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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04327206
Registration number
NCT04327206
Ethics application status
Date submitted
25/03/2020
Date registered
31/03/2020
Titles & IDs
Public title
BCG Vaccination to Protect Healthcare Workers Against COVID-19
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Scientific title
BCG Vaccination to Reduce the Impact of COVID-19 in Healthcare Workers (BRACE) Trial
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Secondary ID [1]
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U1111-1256-4104
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Secondary ID [2]
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62586
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Universal Trial Number (UTN)
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Trial acronym
BRACE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronavirus Disease 2019 (COVID-19)
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Respiratory Illness
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Corona Virus Infection
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COVID-19
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Condition category
Condition code
Infection
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0
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Other infectious diseases
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Respiratory
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BCG Vaccine
Treatment: Drugs - 0.9%NaCl
Experimental: BCG vaccine - Participants will receive a single dose of BCG vaccine (BCG-Denmark). The adult dose of BCG vaccine is 0.1 mL injected intradermally over the distal insertion of the deltoid muscle onto the humerus (approximately one third down the upper arm).
Placebo comparator: 0.9% Saline - Participants will receive a single 0.1 mL dose of 0.9%NaCl injected intradermally over the distal insertion of the deltoid muscle onto the humerus (approximately one third down the upper arm).
Treatment: Drugs: BCG Vaccine
Freeze-dried powder: Live attenuated strain of Mycobacterium bovis (BCG), Danish strain 1331.
Each 0.1 ml vaccine contains between 200000 to 800000 colony forming units. Adult dose is 0.1 ml given by intradermal injection
Treatment: Drugs: 0.9%NaCl
0.9% Sodium Chloride Injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Symptomatic COVID-19 by 6 months
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Assessment method [1]
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Number of participants with Symptomatic COVID-19 defined as
* positive SARS-Cov-2 test (PCR, RAT 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)
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Timepoint [1]
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Measured over the 6 months following randomisation
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Primary outcome [2]
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Severe COVID-19 incidence over 6 months
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Assessment method [2]
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Number of participants with severe COVID-19 defined as:
* positive SARS-CoV-2 test (PCR, RAT or serology), PLUS
* death as a consequence of COVID-19, OR
* Hospitalised as a consequence of COVID-19, OR
* Non-hospitalised severe disease as a consequence of COVID-19, defined as non- ambulant\* for = 3 consecutive days 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"
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Timepoint [2]
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Measured over the 6 months following randomisation
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Secondary outcome [1]
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Symptomatic COVID-19 by 12 months
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Assessment method [1]
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Number of participants symptomatic COVID-19 disease defined as
* positive SARS-Cov-2 test (PCR, RAT 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)
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Timepoint [1]
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Measured over the 12 months following randomisation
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Secondary outcome [2]
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Severe COVID-19 incidence over 12 months
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Assessment method [2]
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Number of participants with severe COVID-19 defined as:
* positive SARS-CoV-2 test (PCR, RAT or serology), PLUS
* death as a consequence of COVID-19, OR
* Hospitalised as a consequence of COVID-19, OR
* Non-hospitalised severe disease as a consequence of COVID-19, defined as non- ambulant\* for = 3 consecutive days 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"
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Timepoint [2]
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Measured over the 12 months following randomisation
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Secondary outcome [3]
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Time to first symptom of COVID-19
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Assessment method [3]
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Participants who had either a symptomatic or severe COVID-19 episode will have time to first symptom of COVID-19 calculated as:
\[Date of any symptom onset for the first symptomatic or severe COVID-19 episode - Date of randomisation\]
Participants who have not had a symptomatic or severe COVID-19 episode will have time calculated as:
\[Earliest censoring date - date of randomisation\]
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Timepoint [3]
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Measured over the 6 and 12 months following randomisation
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Secondary outcome [4]
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Number of Episodes of COVID-19
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Assessment method [4]
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The total number of symptomatic or severe COVID-19 episodes (refer to outcome 3 and 4 for definitions)
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Timepoint [4]
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Measured over the 6 and 12 months following randomisation
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Secondary outcome [5]
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Asymptomatic SARS-CoV-2 infection
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Assessment method [5]
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Number of participants with asymptomatic SARS-CoV-2 infection defined as
* Evidence of SARS-CoV-2 infection (by seroconversion)
* Absence of respiratory illness (defined by trigger or non-trigger symptoms)(using self- reported questionnaire)
* No evidence of exposure prior to randomisation
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Timepoint [5]
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0
Measured over the 6 and 12 months following randomisation
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Secondary outcome [6]
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Work absenteeism due to COVID-19
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Assessment method [6]
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Number of days (using self-reported questionnaire) unable to work (excludes quarantine/workplace restrictions) due to COVID-19 defined as
* positive SARS-Cov-2 test (PCR, RAT 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)
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Timepoint [6]
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0
Measured within 6 and 12 months following randomisation
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Secondary outcome [7]
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Bed confinement due to COVID-19
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Assessment method [7]
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Number of days confined to bed (using self-reported questionnaire) due to COVID-19 disease defined as
* positive SARS-Cov-2 test (PCR, RAT 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)
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Timepoint [7]
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0
Measured over 6 and 12 months following randomisation
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Secondary outcome [8]
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Symptom duration of COVID-19
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Assessment method [8]
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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, RAT 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)
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Timepoint [8]
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0
Measured over 6 and12 months following randomisation
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Secondary outcome [9]
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Pneumonia due to COVID-19
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Assessment method [9]
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Number of pneumonia cases (using self-reported questionnaire and/or medical/hospital records) due to COVID-19
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Timepoint [9]
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0
Measured over the 6 and 12 months following randomisation
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Secondary outcome [10]
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Oxygen therapy due to COVID-19
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Assessment method [10]
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Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records) due to COVID-19
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Timepoint [10]
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0
Measured over the 6 and12 months following randomisation
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Secondary outcome [11]
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Critical care admissions due to COVID-19
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Assessment method [11]
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Number of admission to critical care (using self-reported questionnaire and/or medical/hospital records) due to COVID-19
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Timepoint [11]
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Measured over the 6 and 12 months following randomisation
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Secondary outcome [12]
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Mechanical ventilation due to COVID-19
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Assessment method [12]
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Number of participants needing mechanical ventilation (using self-reported questionnaire and/or medical/hospital records)
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Timepoint [12]
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Measured over the 12 months following randomisation
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Secondary outcome [13]
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Hospitalisation duration with COVID-19
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Assessment method [13]
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Number of days of hospitalisation due to COVID-19 (using self-reported questionnaire and/or medical/hospital records).
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Timepoint [13]
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Measured over the 6 and 12 months following randomisation
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Secondary outcome [14]
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Mortality due to COVID-19
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Assessment method [14]
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Number of deaths due to COVID-19
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Timepoint [14]
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Measured over the 6 and 12 months following randomisation
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Secondary outcome [15]
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Fever or respiratory illness
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Assessment method [15]
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Respiratory illness using self-reported questionnaire defined as:
* at least one sign or symptom of respiratory disease including cough, sore throat, shortness of breath, respiratory distress/failure, or runny/blocked nose (in combination with another respiratory symptom or fever).
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Timepoint [15]
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Measured over the 12 months following randomisation
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Secondary outcome [16]
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Severe fever or respiratory illness
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Assessment method [16]
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Severe fever or respiratory illness using self-reported questionnaire defined as:
* Death, or
* Hospitalised, or
* Non-hospitalised severe disease, defined as non-ambulant1 for = 3 consecutive days or unable to work2 for = 3 consecutive days
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Timepoint [16]
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0
Measured over the 12 months following randomisation
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Secondary outcome [17]
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Episodes of fever or respiratory illness
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Assessment method [17]
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Respiratory illness using self-reported questionnaire defined as:
* at least one sign or symptom of respiratory disease including cough, sore throat, shortness of breath, respiratory distress/failure, or runny/blocked nose (in combination with another respiratory symptom or fever).
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Timepoint [17]
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0
Measured over the 12 months following randomisation
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Secondary outcome [18]
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Work absenteeism due to fever or respiratory illness
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Assessment method [18]
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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)
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Timepoint [18]
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0
Measured over the 12 months following randomisation
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Secondary outcome [19]
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Bed confinement due to fever or respiratory illness
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Assessment method [19]
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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)
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Timepoint [19]
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0
Measured over the 12 months following randomisation
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Secondary outcome [20]
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Symptom duration of fever or respiratory illness
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Assessment method [20]
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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)
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Timepoint [20]
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0
Measured over the 12 months following randomisation
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Secondary outcome [21]
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Pneumonia within a febrile or respiratory illness
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Assessment method [21]
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Number of pneumonia cases(using self-reported questionnaire and/or medical/hospital records)
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Timepoint [21]
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0
Measured over the 12 months following randomisation
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Secondary outcome [22]
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Oxygen therapy for a febrile or respiratory illness
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Assessment method [22]
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Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records)
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Timepoint [22]
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0
Measured over the 12 months following randomisation
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Secondary outcome [23]
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Critical care admissions for a febrile or respiratory illness
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Assessment method [23]
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Number of admission to critical care (using self-reported questionnaire and/or medical/hospital records)
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Timepoint [23]
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Measured over the 12 months following randomisation
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Secondary outcome [24]
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Mechanical ventilation for a febrile or respiratory illness
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Assessment method [24]
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Number of participants needing mechanical ventilation (using self-reported questionnaire and/or medical/hospital records)
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Timepoint [24]
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0
Measured over the 12 months following randomisation
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Secondary outcome [25]
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Mortality as a consequence of an episode of fever or respiratory illness
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Assessment method [25]
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Number of deaths
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Timepoint [25]
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Measured over the 12 months following randomisation
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Secondary outcome [26]
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Hospitalisation duration for a febrile or respiratory illness
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Assessment method [26]
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Number of days of hospitalisation due to fever or respiratory illness (using self-reported questionnaire, medical/hospital records)
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Timepoint [26]
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Measured within 6 and 12 months following randomisation
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Secondary outcome [27]
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Unplanned work absenteeism for an acute illness or hospitalisation
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Assessment method [27]
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Number of days of unplanned absenteeism for any reason (using self-reported questionnaire)
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Timepoint [27]
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Measured over the 6 and 12 months following randomisation
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Secondary outcome [28]
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Local and systemic adverse events to BCG vaccination in healthcare workers
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Assessment method [28]
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Adverse events (AEs), over the 3 months following randomisation, by type, severity (graded using toxicity grading scale), relationship to intervention of adverse events (AEs) of interest.
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Timepoint [28]
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Measured over the 3 months following randomisation
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Secondary outcome [29]
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Serious Adverse Events (SAEs) to BCG vaccination in healthcare workers
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Assessment method [29]
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SAEs over the 3 months following randomisation, by type, severity (graded using toxicity grading scale), relationship to intervention.
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Timepoint [29]
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Measured over the 3 months following randomisation
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Eligibility
Key inclusion criteria
* Over 18 years of age
* Healthcare worker
* This is defined as anyone who works in a healthcare setting or has face to face contact with patients.
* Provide a signed and dated informed consent form
* Australian sites only: If annual influenza vaccination is available, receiving the flu vaccine is an eligibility requirement. The flu vaccine will be required a minimum of 3 days in advance of randomisation in the BRACE trial.
* Pre-randomisation blood collected
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Has any BCG vaccine contraindication
* Fever or generalised skin infection (where feasible, randomisation can be delayed until cleared)
* Weakened resistance toward infections due to a disease in/of the immune system
* Receiving medical treatment that affects the immune response or other immunosuppressive therapy in the last year.
* These therapies include systemic corticosteroids (=20 mg for =2 weeks), non-biological immunosuppressant (also known as 'DMARDS'), biological agents (such as monoclonal antibodies against tumour necrosis factor (TNF)-alpha).
* People with congenital cellular immunodeficiencies, including specific deficiencies of the interferon-gamma pathway
* People with malignancies involving bone marrow or lymphoid systems
* People with any serious underlying illness (such as malignancy)
* NB: People with cardiovascular disease, hypertension, diabetes, and/or chronic respiratory disease are eligible if not immunocompromised, and if they meet other eligibility criteria
* Known or suspected HIV infection,even if they are asymptomatic or have normal immune function.
* This is because of the risk of disseminated BCG infection
* People with active skin disease such as eczema, dermatitis or psoriasis at or near the site of vaccination
* A different adjacent site on the upper arm can be chosen if necessary
* Pregnant
* Although there is no evidence that BCG vaccination is harmful during pregnancy, it is a contra-indication to BCG vaccination. Therefore, we will exclude women who think they could be pregnant or are planning to become pregnant within the next month.
* UK specific: Although there is no evidence that BCG vaccination is harmful during pregnancy, it is a contra-indication to BCG vaccination. Therefore, we will exclude women of childbearing potential (WOCBP) who think they could be pregnant.
* Spain specific: If the patient is female, and of childbearing potential, she must have a negative pregnancy test at the time of inclusion and practice a reliable method of birth control for 30 days after receiving the BCG vaccination.
* Another live vaccine administered in the month prior to randomisation
* Require another live vaccine to be administered within the month following BCG randomisation
* If the other live vaccine can be given on the same day, this exclusion criteria does not apply
* Known anaphylactic reaction to any of the ingredients present in the BCG vaccine
* Previous active TB disease
* Currently receiving long term (more than 1 month) treatment with isoniazid, rifampicin or quinolone as these antibiotics have activity against Mycobacterium bovis
* Previous adverse reaction to BCG vaccine (significant local reaction (abscess) or suppurative lymphadenitis)
* BCG vaccine given within the last year
* Have previously had a SARS-CoV-2 positive test result (positive PCR on a respiratory sample or a positive SARS-CoV-2 diagnostic antigen test approved by the local jurisdiction's public health policy)
* Already part of this trial, recruited at a different site/hospital.
* Participation in another COVID-19 prevention trial
* Have previously received a COVID-19-specific vaccine
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/03/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
27/05/2022
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Sample size
Target
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Accrual to date
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Final
6828
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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St Vincent's Hospital, Sydney - Sydney
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Recruitment hospital [2]
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Prince of Wales Hospital - Sydney
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Recruitment hospital [3]
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Sydney Children's Hospital, Randwick - Sydney
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Recruitment hospital [4]
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The Children's Hospital at Westmead - Sydney
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Recruitment hospital [5]
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Westmead Hospital - Sydney
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Recruitment hospital [6]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [7]
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Women's and Children's Hospital - North Adelaide
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Recruitment hospital [8]
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Royal Children's Hospital - Melbourne
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Recruitment hospital [9]
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Epworth Richmond - Melbourne
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Recruitment hospital [10]
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Monash Health- Monash Medical Centre - Melbourne
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Recruitment hospital [11]
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [12]
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Perth Children's Hospital - Perth
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Recruitment hospital [13]
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Sir Charles Gairdner Hospital - Perth
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment postcode(s) [2]
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2031 - Sydney
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Recruitment postcode(s) [3]
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2145 - Sydney
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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5006 - North Adelaide
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Recruitment postcode(s) [6]
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3052 - Melbourne
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Recruitment postcode(s) [7]
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0
3121 - Melbourne
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Recruitment postcode(s) [8]
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3168 - Melbourne
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Recruitment postcode(s) [9]
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6150 - Murdoch
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Recruitment postcode(s) [10]
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6009 - Perth
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Recruitment outside Australia
Country [1]
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Brazil
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State/province [1]
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Amazonas
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Country [2]
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Brazil
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State/province [2]
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Mato Grosso Do Sul
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Country [3]
0
0
Brazil
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State/province [3]
0
0
RJ
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Country [4]
0
0
Netherlands
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State/province [4]
0
0
Alkmaar
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Country [5]
0
0
Netherlands
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State/province [5]
0
0
Arnhem
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Country [6]
0
0
Netherlands
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State/province [6]
0
0
Breda
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Country [7]
0
0
Netherlands
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State/province [7]
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0
Nieuwegein
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Country [8]
0
0
Netherlands
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State/province [8]
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0
Nijmegen
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Country [9]
0
0
Netherlands
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State/province [9]
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0
Utrecht
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Country [10]
0
0
Spain
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State/province [10]
0
0
Barcelona
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Country [11]
0
0
Spain
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State/province [11]
0
0
Bizkaia
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Country [12]
0
0
Spain
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State/province [12]
0
0
Santander
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Country [13]
0
0
Spain
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State/province [13]
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0
Sevilla
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Country [14]
0
0
United Kingdom
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State/province [14]
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0
Devon
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Country [15]
0
0
United Kingdom
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State/province [15]
0
0
Exeter
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Funding & Sponsors
Primary sponsor type
Other
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Name
Murdoch Childrens Research Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Royal Children's Hospital
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Address [1]
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0
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Country [1]
0
0
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Other collaborator category [2]
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Other
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Name [2]
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Bill and Melinda Gates Foundation
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Address [2]
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0
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Country [2]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT04327206
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Trial related presentations / publications
Pittet LF, Messina NL, Gardiner K, Orsini F, Abruzzo V, Bannister S, Bonten M, Campbell JL, Croda J, Dalcolmo M, Elia S, Germano S, Goodall C, Gwee A, Jamieson T, Jardim B, Kollmann TR, Guimaraes Lacerda MV, Lee KJ, Legge D, Lucas M, Lynn DJ, McDonald E, Manning L, Munns CF, Perrett KP, Prat Aymerich C, Richmond P, Shann F, Sudbury E, Villanueva P, Wood NJ, Lieschke K, Subbarao K, Davidson A, Curtis N; BRACE trial Consortium Group. BCG vaccination to reduce the impact of COVID-19 in healthcare workers: Protocol for a randomised controlled trial (BRACE trial). BMJ Open. 2021 Oct 28;11(10):e052101. doi: 10.1136/bmjopen-2021-052101. Crisan-Dabija R, Grigorescu C, Pavel CA, Artene B, Popa IV, Cernomaz A, Burlacu A. Tuberculosis and COVID-19: Lessons from the Past Viral Outbreaks and Possible Future Outcomes. Can Respir J. 2020 Sep 5;2020:1401053. doi: 10.1155/2020/1401053. eCollection 2020.
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Public notes
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Contacts
Principal investigator
Name
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Prof Nigel Curtis
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Address
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Murdoch Children's Research Institute
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Country
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Phone
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Fax
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0
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Email
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0
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Contact person for public queries
Name
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Address
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0
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Country
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Under the terms of the funding agreement with the Bill and Melinda Gates foundation, the BRACE trial has a data sharing agreement in place.
An anonymised Individual Participant Data (IPD) dataset and a data dictionary will be provided to Vivli (https://vivli.org/) under the terms of the agreements with the Bill and Melinda Gates foundation grant and Vivli.
After database lock, the following may be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions, under a collaborator agreement, for accessing:
* Individual participant data that underlie the results reported in our articles after deidentification (text, tables, figures and appendices)
* Study protocol, Statistical Analysis Plan, PICF
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
Query!
When will data be available (start and end dates)?
After database lock, a 12-month embargo period will be in place, to allow adequate time for analyses and publication outputs. Data transfer to Vivli should occur during the embargo period.
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Available to whom?
Researchers from a recognised research institution can approach MCRI for access of data.
The researcher will need to provide evidence that the proposed use of the data has been ethically reviewed and approved by an Institutional Review Board (IRB)/ Human Research Ethics Committee(HREC), and accept MCRI's conditions, under a collaborator agreement.
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04327206