 months following randomisation

Description: Number of days of unplanned absenteeism for any reason (using self-reported questionnaire)

Measure: Unplanned work absenteeism

Time: Measured over the 12 months following randomisation

Description: Cost of hospitalisation due to COVID-19 will be reported and compared between groups (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 randomisation

Description: 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 randomisation

2 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 days

Secondary Outcomes

Measure: the cumulative incidence of documented COVID-19

Time: Maximum of 180 days

Measure: 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 days

Description: 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 days

Description: Exploratory

Measure: the number of days of unplanned absenteeism because of self-reported acute respiratory symptoms

Time: Maximum of 180 days

Description: Exploratory

Measure: the number of days of self-reported fever (≥38 gr C)

Time: Maximum of 180 days

Description: Exploratory

Measure: the cumulative incidence of self-reported fever (≥38 gr C)

Time: Maximum of 180 days

Description: Exploratory

Measure: the number of days of self-reported acute respiratory symptoms

Time: Maximum of 180 days

Description: Exploratory

Measure: the cumulative incidence of self-reported acute respiratory symptoms

Time: Maximum of 180 days

Description: Exploratory

Measure: the cumulative incidence of death for any reason

Time: Maximum of 180 days

Description: Exploratory

Measure: the cumulative incidence of Intensive Care Admission for any reason

Time: Maximum of 180 days

Description: Exploratory

Measure: the cumulative incidence of Hospital Admission for any reason

Time: Maximum of 180 days

Description: 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 days

3 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 months

Secondary 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


No related HPO nodes (Using clinical trials)