COVID-19Phase 3BCG-CORONANCT04328441
Reducing Health Care Workers Absenteeism in Covid-19 Pandemic Through BCG Vaccine
A Phase 3 study testing BCG Vaccine in people with COVID-19, run by UMC Utrecht at 9 sites in Netherlands.
Trial summary
Rationale: Covid-19 spreads rapidly throughout the world. A large epidemic in the Netherlands would seriously challenge the available hospital capacity, and this would be augmented by absenteeism of healthcare workers (HCW). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- BCG Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,511 participants
- Where
- 9 sitesNetherlands
- Study dates
- 25 Mar 2020to 31 Mar 2021
- 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
- Adult (≥18 years)
- Male or female
- Hospital personnel (expected to) taking care for patients with SARS CoV-2 infection
Who cannot join
- Known allergy to (components of) the BCG vaccine or serious adverse events to prior BCG administration
- Known active or latent Mycobacterium tuberculosis or with another mycobacterial species. A history with- or a suspicion of M. tuberculosis infection.
- Fever (>38 C) within the past 24 hours
- Pregnancy
- Suspicion of active viral or bacterial infection
- Vaccination in the past 4 weeks or expected vaccination during the study period, independent of the type of vaccination.
Show all 12Show fewer
- Severely immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) neutropenic subjects with less than 500 neutrophils/mm3; c) subjects with solid organ transplantation; d) subjects with bone marrow transplantation; e) subjects under chemotherapy; f) subjects with primary immunodeficiency; g) severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any anti-cytokine therapies. i) treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months, or probable use of oral or intravenous steroids in the following four weeks
- Active solid or non-solid malignancy or lymphoma within the prior two years
- Direct involvement in the design or the execution of the BCG-CORONA study
- Expected absence from work of ≥4 of the following 12 weeks due to any reason (holidays, maternity leave, retirement, planned surgery etc)
- Employed to the hospital < 22 hours per week
- Not in possession of a smartphone
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Netherlands9 sites
Jeroen Bosch ziekenhuis
's-Hertogenbosch, North Brabant
Noordwest Ziekenhuisgroep locatie Alkmaar
Alkmaar, North Holland
Leiden University Medical Center
Leiden, South Holland
Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland
Radboud UMC
Nijmegen, Gelderland
Sint Maartenskliniek
Nijmegen, Gelderland
Erasmus Medical Center
Rotterdam, South Holland
Hagaziekenhuis
The Hague, South Holland
University Medical Center Utrecht
Utrecht
About this study
Official title: Reducing Health Care Workers Absenteeism in COVID-19 Pandemic by Enhanced Trained Immune Responses Through Bacillus Calmette-Guérin Vaccination, a Randomized Controlled Trial.
Rationale: Covid-19 spreads rapidly throughout the world. A large epidemic in the Netherlands would seriously challenge the available hospital capacity, and this would be augmented by absenteeism of healthcare workers (HCW). Strategies to prevent absenteeism of HCW are, therefore, desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, and reported significant reductions in morbidity and mortality. The hypothesis is that BCG vaccination can reduce HCW absenteeism during the epidemic phase of Covid-19.
Objective: Primary objective: To reduce absenteeism among HCW with direct patient contacts during the epidemic phase of Covid-19. Secondary objective: To reduce hospital admission, ICU admission or death in HCW with direct patient contacts during the epidemic phase of Covid-19.
Read more
Study design: A placebo-controlled adaptive multi-centre randomized controlled trial.
Study population: HCW with direct patient contacts among which nurses and physicians working at emergency rooms and wards where Covid-19-infected patients are treated.
Intervention: Participants will be randomized between intracutaneous administration of BCG vaccine or placebo in a 1:1 ratio.
Main study parameters/endpoints: Primary endpoint: number of days of (unplanned) absenteeism for any reason. Secondary endpoints include the number of days of (unplanned) absenteeism because of documented Covid-19 infection, and the cumulative incidence of hospital admission, Intensive Care Admission, and death.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Based on previous experience and randomized controlled trials in adult and elderly individuals, the risks of BCG vaccination are considered low. The objective of this trial is to evaluate the beneficial effects of BCG vaccination through a lower work absenteeism rate of HCW and/or a mitigated clinical course of Covid-19 infection. The primary endpoint and the adaptive design with frequent interim analyses facilitate maximum efficiency of the trial, so that results can inform policy making during the ongoing epidemic.
Read the detailed description
Since the beginning of 2020, SARS-CoV-2 spread rapidly throughout China and the rest of the world, with on 27 February 2020 the first detected case in the Netherlands.
According to the WHO, Health-care workers (HCW) face an elevated risk of exposure to - and infection of Covid-19.
Bacillus Calmette-Guérin (BCG) was developed as a vaccine against tuberculosis, but studies have shown its ability to induce potent protection against other infectious diseases: the so called non-specific effects (NSEs). A favorable in vitro or in vivo effect has been observed in studies for distinct viral pathogens, e.g. respiratory syncytial virus, yellow fever, herpes simplex virus; human papilloma virus.
Based on the capacity of BCG to reduce the incidence of respiratory tract infections in children, to exert antiviral effects in experimental models; and to reduce viremia in an experimental human model of viral infection, the hypothesis is that BCG vaccination induces (partial) protection against susceptibility to and/or severity of Covid-19 infection. This study evaluates the efficacy of BCG to improve the clinical course of Covid-19 infection and to prevent absenteeism in order to safeguard continuous patient care.
This randomized controlled trial has been designed as a pragmatic study with a highly feasible primary endpoint, which is unplanned absenteeism, that can be continuously measured on a bi-weekly basis). This allows for the most rapid identification of a beneficial outcome that would allow other HCWs to also benefit from the intervention if and as soon as it has been demonstrated to be effective.
- Conditions
- COVID-19
- Being tested
- BCG Vaccine, Placebo
- Keywords
- Health care workers
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG VaccineDrug
Also called Danish strain 1331
Intracutaneously 0.1ml BCG vaccine, which accounts for 0.075mg of attenuated Mycobacterium bovis
PlaceboDrug
Also called NaCl 0,9%
Intracutaneously 0.1ml NaCl 0,9%
| Study group | Role | What they receive |
|---|---|---|
| BCG vaccine | Experimental | Intracutaneously 0.1ml BCG vaccine, which accounts for 0.075mg of attenuated Mycobacterium bovis. Receives: Drug: BCG Vaccine |
| Placebo | Placebo comparator | Intracutaneously 0.1ml of 0.9% NaCl solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Care Workers absenteeism
Number of days of unplanned absenteeism for any reason
Measured: Maximum of 365 days
Secondary outcomes (18)
the cumulative incidence of documented COVID-19
Measured: Maximum of 365 days
the cumulative incidence of Hospital Admission due to documented COVID-19
Measured: Maximum of 365 days
the number of days of unplanned absenteeism, because of documented COVID-19
Measured: Maximum of 365 days
the cumulative incidence of self-reported acute respiratory symptoms or fever
Measured: Maximum of 365 days
the cumulative incidence of death due to documented COVID-19
Measured: Maximum of 365 days
the cumulative incidence of Intensive Care Admission due to documented COVID-19
Measured: Maximum of 365 days
the number of days of absenteeism, because of imposed quarantine as a result of exposure to COVID-19
Exploratory
Measured: Maximum of 365 days
the number of days of absenteeism, because of imposed quarantine as a result of having acute respiratory symptoms, fever or documented COVID-19
Exploratory
Measured: Maximum of 365 days
the number of days of unplanned absenteeism because of self-reported acute respiratory symptoms
Exploratory
Measured: Maximum of 365 days
the number of days of self-reported fever (≥38 gr C)
Exploratory
Measured: Maximum of 365 days
the cumulative incidence of self-reported fever (≥38 gr C)
Exploratory
Measured: Maximum of 365 days
the number of days of self-reported acute respiratory symptoms
Exploratory
Measured: Maximum of 365 days
the cumulative incidence of self-reported acute respiratory symptoms
Exploratory
Measured: Maximum of 365 days
the cumulative incidence of death for any reason
Exploratory
Measured: Maximum of 365 days
the cumulative incidence of Intensive Care Admission for any reason
Exploratory
Measured: Maximum of 365 days
the cumulative incidence of Hospital Admission for any reason
Exploratory
Measured: Maximum of 365 days
the cumulative incidence and magnitude of plasma/serum antibodies (IgA,M,G) and SARS-CoV-2-specific antibodies at 12 weeks after vaccination and at the end of the study period
Exploratory
Measured: Maximum of 365 days
the cumulative incidence and magnitude of plasma/serum antibodies (IgA,M,G) and SARS-CoV-2-specific antibodies at 12 weeks after vaccination and at the end of the study period
Exploratory
Measured: 3-6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start25 Mar 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,511 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Principal investigator, MJM Bonten, UMC Utrecht
- Investigators
- Marc Bonten, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328441
- Sponsor's protocol ID
- NL73249.041.20
- Acronym
- BCG-CORONA
- Status last verified
- Jun 2022
- First submitted
- 27 Mar 2020
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results of this study will be disclosed unreservedly at the end of the study.
Publications
Ten Doesschate T, Moorlag SJCFM, van der Vaart TW, Taks E, Debisarun P, Ten Oever J, Bleeker-Rovers CP, Verhagen PB, Lalmohamed A, Ter Heine R, van Crevel R, van de Wijgert J, Janssen AB, Bonten MJ, van Werkhoven CH, Netea MG; BCG-CORONA study team#. Two Randomized Controlled Trials of Bacillus Calmette-Guerin Vaccination to reduce absenteeism among health care workers and hospital admission by elderly persons during the COVID-19 pandemic: A structured summary of the study protocols for two randomised controlled trials. Trials. 2020 Jun 5;21(1):481. doi: 10.1186/s13063-020-04389-w.
PubMed 32503602
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Health Care Workers Absenteeism in COVID-19 Pandemic by Enhanced Trained Immune Responses Through Bacillus Calmette-Guérin Vaccination, a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04328441
- Acronym / sponsor ID
- BCG-CORONA / NL73249.041.20
- Conditions
- COVID-19
- Keywords
- Health care workers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,511 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 31 Mar 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.
Rationale: Covid-19 spreads rapidly throughout the world. A large epidemic in the Netherlands would seriously challenge the available hospital capacity, and this would be augmented by absenteeism of healthcare workers (HCW). Strategies to prevent absenteeism of HCW are, therefore, desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, and reported significant reductions in morbidity and mortality. The hypothesis is that BCG vaccination can reduce HCW absenteeism during the epidemic phase of Covid-19.
Objective: Primary objective: To reduce absenteeism among HCW with direct patient contacts during the epidemic phase of Covid-19. Secondary objective: To reduce hospital admission, ICU admission or death in HCW with direct patient contacts during the epidemic phase of Covid-19.
Study design: A placebo-controlled adaptive multi-centre randomized controlled trial.
Study population: HCW with direct patient contacts among which nurses and physicians working at emergency rooms and wards where Covid-19-infected patients are treated.
Intervention: Participants will be randomized between intracutaneous administration of BCG vaccine or placebo in a 1:1 ratio.
Main study parameters/endpoints: Primary endpoint: number of days of (unplanned) absenteeism for any reason. Secondary endpoints include the number of days of (unplanned) absenteeism because of documented Covid-19 infection, and the cumulative incidence of hospital admission, Intensive Care Admission, and death.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Based on previous experience and randomized controlled trials in adult and elderly individuals, the risks of BCG vaccination are considered low. The objective of this trial is to evaluate the beneficial effects of BCG vaccination through a lower work absenteeism rate of HCW and/or a mitigated clinical course of Covid-19 infection. The primary endpoint and the adaptive design with frequent interim analyses facilitate maximum efficiency of the trial, so that results can inform policy making during the ongoing epidemic.
Detailed description
Since the beginning of 2020, SARS-CoV-2 spread rapidly throughout China and the rest of the world, with on 27 February 2020 the first detected case in the Netherlands.
According to the WHO, Health-care workers (HCW) face an elevated risk of exposure to - and infection of Covid-19.
Bacillus Calmette-Guérin (BCG) was developed as a vaccine against tuberculosis, but studies have shown its ability to induce potent protection against other infectious diseases: the so called non-specific effects (NSEs). A favorable in vitro or in vivo effect has been observed in studies for distinct viral pathogens, e.g. respiratory syncytial virus, yellow fever, herpes simplex virus; human papilloma virus.
Based on the capacity of BCG to reduce the incidence of respiratory tract infections in children, to exert antiviral effects in experimental models; and to reduce viremia in an experimental human model of viral infection, the hypothesis is that BCG vaccination induces (partial) protection against susceptibility to and/or severity of Covid-19 infection. This study evaluates the efficacy of BCG to improve the clinical course of Covid-19 infection and to prevent absenteeism in order to safeguard continuous patient care.
This randomized controlled trial has been designed as a pragmatic study with a highly feasible primary endpoint, which is unplanned absenteeism, that can be continuously measured on a bi-weekly basis). This allows for the most rapid identification of a beneficial outcome that would allow other HCWs to also benefit from the intervention if and as soon as it has been demonstrated to be effective.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCG vaccine | Experimental | Drug: BCG VaccineIntracutaneously 0.1ml BCG vaccine, which accounts for 0.075mg of attenuated Mycobacterium bovis. |
| Placebo | Placebo comparator | Drug: PlaceboIntracutaneously 0.1ml of 0.9% NaCl solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (≥18 years)
- Male or female
- Hospital personnel (expected to) taking care for patients with SARS CoV-2 infection
Key exclusion criteria (12 listed)
- Known allergy to (components of) the BCG vaccine or serious adverse events to prior BCG administration
- Known active or latent Mycobacterium tuberculosis or with another mycobacterial species. A history with- or a suspicion of M. tuberculosis infection.
- Fever (>38 C) within the past 24 hours
- Pregnancy
- Suspicion of active viral or bacterial infection
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 |
|---|---|---|
| BCG VaccineAlso: Danish strain 1331Intracutaneously 0.1ml BCG vaccine, which accounts for 0.075mg of attenuated Mycobacterium bovis | Drug | BCG vaccine |
| PlaceboAlso: NaCl 0,9%Intracutaneously 0.1ml NaCl 0,9% | Drug | Placebo |
Primary outcome
Health Care Workers absenteeism
Time frame: Maximum of 365 days
Number of days of unplanned absenteeism for any reason
18 secondary outcomes
the cumulative incidence of documented COVID-19
Time frame: Maximum of 365 days
the cumulative incidence of Hospital Admission due to documented COVID-19
Time frame: Maximum of 365 days
the number of days of unplanned absenteeism, because of documented COVID-19
Time frame: Maximum of 365 days
the cumulative incidence of self-reported acute respiratory symptoms or fever
Time frame: Maximum of 365 days
the cumulative incidence of death due to documented COVID-19
Time frame: Maximum of 365 days
the cumulative incidence of Intensive Care Admission due to documented COVID-19
Time frame: Maximum of 365 days
the number of days of absenteeism, because of imposed quarantine as a result of exposure to COVID-19
Time frame: Maximum of 365 days
the number of days of absenteeism, because of imposed quarantine as a result of having acute respiratory symptoms, fever or documented COVID-19
Time frame: Maximum of 365 days
the number of days of unplanned absenteeism because of self-reported acute respiratory symptoms
Time frame: Maximum of 365 days
the number of days of self-reported fever (≥38 gr C)
Time frame: Maximum of 365 days
the cumulative incidence of self-reported fever (≥38 gr C)
Time frame: Maximum of 365 days
the number of days of self-reported acute respiratory symptoms
Time frame: Maximum of 365 days
the cumulative incidence of self-reported acute respiratory symptoms
Time frame: Maximum of 365 days
the cumulative incidence of death for any reason
Time frame: Maximum of 365 days
the cumulative incidence of Intensive Care Admission for any reason
Time frame: Maximum of 365 days
the cumulative incidence of Hospital Admission for any reason
Time frame: Maximum of 365 days
the cumulative incidence and magnitude of plasma/serum antibodies (IgA,M,G) and SARS-CoV-2-specific antibodies at 12 weeks after vaccination and at the end of the study period
Time frame: Maximum of 365 days
the cumulative incidence and magnitude of plasma/serum antibodies (IgA,M,G) and SARS-CoV-2-specific antibodies at 12 weeks after vaccination and at the end of the study period
Time frame: 3-6 months after inclusion
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 3 Jun 2022.
- Derived from this study: PubMed 32503602Ten Doesschate T, Moorlag SJCFM, van der Vaart TW, Taks E, Debisarun P, Ten Oever J, Bleeker-Rovers CP, Verhagen PB, Lalmohamed A, Ter Heine R, van Crevel R, van de Wijgert J, Janssen AB, Bonten MJ, van Werkhoven CH, Netea MG; BCG-CORONA study team#. Two Randomized Controlled Trials of Bacillus Calmette-Guerin Vaccination to reduce absenteeism among health care workers and hospital admission by elderly persons during the COVID-19 pandemic: A structured summary of the study protocols for two randomised controlled trials. Trials. 2020 Jun 5;21(1):481. doi: 10.1186/s13063-020-04389-w.
- Individual participant dataSharing planned: Yes. The results of this study will be disclosed unreservedly at the end of the study.
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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.
Marc Bonten, MD, PhD principal investigator
UMC Utrecht
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BCG Vaccine in people with COVID-19, run by UMC Utrecht at 9 sites in Netherlands.
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 3 inclusion and 12 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 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands. 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?
Health Care Workers absenteeism (time frame: Maximum of 365 days). 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 NCT04328441, which also lists 1 linked publication.
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 3 Jun 2022.