COVID-19 Clinical Trial
— BRACEOfficial title:
BCG Vaccination to Reduce the Impact of COVID-19 in Healthcare Workers (BRACE) Trial
Verified date | August 2022 |
Source | Murdoch Childrens Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 6828 |
Est. completion date | May 27, 2022 |
Est. primary completion date | November 10, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Australia | Epworth Richmond | Melbourne | Victoria |
Australia | Monash Health- Monash Medical Centre | Melbourne | Victoria |
Australia | Royal Children's Hospital | Melbourne | Victoria |
Australia | Fiona Stanley Hospital | Murdoch | Western Australia |
Australia | Women's and Children's Hospital | North Adelaide | South Australia |
Australia | Perth Children's Hospital | Perth | Western Australia |
Australia | Sir Charles Gairdner Hospital | Perth | Western Australia |
Australia | Prince of Wales Hospital | Sydney | New South Wales |
Australia | St Vincent's Hospital, Sydney | Sydney | New South Wales |
Australia | Sydney Children's Hospital, Randwick | Sydney | New South Wales |
Australia | The Children's Hospital at Westmead | Sydney | New South Wales |
Australia | Westmead Hospital | Sydney | New South Wales |
Brazil | CASSEMS Hospital | Campo Grande | Mato Grosso Do Sul |
Brazil | Federal University of Mato Grosso do Sul | Campo Grande | Mato Grosso Do Sul |
Brazil | Hospital Regional de Mato Grosso do Sul | Campo Grande | Mato Grosso Do Sul |
Brazil | Santa Casa Hospital | Campo Grande | Mato Grosso Do Sul |
Brazil | Fundação de Medicina Tropical Dr Heitor Vieira Dourado (FMT-HVD) | Manaus | Amazonas |
Brazil | Centro de Estudos da Saúde do Trabalhador e Ecologia Humana | Rio de Janeiro | RJ |
Brazil | Centro de Referência Prof Hélio Fraga | Rio de Janeiro | RJ |
Netherlands | Noord West Ziekenhuis | Alkmaar | |
Netherlands | Rijnstate Hospital | Arnhem | |
Netherlands | Amphia Hospital | Breda | |
Netherlands | St Antonius Hospital | Nieuwegein | |
Netherlands | Radboud UMC | Nijmegen | |
Netherlands | University hospital in Utrecht (UMCU) | Utrecht | |
Spain | University Hospital German Trias I Pujol | Badalona | Barcelona |
Spain | University Hospital Cruces | Barakaldo | Bizkaia |
Spain | Marqués de Valdecilla University Hospital | Santander | |
Spain | University Hospital Virgen Macarena | Sevilla | |
Spain | Mutua Terrassa Univeristy Hospital | Terrassa | Barcelona |
United Kingdom | Ide Lane Surgery | Alphington | Exeter |
United Kingdom | Royal Devon and Exeter NHS Foundation Trust | Exeter | |
United Kingdom | Travel Clinic | Exeter | |
United Kingdom | St Leonard's Practice | St Leonards | Exeter |
United Kingdom | Teign Estuary Medical Group | Teignmouth | Devon |
Lead Sponsor | Collaborator |
---|---|
Murdoch Childrens Research Institute | Bill and Melinda Gates Foundation, Royal Children's Hospital |
Australia, Brazil, Netherlands, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptomatic COVID-19 by 6 months | 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) |
Measured over the 6 months following randomisation | |
Primary | Severe COVID-19 incidence over 6 months | 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" |
Measured over the 6 months following randomisation | |
Secondary | Symptomatic COVID-19 by 12 months | 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) |
Measured over the 12 months following randomisation | |
Secondary | Severe COVID-19 incidence over 12 months | 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" |
Measured over the 12 months following randomisation | |
Secondary | Time to first symptom of COVID-19 | 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] |
Measured over the 6 and 12 months following randomisation | |
Secondary | Number of Episodes of COVID-19 | The total number of symptomatic or severe COVID-19 episodes (refer to outcome 3 and 4 for definitions) | Measured over the 6 and 12 months following randomisation | |
Secondary | Asymptomatic SARS-CoV-2 infection | 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 |
Measured over the 6 and 12 months following randomisation | |
Secondary | Work absenteeism due to COVID-19 | 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) |
Measured within 6 and 12 months following randomisation | |
Secondary | Bed confinement due to COVID-19 | 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) |
Measured over 6 and 12 months following randomisation | |
Secondary | Symptom duration of COVID-19 | 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) |
Measured over 6 and12 months following randomisation | |
Secondary | Pneumonia due to COVID-19 | Number of pneumonia cases (using self-reported questionnaire and/or medical/hospital records) due to COVID-19 | Measured over the 6 and 12 months following randomisation | |
Secondary | Oxygen therapy due to COVID-19 | Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records) due to COVID-19 | Measured over the 6 and12 months following randomisation | |
Secondary | Critical care admissions due to COVID-19 | Number of admission to critical care (using self-reported questionnaire and/or medical/hospital records) due to COVID-19 | Measured over the 6 and 12 months following randomisation | |
Secondary | Mechanical ventilation due to COVID-19 | Number of participants needing mechanical ventilation (using self-reported questionnaire and/or medical/hospital records) | Measured over the 12 months following randomisation | |
Secondary | Hospitalisation duration with COVID-19 | Number of days of hospitalisation due to COVID-19 (using self-reported questionnaire and/or medical/hospital records). | Measured over the 6 and 12 months following randomisation | |
Secondary | Mortality due to COVID-19 | Number of deaths due to COVID-19 | Measured over the 6 and 12 months following randomisation | |
Secondary | Fever or respiratory illness | 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). |
Measured over the 12 months following randomisation | |
Secondary | Severe fever or respiratory illness | 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 |
Measured over the 12 months following randomisation | |
Secondary | Episodes of fever or respiratory illness | 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). |
Measured over the 12 months following randomisation | |
Secondary | Work absenteeism due to fever or respiratory illness | 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) |
Measured over the 12 months following randomisation | |
Secondary | Bed confinement due to fever or respiratory illness | 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) |
Measured over the 12 months following randomisation | |
Secondary | Symptom duration of fever or respiratory illness | 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) |
Measured over the 12 months following randomisation | |
Secondary | Pneumonia within a febrile or respiratory illness | Number of pneumonia cases(using self-reported questionnaire and/or medical/hospital records) | Measured over the 12 months following randomisation | |
Secondary | Oxygen therapy for a febrile or respiratory illness | Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records) | Measured over the 12 months following randomisation | |
Secondary | Critical care admissions for a febrile or respiratory illness | Number of admission to critical care (using self-reported questionnaire and/or medical/hospital records) | Measured over the 12 months following randomisation | |
Secondary | Mechanical ventilation for a febrile or respiratory illness | Number of participants needing mechanical ventilation (using self-reported questionnaire and/or medical/hospital records) | Measured over the 12 months following randomisation | |
Secondary | Mortality as a consequence of an episode of fever or respiratory illness | Number of deaths | Measured over the 12 months following randomisation | |
Secondary | Hospitalisation duration for a febrile or respiratory illness | Number of days of hospitalisation due to fever or respiratory illness (using self-reported questionnaire, medical/hospital records) | Measured within 6 and 12 months following randomisation | |
Secondary | Unplanned work absenteeism for an acute illness or hospitalisation | Number of days of unplanned absenteeism for any reason (using self-reported questionnaire) | Measured over the 6 and 12 months following randomisation | |
Secondary | Local and systemic adverse events to BCG vaccination in healthcare workers | 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. | Measured over the 3 months following randomisation | |
Secondary | Serious Adverse Events (SAEs) to BCG vaccination in healthcare workers | SAEs over the 3 months following randomisation, by type, severity (graded using toxicity grading scale), relationship to intervention. | Measured over the 3 months following randomisation |
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