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Coronavirus Disease 2019 (COVID-19)Phase 3BRACENCT04327206

BCG Vaccination to Protect Healthcare Workers Against COVID-19

A Phase 3 study testing BCG Vaccine and 0.9%NaCl in people with Coronavirus Disease 2019 (COVID-19) and Respiratory Illness, run by Murdoch Childrens Research Institute at 36 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
BCG Vaccine and 0.9%NaCl
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6,828 participants
Where
36 sitesin 5 countries
Study dates
30 Mar 2020to 27 May 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 29Show fewer
  • 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

Trial locations and contacts

36 sites in 5 countries.

36 sites in 5 countries

Australia13 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Royal Children's Hospital

    Melbourne, Victoria, 3052

  • Epworth Richmond

    Melbourne, Victoria, 3121

  • Monash Health- Monash Medical Centre

    Melbourne, Victoria, 3168

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Women's and Children's Hospital

    North Adelaide, South Australia, 5006

  • Perth Children's Hospital

    Perth, Western Australia, 6009

  • Sir Charles Gairdner Hospital

    Perth, Western Australia, 6009

  • St Vincent's Hospital, Sydney

    Sydney, New South Wales, 2010

  • Prince of Wales Hospital

    Sydney, New South Wales, 2031

  • Sydney Children's Hospital, Randwick

    Sydney, New South Wales, 2145

  • The Children's Hospital at Westmead

    Sydney, New South Wales, 2145

  • Westmead Hospital

    Sydney, New South Wales, 2145

Other trials in Australia

Brazil7 sites

  • Santa Casa Hospital

    Campo Grande, Mato Grosso do Sul, 79002-230

  • CASSEMS Hospital

    Campo Grande, Mato Grosso do Sul, 79002-251

  • Federal University of Mato Grosso do Sul

    Campo Grande, Mato Grosso do Sul, 79070-900

  • Hospital Regional de Mato Grosso do Sul

    Campo Grande, Mato Grosso do Sul, 79084-180

  • Fundação de Medicina Tropical Dr Heitor Vieira Dourado (FMT-HVD)

    Manaus, Amazonas, 69040-000

  • Centro de Estudos da Saúde do Trabalhador e Ecologia Humana

    Rio de Janeiro, Rio de Janeiro, 22780-195

  • Centro de Referência Prof Hélio Fraga

    Rio de Janeiro, Rio de Janeiro, 22780-195

Other trials in Brazil

Netherlands6 sites

  • Noord West Ziekenhuis

    Alkmaar, 1815 JD

  • Rijnstate Hospital

    Arnhem, 6815 AD

  • Amphia Hospital

    Breda, 4818 CK

  • St Antonius Hospital

    Nieuwegein, 3435 CM

  • Radboud UMC

    Nijmegen, 6525 GA

  • University hospital in Utrecht (UMCU)

    Utrecht, 3584 CX

Other trials in Netherlands

Spain5 sites

  • University Hospital German Trias I Pujol

    Badalona, Barcelona, 08916

  • University Hospital Cruces

    Barakaldo, Bizkaia, 48903

  • Marqués de Valdecilla University Hospital

    Santander, 39008

  • University Hospital Virgen Macarena

    Seville, 41009

  • Mutua Terrassa Univeristy Hospital

    Terrassa, Barcelona, 08221

Other trials in Spain

United Kingdom5 sites

  • Ide Lane Surgery

    Alphington, Exeter, EX2 8UP

  • Travel Clinic

    Exeter, Exeter, EX1 1PR

  • Royal Devon and Exeter NHS Foundation Trust

    Exeter, EX2 5DW

  • St Leonard's Practice

    St Leonards, Exeter, EX1 1SB

  • Teign Estuary Medical Group

    Teignmouth, Devon, TQ14 8AB

Other trials in United Kingdom

About this study

Official title: BCG Vaccination to Reduce the Impact of COVID-19 in Healthcare Workers (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.

Read the detailed description

Healthcare workers are at the frontline of the coronavirus disease (COVID-19) pandemic. They will be randomised to receive a single dose of BCG vaccine or 0.9% NaCl placebo. Participants will be followed-up for 12 months with notification from a Smartphone application or phone calls (up to daily when ill) and surveys to identify and detail COVID-19 infection. Additional information on severe disease will be obtained from hospital medical records and/or government databases. Blood samples will be collected prior to randomisation and at 3, 6, 9 and 12 months to determine exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Where required, swab/blood samples will be taken at illness episodes to assess SARS-CoV-2 infection.

The trial includes a pre-planned meta-analysis with data from 2834 participants recruited in the Stage 1 of this study, where participants were randomised to receive BCG or no BCG vaccine at the time of receiving influenza vaccination.

Being tested
BCG Vaccine, 0.9%NaCl
Medical subject headings
COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCG VaccineDrug

    Also called Bacille Calmette-Guerin Vaccine, Bacillus Calmette-Guerin Vaccine, Statens Serum Institute BCG vaccine, Mycobacterium bovis BCG (Bacille Calmette Guérin), Danish Strain 1331

    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

  • 0.9%NaClDrug

    Also called 0.9% Saline

    0.9% Sodium Chloride Injection

Study groups in NCT04327206
Study groupRoleWhat they receive
BCG vaccineExperimentalParticipants 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).
Receives: Drug: BCG Vaccine
0.9% SalinePlacebo comparatorParticipants 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).
Receives: Drug: 0.9%NaCl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: Measured over the 6 months following randomisation

  2. 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: Measured over the 6 months following randomisation

Secondary outcomes (29)

  1. 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: Measured over the 12 months following randomisation

  2. 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: Measured over the 12 months following randomisation

  3. 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: Measured over the 6 and 12 months following randomisation

  4. 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: Measured over the 6 and 12 months following randomisation

  5. 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: Measured over the 6 and 12 months following randomisation

  6. 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: Measured within 6 and 12 months following randomisation

  7. 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: Measured over 6 and 12 months following randomisation

  8. 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: Measured over 6 and12 months following randomisation

  9. Pneumonia due to COVID-19

    Number of pneumonia cases (using self-reported questionnaire and/or medical/hospital records) due to COVID-19

    Measured: Measured over the 6 and 12 months following randomisation

  10. Oxygen therapy due to COVID-19

    Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records) due to COVID-19

    Measured: Measured over the 6 and12 months following randomisation

  11. 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: Measured over the 6 and 12 months following randomisation

  12. Mechanical ventilation due to COVID-19

    Number of participants needing mechanical ventilation (using self-reported questionnaire and/or medical/hospital records)

    Measured: Measured over the 12 months following randomisation

  13. Hospitalisation duration with COVID-19

    Number of days of hospitalisation due to COVID-19 (using self-reported questionnaire and/or medical/hospital records).

    Measured: Measured over the 6 and 12 months following randomisation

  14. Mortality due to COVID-19

    Number of deaths due to COVID-19

    Measured: Measured over the 6 and 12 months following randomisation

  15. 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: Measured over the 12 months following randomisation

  16. 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: Measured over the 12 months following randomisation

  17. 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: Measured over the 12 months following randomisation

  18. 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: Measured over the 12 months following randomisation

  19. 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: Measured over the 12 months following randomisation

  20. 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: Measured over the 12 months following randomisation

  21. Pneumonia within a febrile or respiratory illness

    Number of pneumonia cases(using self-reported questionnaire and/or medical/hospital records)

    Measured: Measured over the 12 months following randomisation

  22. Oxygen therapy for a febrile or respiratory illness

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

    Measured: Measured over the 12 months following randomisation

  23. 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: Measured over the 12 months following randomisation

  24. Mechanical ventilation for a febrile or respiratory illness

    Number of participants needing mechanical ventilation (using self-reported questionnaire and/or medical/hospital records)

    Measured: Measured over the 12 months following randomisation

  25. Mortality as a consequence of an episode of fever or respiratory illness

    Number of deaths

    Measured: Measured over the 12 months following randomisation

  26. 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: Measured within 6 and 12 months following randomisation

  27. Unplanned work absenteeism for an acute illness or hospitalisation

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

    Measured: Measured over the 6 and 12 months following randomisation

  28. 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: Measured over the 3 months following randomisation

  29. 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: Measured over the 3 months following randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2020
  2. Study start30 Mar 2020
  3. Primary completion10 Nov 2021
  4. Study completion27 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase III, two group, multicentre, randomised controlled trial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
6,828 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04327206
Sponsor's protocol ID
62586
Other IDs
U1111-1256-4104, INV-017302
Acronym
BRACE
Status last verified
Jul 2024
First submitted
25 Mar 2020
Last updated
19 Sep 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • McDonald E, Pittet LF, Bonten M, Byrne A, Campbell J, Croda J, Dalcolmo M, Davidson AJ, Dos Santos G, Gardiner K, Gwee A, Jardim B, Lacerda M, Lucas M, Lynn DJ, Manning L, Marshall H, Perrett KP, Prat-Aymerich C, Puga MAM, Richmond P, Rodriguez-Bano J, Wadia U, Warris A, Wood N, Curtis N, Messina NL; BRACE Trial Consortium Group. Optimising COVID-19 episode identification using serology and PCR/rapid antigen testing: insights from the BRACE trial. BMC Infect Dis. 2026 Apr 7;26(1):974. doi: 10.1186/s12879-026-13128-6.

    PubMed 41947067

  • Messina NL, Pittet LF, McDonald E, Moore C, Barry S, Bonten M, Byrne A, Campbell J, Croda J, Croda MG, Dalcolmo M, de Almeida E Val FF, de Oliveira RD, Dos Santos G, Douglas MW, Gardiner K, Gwee A, Jardim BA, Kollmann T, Lacerda MV, Lucas M, Lynn DJ, Manning L, Marshall H, O'Connell A, Perrett KP, Post JJ, Prat-Aymerich C, Rocha JL, Rodriguez-Bano J, Wadia U, Warris A, Davidson A, Curtis N; BRACE Trial Consortium Group. BCG vaccination of healthcare workers for protection against COVID-19: 12-month outcomes from an international randomised controlled trial. J Infect. 2024 Oct;89(4):106245. doi: 10.1016/j.jinf.2024.106245. Epub 2024 Aug 8.

    PubMed 39127450

  • Pittet LF, Messina NL, McDonald E, Orsini F, Barry S, Bonten M, Campbell J, Croda J, Croda MG, Dalcolmo M, Gardiner K, Gwee A, Jardim B, Lacerda MVG, Lucas M, Lynn DJ, Manning L, Perrett KP, Post JJ, Prat-Aymerich C, Richmond PC, Rocha JL, Rodriguez-Bano J, Warris A, Wood NJ, Davidson A, Curtis N; BRACE Trial Consortium Group. Bacille Calmette-Guerin vaccination to prevent febrile and respiratory illness in adults (BRACE): secondary outcomes of a randomised controlled phase 3 trial. EClinicalMedicine. 2024 May 13;72:102616. doi: 10.1016/j.eclinm.2024.102616. eCollection 2024 Jun.

    PubMed 38774675

  • Dos Santos PCP, Messina NL, de Oliveira RD, da Silva PV, Puga MAM, Dalcolmo M, Dos Santos G, de Lacerda MVG, Jardim BA, de Almeida E Val FF, Curtis N, Andrews JR, Croda J. Effect of BCG vaccination against Mycobacterium tuberculosis infection in adult Brazilian health-care workers: a nested clinical trial. Lancet Infect Dis. 2024 Jun;24(6):594-601. doi: 10.1016/S1473-3099(23)00818-6. Epub 2024 Feb 26.

    PubMed 38423021

  • Pittet LF, Moore CL, McDonald E, Barry S, Bonten M, Campbell J, Croda J, Dalcolmo M, Davidson A, Douglas MW, Gardiner K, Gwee A, Jardim B, Lacerda MVG, Lucas M, Lynn DJ, Manning L, de Oliveira RD, Perrett KP, Prat-Aymerich C, Richmond PC, Rocha JL, Rodriguez-Bano J, Warris A, Wood NJ, Messina NL, Curtis N; BRACE Trial Consortium Group. Bacillus Calmette-Guerin vaccination for protection against recurrent herpes labialis: a nested randomised controlled trial. EClinicalMedicine. 2023 Sep 11;64:102203. doi: 10.1016/j.eclinm.2023.102203. eCollection 2023 Oct.

    PubMed 37719417

  • Pittet LF, Messina NL, Orsini F, Moore CL, Abruzzo V, Barry S, Bonnici R, Bonten M, Campbell J, Croda J, Dalcolmo M, Gardiner K, Gell G, Germano S, Gomes-Silva A, Goodall C, Gwee A, Jamieson T, Jardim B, Kollmann TR, Lacerda MVG, Lee KJ, Lucas M, Lynn DJ, Manning L, Marshall HS, McDonald E, Munns CF, Nicholson S, O'Connell A, de Oliveira RD, Perlen S, Perrett KP, Prat-Aymerich C, Richmond PC, Rodriguez-Bano J, Dos Santos G, da Silva PV, Teo JW, Villanueva P, Warris A, Wood NJ, Davidson A, Curtis N; BRACE Trial Consortium Group. Randomized Trial of BCG Vaccine to Protect against Covid-19 in Health Care Workers. N Engl J Med. 2023 Apr 27;388(17):1582-1596. doi: 10.1056/NEJMoa2212616.

    PubMed 37099341

  • 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.

    PubMed 34711598

  • 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.

    PubMed 32934758

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BCG Vaccine and 0.9%NaCl in people with Coronavirus Disease 2019 (COVID-19) and Respiratory Illness, run by Murdoch Childrens Research Institute at 36 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Australia, Brazil, Netherlands, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptomatic COVID-19 by 6 months (time frame: Measured over the 6 months following randomisation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04327206, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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