COVID-19Phase 3NCT04379336
BCG Vaccination for Healthcare Workers in COVID-19 Pandemic
A Phase 3 study testing Bacille Calmette-Guérin (BCG) in people with COVID-19 and Sars-CoV2, run by TASK Applied Science at 1 site in South Africa.
Trial summary
A novel betacoronavirus, SARS-CoV-2, is spreading rapidly throughout the world. A large epidemic in South Africa may overwhelm available hospital capacity and healthcare resources which would be worsened by absenteeism of healthcare workers and other frontline staff (HCW). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Bacille Calmette-Guérin (BCG)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteSouth Africa
- Study dates
- 4 May 2020to 2 Jan 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
- Men and women aged ≥18 years
- HCW or other frontline staff currently in contact with, or anticipated to be in contact with, patients with SARS-CoV-2 infection.
- Ability and willingness to provide informed consent.
- Can be reached by mobile phone for follow-up
Who cannot join
- Known allergy to (components of) the BCG vaccine or serious reaction to prior BCG administration.
- Known active tuberculosis or any other active or uncontrolled condition that, in the opinion of the investigator or designee, makes participation unsafe or makes it difficult to collect follow-up data over the study period.
- HIV-1 infection
- NOTE: If evidence of recent HIV negative test is not available, rapid point-of-care testing will be undertaken as part of screening with a separate informed consent process.
- Symptoms of respiratory tract infection which, in the opinion of the investigator or designee, is likely to interfere with the objectives of the study.
- Known medical history of any of the following immunocompromised states:
Show all 17Show fewer
- Neutropenia (less than 500 neutrophils/mm3)
- Lymphopenia (less than 400 lymphocytes/mm3)
- Solid organ or bone marrow transplantation
- Primary immunodeficiency
- Active solid or non-solid malignancy or lymphoma within the prior two years
- Pregnancy and breastfeeding
- Current treatment with the following medications:
- Chemotherapy
- Anti-cytokine therapies
- Current treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months
- Any experimental, unproven treatment against SARS-CoV-2 infection or COVID-19 including but not limited to chloroquine, hydroxychloroquine, remdesivir, lopinavir/ritonavir and interferon beta-1a.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Morbidity and Mortality in Health Care Workers Exposed to SARS-CoV-2 by Enhancing Non-specific Immune Responses Through Bacillus Calmette-Guérin Vaccination, a Randomized Controlled Trial
A novel betacoronavirus, SARS-CoV-2, is spreading rapidly throughout the world. A large epidemic in South Africa may overwhelm available hospital capacity and healthcare resources which would be worsened by absenteeism of healthcare workers and other frontline staff (HCW). Strategies to prevent morbidity and mortality of HCW are desperately needed to safeguard continuous patient care. Bacillus Calmette-Guérin (BCG) is a vaccine against tuberculosis (TB), with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, with reported morbidity and mortality reductions as high as 70%. We hypothesize that a BCG vaccination may reduce the morbidity and mortality of healthcare workers during the COVID-19 outbreak in South Africa.
Read the detailed description
Morbidity and mortality attributable to COVID-19 is devastating global health systems and economies. Bacillus Calmette Guérin (BCG) vaccination has been in use for many decades to prevent severe forms of tuberculosis in children. Studies have also shown a combination of improved long-term innate or trained immunity (through epigenetic reprogramming of myeloid cells) and adaptive responses after BCG vaccination, which leads to non-specific protective effects in adults. Observational studies have shown that countries with routine BCG vaccination programs have significantly less reported cases and deaths of COVID-19, but such studies are prone to significant bias and need confirmation. To date, in the absence of direct evidence, WHO does not recommend BCG for the prevention of COVID-19.
This project aims to investigate in a timely manner whether and why BCG-revaccination can reduce infection rate and/or disease severity in health care workers during the SARS-CoV-2 outbreak in South Africa. These objectives will be achieved with a blinded, randomised controlled trial of BCG revaccination versus placebo in exposed front-line staff in hospitals in Cape Town. Observations will include the rate of infection with COVID-19 as well as the occurrence of mild, moderate or severe ambulatory respiratory tract infections, hospitalisation, need for oxygen, mechanical ventilation or death. HIV-positive individuals will be excluded. Safety of the vaccines will be monitored. A secondary endpoint is the occurrence of latent or active tuberculosis. Initial sample size and follow-up duration is at least 500 workers and 52 weeks. Statistical analysis will be model-based and ongoing in real time with frequent interim analyses and optional increases of both sample size or observation time, based on the unforeseeable trajectory of the South African COVID-19 epidemic, available funds and recommendations of an independent data and safety monitoring board.
Given the immediate threat of the SARS-CoV-2 epidemic the trial has been designed as a pragmatic study with highly feasible endpoints that can be continuously measured. This allows for the most rapid identification of a beneficial outcome that would lead to immediate dissemination of the results, vaccination of the control group and outreach to the health authorities to consider BCG vaccination for all qualifying health care workers.
- Being tested
- Bacille Calmette-Guérin (BCG), Placebo Comparator
- Keywords
- Blinded, Randomized controlled, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacille Calmette-Guérin (BCG)Biological
Also called BCG-Vaccin SSI [Statens Serum Institut], Danish strain 1331
BCG vaccine will be given intradermally in the upper arm after randomization.
Placebo ComparatorOther
Also called 0.9% Sodium Chloride
Placebo injection will be given intradermally in the upper arm after randomization.
| Study group | Role | What they receive |
|---|---|---|
| Bacille Calmette-Guérin (BCG) | Experimental | Participants will receive an intradermal injection of 0.1ml of the suspended BCG vaccine which accounts for 0.075mg of attenuated Mycobacterium bovis. BCG-Vaccin SSI [Statens Serum Institut], Danish strain 1331. Receives: Biological: Bacille Calmette-Guérin (BCG) |
| Placebo | Placebo comparator | The placebo used for this study is 0.9% Sodium Chloride (NaCl). Participants that are randomized to the control arm will receive a placebo injection of 0.1ml 0.9% NaCl, which is the same volume and has the same colour as the suspended BCG vaccine. Receives: Other: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of HCWs hospitalized due to COVID-19 per arm
To compare the incidence of HCWs hospitalized due to COVID-19 per arm.
Measured: 52 weeks
Secondary outcomes (10)
Incidence of SARS-CoV-2 infection per arm
To determine the incidence of SARS-CoV-2 infection in HCW by molecular or serological testing (as available) at entry, 10, 26 and/or 52 weeks.
Measured: 52 weeks
Incidence of upper respiratory tract infections per arm
To compare the incidence of symptoms of upper respiratory tract infection per arm.
Measured: 52 weeks
Days of unplanned absenteeism due to COVID-19 or any reason per arm
To compare the number of days of (unplanned) absenteeism because of documented SARS-CoV-2 infection, COVID-19 or any reason per arm.
Measured: 52 weeks
Incidence of hospitalization for any reason per arm
To compare the incidence of hospitalization of HCW for any reason per arm.
Measured: 52 weeks
Incidence of intensive care unit admission per arm
To compare the incidence of intensive care admission of HCW due to COVID-19 or any reason per arm.
Measured: 52 weeks
Incidence of death per arm
To compare the incidence of death of HCW due to COVID-19 or any reason per arm.
Measured: 52 weeks
Prevalence of latent TB infection
To describe the prevalence of latent TB infection as determined by interferon gamma release assay (IGRA) at enrolment and at week 52.
Measured: 52 weeks
Incidence of active TB per arm
To compare the incidence of active TB of HCW per arm.
Measured: 52 weeks
Compare the effect of latent TB on morbidity and mortality due to COVID-19 per arm
To compare the effect of latent TB infection on morbidity and mortality of HCW due to COVID-19 per arm. The risk of morbidity and mortality of latent TB infected individuals is not known, we will examine whether there is a higher risk of disease severity and poor outcomes in this group.
Measured: 52 weeks
Incidence of treatment related adverse events
To compare the incidence of grade 2 or higher adverse events and vaccination site reactions per arm.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start4 May 2020
- Primary completion2 Jan 2022
- Study completion2 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Efficacy will be determined based on documented SARS-CoV-2 infection and incidence of hospitalization. The analysis will be an intention-to-treat analysis with estimation of hazard ratio between the two arms using a Cox proportional hazard model. Adverse events will be summarized using descriptive statistics per study arm. The analysis will be a model-based analysis of cumulative data on general health status as a function of risk factors, treatment arm and time.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- TASK Applied Science
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379336
- Sponsor's protocol ID
- TASK-008 BCG-CORONA
- Status last verified
- Oct 2021
- First submitted
- 4 May 2020
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will only be shared among researchers included in the protocol team at this stage.
Publications
Netea MG, Schlitzer A, Placek K, Joosten LAB, Schultze JL. Innate and Adaptive Immune Memory: an Evolutionary Continuum in the Host's Response to Pathogens. Cell Host Microbe. 2019 Jan 9;25(1):13-26. doi: 10.1016/j.chom.2018.12.006.
PubMed 30629914Kleinnijenhuis J, Quintin J, Preijers F, Joosten LA, Ifrim DC, Saeed S, Jacobs C, van Loenhout J, de Jong D, Stunnenberg HG, Xavier RJ, van der Meer JW, van Crevel R, Netea MG. Bacille Calmette-Guerin induces NOD2-dependent nonspecific protection from reinfection via epigenetic reprogramming of monocytes. Proc Natl Acad Sci U S A. 2012 Oct 23;109(43):17537-42. doi: 10.1073/pnas.1202870109. Epub 2012 Sep 17.
PubMed 22988082van Wijk RC, Mockeliunas L, Upton CM, Peter J, Diacon AH, Simonsson USH. Seasonal influence on respiratory tract infection severity including COVID-19 quantified through Markov Chain modeling. CPT Pharmacometrics Syst Pharmacol. 2023 Sep;12(9):1250-1261. doi: 10.1002/psp4.13006. Epub 2023 Jul 10.
PubMed 37401774Upton CM, van Wijk RC, Mockeliunas L, Simonsson USH, McHarry K, van den Hoogen G, Muller C, von Delft A, van der Westhuizen HM, van Crevel R, Walzl G, Baptista PM, Peter J, Diacon AH; BCG CORONA Consortium. Safety and efficacy of BCG re-vaccination in relation to COVID-19 morbidity in healthcare workers: A double-blind, randomised, controlled, phase 3 trial. EClinicalMedicine. 2022 Jun;48:101414. doi: 10.1016/j.eclinm.2022.101414. Epub 2022 May 12.
PubMed 35582122
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Morbidity and Mortality in Health Care Workers Exposed to SARS-CoV-2 by Enhancing Non-specific Immune Responses Through Bacillus Calmette-Guérin Vaccination, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04379336
- Acronym / sponsor ID
- TASK-008 BCG-CORONA
- Keywords
- Blinded, Randomized controlled, SARS-CoV-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- TASK Applied ScienceUniversity, hospital or other
- Study start
- 4 May 2020 (actual)
- Primary completion
- 2 Jan 2022 (actual)
- Study completion
- 2 Jan 2022 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A novel betacoronavirus, SARS-CoV-2, is spreading rapidly throughout the world. A large epidemic in South Africa may overwhelm available hospital capacity and healthcare resources which would be worsened by absenteeism of healthcare workers and other frontline staff (HCW). Strategies to prevent morbidity and mortality of HCW are desperately needed to safeguard continuous patient care. Bacillus Calmette-Guérin (BCG) is a vaccine against tuberculosis (TB), with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, with reported morbidity and mortality reductions as high as 70%. We hypothesize that a BCG vaccination may reduce the morbidity and mortality of healthcare workers during the COVID-19 outbreak in South Africa.
Detailed description
Morbidity and mortality attributable to COVID-19 is devastating global health systems and economies. Bacillus Calmette Guérin (BCG) vaccination has been in use for many decades to prevent severe forms of tuberculosis in children. Studies have also shown a combination of improved long-term innate or trained immunity (through epigenetic reprogramming of myeloid cells) and adaptive responses after BCG vaccination, which leads to non-specific protective effects in adults. Observational studies have shown that countries with routine BCG vaccination programs have significantly less reported cases and deaths of COVID-19, but such studies are prone to significant bias and need confirmation. To date, in the absence of direct evidence, WHO does not recommend BCG for the prevention of COVID-19.
This project aims to investigate in a timely manner whether and why BCG-revaccination can reduce infection rate and/or disease severity in health care workers during the SARS-CoV-2 outbreak in South Africa. These objectives will be achieved with a blinded, randomised controlled trial of BCG revaccination versus placebo in exposed front-line staff in hospitals in Cape Town. Observations will include the rate of infection with COVID-19 as well as the occurrence of mild, moderate or severe ambulatory respiratory tract infections, hospitalisation, need for oxygen, mechanical ventilation or death. HIV-positive individuals will be excluded. Safety of the vaccines will be monitored. A secondary endpoint is the occurrence of latent or active tuberculosis. Initial sample size and follow-up duration is at least 500 workers and 52 weeks. Statistical analysis will be model-based and ongoing in real time with frequent interim analyses and optional increases of both sample size or observation time, based on the unforeseeable trajectory of the South African COVID-19 epidemic, available funds and recommendations of an independent data and safety monitoring board.
Given the immediate threat of the SARS-CoV-2 epidemic the trial has been designed as a pragmatic study with highly feasible endpoints that can be continuously measured. This allows for the most rapid identification of a beneficial outcome that would lead to immediate dissemination of the results, vaccination of the control group and outreach to the health authorities to consider BCG vaccination for all qualifying health care workers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Efficacy will be determined based on documented SARS-CoV-2 infection and incidence of hospitalization. The analysis will be an intention-to-treat analysis with estimation of hazard ratio between the two arms using a Cox proportional hazard model. Adverse events will be summarized using descriptive statistics per study arm. The analysis will be a model-based analysis of cumulative data on general health status as a function of risk factors, treatment arm and time.
| Arm | Type | Receives |
|---|---|---|
| Bacille Calmette-Guérin (BCG) | Experimental | Biological: Bacille Calmette-Guérin (BCG)Participants will receive an intradermal injection of 0.1ml of the suspended BCG vaccine which accounts for 0.075mg of attenuated Mycobacterium bovis. BCG-Vaccin SSI [Statens Serum Institut], Danish strain 1331. |
| Placebo | Placebo comparator | Other: Placebo ComparatorThe placebo used for this study is 0.9% Sodium Chloride (NaCl). Participants that are randomized to the control arm will receive a placebo injection of 0.1ml 0.9% NaCl, which is the same volume and has the same colour as the suspended BCG vaccine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged ≥18 years
- HCW or other frontline staff currently in contact with, or anticipated to be in contact with, patients with SARS-CoV-2 infection.
- Ability and willingness to provide informed consent.
- Can be reached by mobile phone for follow-up
Key exclusion criteria (17 listed)
- Known allergy to (components of) the BCG vaccine or serious reaction to prior BCG administration.
- Known active tuberculosis or any other active or uncontrolled condition that, in the opinion of the investigator or designee, makes participation unsafe or makes it difficult to collect follow-up data over the study period.
- HIV-1 infection
- Symptoms of respiratory tract infection which, in the opinion of the investigator or designee, is likely to interfere with the objectives of the study.
- Known medical history of any of the following immunocompromised states:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacille Calmette-Guérin (BCG)Also: BCG-Vaccin SSI [Statens Serum Institut], Danish strain 1331BCG vaccine will be given intradermally in the upper arm after randomization. | Biological | Bacille Calmette-Guérin (BCG) |
| Placebo ComparatorAlso: 0.9% Sodium ChloridePlacebo injection will be given intradermally in the upper arm after randomization. | Other | Placebo |
Primary outcome
Incidence of HCWs hospitalized due to COVID-19 per arm
Time frame: 52 weeks
To compare the incidence of HCWs hospitalized due to COVID-19 per arm.
10 secondary outcomes
Incidence of SARS-CoV-2 infection per arm
Time frame: 52 weeks
Incidence of upper respiratory tract infections per arm
Time frame: 52 weeks
Days of unplanned absenteeism due to COVID-19 or any reason per arm
Time frame: 52 weeks
Incidence of hospitalization for any reason per arm
Time frame: 52 weeks
Incidence of intensive care unit admission per arm
Time frame: 52 weeks
Incidence of death per arm
Time frame: 52 weeks
Prevalence of latent TB infection
Time frame: 52 weeks
Incidence of active TB per arm
Time frame: 52 weeks
Compare the effect of latent TB on morbidity and mortality due to COVID-19 per arm
Time frame: 52 weeks
Incidence of treatment related adverse events
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Background: PubMed 30629914Netea MG, Schlitzer A, Placek K, Joosten LAB, Schultze JL. Innate and Adaptive Immune Memory: an Evolutionary Continuum in the Host's Response to Pathogens. Cell Host Microbe. 2019 Jan 9;25(1):13-26. doi: 10.1016/j.chom.2018.12.006.
- Background: PubMed 22988082Kleinnijenhuis J, Quintin J, Preijers F, Joosten LA, Ifrim DC, Saeed S, Jacobs C, van Loenhout J, de Jong D, Stunnenberg HG, Xavier RJ, van der Meer JW, van Crevel R, Netea MG. Bacille Calmette-Guerin induces NOD2-dependent nonspecific protection from reinfection via epigenetic reprogramming of monocytes. Proc Natl Acad Sci U S A. 2012 Oct 23;109(43):17537-42. doi: 10.1073/pnas.1202870109. Epub 2012 Sep 17.
- Derived from this study: PubMed 37401774van Wijk RC, Mockeliunas L, Upton CM, Peter J, Diacon AH, Simonsson USH. Seasonal influence on respiratory tract infection severity including COVID-19 quantified through Markov Chain modeling. CPT Pharmacometrics Syst Pharmacol. 2023 Sep;12(9):1250-1261. doi: 10.1002/psp4.13006. Epub 2023 Jul 10.
- Derived from this study: PubMed 35582122Upton CM, van Wijk RC, Mockeliunas L, Simonsson USH, McHarry K, van den Hoogen G, Muller C, von Delft A, van der Westhuizen HM, van Crevel R, Walzl G, Baptista PM, Peter J, Diacon AH; BCG CORONA Consortium. Safety and efficacy of BCG re-vaccination in relation to COVID-19 morbidity in healthcare workers: A double-blind, randomised, controlled, phase 3 trial. EClinicalMedicine. 2022 Jun;48:101414. doi: 10.1016/j.eclinm.2022.101414. Epub 2022 May 12.
- Individual participant dataSharing planned: No. IPD will only be shared among researchers included in the protocol team at this stage.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bacille Calmette-Guérin (BCG) in people with COVID-19 and Sars-CoV2, run by TASK Applied Science at 1 site in South Africa.
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 4 inclusion and 17 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 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. 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?
Incidence of HCWs hospitalized due to COVID-19 per arm (time frame: 52 weeks). 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 NCT04379336, which also lists 4 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 25 Jan 2022.