COVID-19Phase 3NCT04362124
Performance Evaluation of BCG Vaccination in Healthcare Personnel to Reduce the Severity of COVID-19 Infection.
A Phase 3 study testing vaccine BCG in people with COVID-19, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
Until the first half of April, Colombia has more than 2,800 infected cases and a hundred deaths as a result of COVID-19, with Antioquia being the third department with the highest number of cases. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- vaccine BCG
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteColombia
- Study dates
- Aug 2020to Nov 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women
- Between ≥18 and ≤ 65 years old
- Healthcare workers (doctors, nurses and nursing assistants) from clinics and hospitals in Medellín, who are directly involved in the care of patients with COVID-19
- A negative test for COVID-19 and being asymptomatic at baseline
- Are able and willing to give signed informed consent (Subjects whom the investigator believes are able to understand and are willing to comply with the requirements of the protocol)
Who cannot join
- Have a previous diagnosis (probable or confirmed) of COVID-19
- Immunosuppression (pharmacological or clinical)
- Are taking immunosuppressive medications
- Pregnant or lactating women; or women of childbearing age who do not agree to take contraceptives during the month following vaccination.
- Have received any live or replicative vaccine one month before the time of screening.
- Permanent teleworking activity.
Show all 10Show fewer
- History of active tuberculosis
- Currently are receiving Hydroxychloroquine, Chloroquine, Lopinavir/ritonavir, Tocilizumab, or Azithromycin.
- Known or suspected history of hypersensitivity to vaccines.
- Patients who do not wish to attend or who cannot keep up with the follow-up visits.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Program for Research and Control in Tropical Diseases - PECET
Medellín, Antioquia, 0004
About this study
Official title: Performance Evaluation of BCG Vaccination in Healthcare Personnel to Reduce the Severity of SARS-COV-2 Infection in Medellín, Colombia, 2020
Until the first half of April, Colombia has more than 2,800 infected cases and a hundred deaths as a result of COVID-19, with Antioquia being the third department with the highest number of cases. Official records indicate that, in Colombia, the first case was diagnosed on March 6, 2020, corresponding to a patient from Italy. However, in conversations with several infectologists and intensivists from Medellín, it was agreed that clinical cases similar to the clinical presentation that is now recognized as COVID-19 had arisen since the end of 2019 when it was still unknown to everyone. The previous suggests that the virus was already circulating in the country since before March 6, 2020. But at that moment, there were no tools to make a clinical identification, nor to diagnose it from the laboratory's point of view.
Considering as real the hypothesis that the infection has been circulating in the country since before the first official diagnosis, the question arises: Why does not the country still has the same healthcare and humanitarian chaos that countries such as Italy and Spain are suffering at this time? To answer this question may be that there are differences in vaccination rates with BCG (Bacille Calmette-Guérin or tuberculosis vaccine), which is significantly higher in Latin America compared to those in Europe. This finding could explain to some extent the situation in the country, since previous studies have shown the influence that this vaccine can have on the immune response against various other pathogens, including viruses.
Read more
Among the population at risk of infection, health-care workers due to their permanent contact with patients are the population group with the highest risk of contracting SARS-Cov-2 and developing COVID-19 in any of its clinical manifestations, and currently there are no vaccines or proven preventive interventions available to protect them.
For this reason, this research study aims to demonstrate whether the centennial vaccine against tuberculosis (BCG), a bacterial disease, can activate the human immune system in a broad way, allowing it to better combat the coronavirus that causes COVID-19 and, perhaps, prevents the complications that lead the patient to the intensive care unit and death.
In the future, and if these results are as expected, they may be the basis for undertaking a population vaccination campaign that improves clinical outcomes in the general population.
Read the detailed description
Problem Statement
To date, Colombia has more than 2,800 infected cases and a hundred deaths as a result of COVID-19, with Antioquia being the third department with the highest number of cases (1). Official records indicate that, in Colombia, the first case was diagnosed on March 6, 2020, corresponding to a patient from Italy. However, in conversations with several infectologists and intensivists from Medellín, it was agreed that clinical cases similar to the clinical presentation that is now recognized as COVID-19 had arisen since the end of 2019 when it was still unknown to everyone. The previous suggests that the virus was already circulating in the country since before March 6, 2020. But at that moment, there were no tools to make a clinical identification, nor to diagnose it from the laboratory's point of view. This theory has been gathering momentum in other latitudes, demonstrating how the asymptomatic infected individuals are responsible for spreading the infection .
Considering as real the hypothesis that the infection has been circulating in the country since before the first official diagnosis, the question arises: Why does not the country still has the same healthcare and humanitarian chaos that countries such as Italy and Spain are suffering at this time? To answer this question, an extensive literature search of factors that differentiate Europeans from Latin Americans was carried out. Finding, in addition to genetic factors specific to race, differences in the number of ACEI receptors (binding site of the coronavirus to the alveolus), and differences in vaccination rates with BCG (Bacille Calmette-Guérin or tuberculosis vaccine), which is significantly higher in Latin America compared to those in Europe (3). This last finding could explain to some extent the situation in the country, since previous studies have shown the influence that this vaccine can have on the immune response against various other pathogens, including viruses (4,5).
Among the population at risk of infection, health-care workers due to their permanent contact with patients are the population group with the highest risk of contracting SARS-Cov-2 and developing COVID-19 in any of its clinical manifestations.
Currently, there are no vaccines or proven preventive interventions available to protect health-care workers. However, researchers from Germany, the Netherlands, Australia, and France are working on a clinical trial with an unorthodox approach to combat this new virus. This research study aims to demonstrate whether the centennial vaccine against tuberculosis (BCG), a bacterial disease, can activate the human immune system in a broad way, allowing it to better combat the coronavirus that causes COVID-19 and, perhaps, prevents the complications that lead the patient to the intensive care unit and death. Initially, studies in these four countries will be carried out on doctors and nurses, since they are the ones with a higher risk of becoming infected compared to the general population.
Currently, the available evidence supports the hypothesis that BCG vaccination has beneficial heterologous effects against viral, bacterial, and fungal infections. The basis of these effects has been little explored in humans; however, this knowledge opens the door to future research to explore the effect of "trained immunity" associated with this vaccine, both for diseases in hosts with immunological disorders, and for autoinflammatory diseases, in which there is an inappropriate activation of inflammation (21). All of the findings described have considerable potential to aid in the design of new therapeutic strategies, such as the use of old and new vaccines that combine classical immune memory, and the activation of innate immunity by "trained immunity," for prevention and treatment of infections, and modulation of exaggerated inflammation in autoinflammatory diseases.
A multicenter, double-blind, randomized, phase III clinical trial will be carried out. 1000 healthy healthcare workers (doctors, nurses, and nursing assistants) with a negative test for COVID-19 and asymptomatic for the disease will be randomly assigned to receive one dose of BGC vaccine or placebo (saline solution). Volunteers will be followed for one year.
Hypothesis Healthcare workers who have negative SARS-Cov-2 serology and who receive the BCG vaccine, have a better clinical outcome if they become infected with COVID-19, in terms of not getting sick, requiring hospitalization or dying, than those who do not receive the vaccine.
Objectives
Overall Objective
Evaluate the performance of BCG vaccination in reducing the severity of SARS-COV-2 infection compared to the placebo, in healthcare personnel from Medellín, Colombia.
. Specific Objectives
- Determine if there are differences in the clinical outcome in terms of not getting sick, requiring hospitalization, or dying in both treatment groups.
- Estimate previous exposure of healthcare personnel to SARS-Cov-2 by conducting rapid tests that measure IgG and IgM immunity.
- Assess the safety (frequency, seriousness, and severity of adverse events) of BCG vaccination in an adult population.
- Estimate SARS-Cov-2 infection in healthcare personnel at the end of the study, by performing rapid tests that measure IgG and IgM immunity.
- Conditions
- COVID-19
- Being tested
- vaccine BCG, Placebo
- Keywords
- coronavirus, BCG, COVID-19, SARS-COV-2
- 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.
vaccine BCGBiological
Also called BCG Liofilizada
Performance evaluation of a single dose of BCG vaccine in reducing the severity of SARS-COV-2 infection compared to placebo, in healthcare personnel.
PlaceboOther
A single dose intradermal application of normal saline solution.
| Study group | Role | What they receive |
|---|---|---|
| vaccine BCG | Experimental | A single dose intradermal application of 0.1 ml of between 1 x 105 to 33 x 105 CFU of BCG, in the deltoid of the non-dominant arm.
Follow-up of the participant up to day 360. The frequency and intensity of possible Adverse Events, reactions, and symptoms that appear, and other reactions stipulated in the protocol will be documented in the subject's diary. Receives: Biological: vaccine BCG |
| Placebo | Placebo comparator | A single dose intradermal application of 0.1ml of normal saline solution, in the deltoid of the non-dominant arm.
Follow-up of the participant up to day 360. The frequency and intensity of possible Adverse Events, reactions, and symptoms that appear, and other reactions stipulated in the protocol will be documented in the subject's diary. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
Incidence of COVID-19 cases confirmed or probable in the study population
Measured: From date of randomization to 360 day of the study
Secondary outcomes (4)
Secondary outcome
Incidence of severe or critical infection in COVID-19 cases
Measured: From date to diagnosis to 1 month after
Secondary outcome
Lethality of the infection in both groups
Measured: From date to diagnosis to 1 month after
Secondary outcome
Assess the safety (frequency, seriousness, and severity of adverse events) of BCG vaccination
Measured: From date of randomization to 7 day of the study
Secondary outcome
Prevalence of SARS-Cov-2 infection
Measured: At baseline evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study startAug 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionNov 2021 (estimated)
Why it stopped: Study was stopped because Principal Investigator did not obtain sponsorship to carry it out
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter, double-blind, randomized, phase III clinical trial, divided into two groups (vaccine and placebo) using a 1: 1 allocation ratio. The treatment allocation will be performed according to random code.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan C cataño, MD.MI.ID, Principal investigator, infectious medicine doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362124
- Sponsor's protocol ID
- PEC03_2020
- Status last verified
- Apr 2020
- First submitted
- 21 Apr 2020
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li R, Pei S, Chen B, Song Y, Zhang T, Yang W, Shaman J. Substantial undocumented infection facilitates the rapid dissemination of novel coronavirus (SARS-CoV-2). Science. 2020 May 1;368(6490):489-493. doi: 10.1126/science.abb3221. Epub 2020 Mar 16.
PubMed 32179701Zwerling A, Behr MA, Verma A, Brewer TF, Menzies D, Pai M. The BCG World Atlas: a database of global BCG vaccination policies and practices. PLoS Med. 2011 Mar;8(3):e1001012. doi: 10.1371/journal.pmed.1001012. Epub 2011 Mar 22.
PubMed 21445325Arts RJW, Moorlag SJCFM, Novakovic B, Li Y, Wang SY, Oosting M, Kumar V, Xavier RJ, Wijmenga C, Joosten LAB, Reusken CBEM, Benn CS, Aaby P, Koopmans MP, Stunnenberg HG, van Crevel R, Netea MG. BCG Vaccination Protects against Experimental Viral Infection in Humans through the Induction of Cytokines Associated with Trained Immunity. Cell Host Microbe. 2018 Jan 10;23(1):89-100.e5. doi: 10.1016/j.chom.2017.12.010.
PubMed 29324233Moorlag SJCFM, Arts RJW, van Crevel R, Netea MG. Non-specific effects of BCG vaccine on viral infections. Clin Microbiol Infect. 2019 Dec;25(12):1473-1478. doi: 10.1016/j.cmi.2019.04.020. Epub 2019 May 2.
PubMed 31055165Netea MG, Joosten LA, Latz E, Mills KH, Natoli G, Stunnenberg HG, O'Neill LA, Xavier RJ. Trained immunity: A program of innate immune memory in health and disease. Science. 2016 Apr 22;352(6284):aaf1098. doi: 10.1126/science.aaf1098. Epub 2016 Apr 21.
PubMed 27102489Benn CS, Netea MG, Selin LK, Aaby P. A small jab - a big effect: nonspecific immunomodulation by vaccines. Trends Immunol. 2013 Sep;34(9):431-9. doi: 10.1016/j.it.2013.04.004. Epub 2013 May 14.
PubMed 23680130Jensen KJ, Larsen N, Biering-Sorensen S, Andersen A, Eriksen HB, Monteiro I, Hougaard D, Aaby P, Netea MG, Flanagan KL, Benn CS. Heterologous immunological effects of early BCG vaccination in low-birth-weight infants in Guinea-Bissau: a randomized-controlled trial. J Infect Dis. 2015 Mar 15;211(6):956-67. doi: 10.1093/infdis/jiu508. Epub 2014 Sep 9.
PubMed 25210141Kleinnijenhuis J, van Crevel R, Netea MG. Trained immunity: consequences for the heterologous effects of BCG vaccination. Trans R Soc Trop Med Hyg. 2015 Jan;109(1):29-35. doi: 10.1093/trstmh/tru168.
PubMed 25573107Uthayakumar D, Paris S, Chapat L, Freyburger L, Poulet H, De Luca K. Non-specific Effects of Vaccines Illustrated Through the BCG Example: From Observations to Demonstrations. Front Immunol. 2018 Dec 4;9:2869. doi: 10.3389/fimmu.2018.02869. eCollection 2018.
PubMed 30564249Tribouley J, Tribouley-Duret J, Appriou M. [Effect of Bacillus Callmette Guerin (BCG) on the receptivity of nude mice to Schistosoma mansoni]. C R Seances Soc Biol Fil. 1978;172(5):902-4. French.
PubMed 157204Kleinnijenhuis J, Quintin J, Preijers F, Benn CS, Joosten LA, Jacobs C, van Loenhout J, Xavier RJ, Aaby P, van der Meer JW, van Crevel R, Netea MG. Long-lasting effects of BCG vaccination on both heterologous Th1/Th17 responses and innate trained immunity. J Innate Immun. 2014;6(2):152-8. doi: 10.1159/000355628. Epub 2013 Oct 30.
PubMed 24192057Sher NA, Chaparas SD, Greenberg LE, Bernard S. Effects of BCG, Corynebacterium parvum, and methanol-extration residue in the reduction of mortality from Staphylococcus aureus and Candida albicans infections in immunosuppressed mice. Infect Immun. 1975 Dec;12(6):1325-30. doi: 10.1128/iai.12.6.1325-1330.1975.
PubMed 1107224Sakuma T, Suenaga T, Yoshida I, Azuma M. Mechanisms of enhanced resistance of Mycobacterium bovis BCG-treated mice to ectromelia virus infection. Infect Immun. 1983 Nov;42(2):567-73. doi: 10.1128/iai.42.2.567-573.1983.
PubMed 6315580Kleinnijenhuis 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 22988082Brandau S, Riemensberger J, Jacobsen M, Kemp D, Zhao W, Zhao X, Jocham D, Ratliff TL, Bohle A. NK cells are essential for effective BCG immunotherapy. Int J Cancer. 2001 Jun 1;92(5):697-702. doi: 10.1002/1097-0215(20010601)92:53.0.co;2-z.
PubMed 11340575
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of BCG Vaccination in Healthcare Personnel to Reduce the Severity of SARS-COV-2 Infection in Medellín, Colombia, 2020
- ClinicalTrials.gov ID
- NCT04362124
- Acronym / sponsor ID
- PEC03_2020
- Conditions
- COVID-19
- Keywords
- coronavirus, BCG, COVID-19, SARS-COV-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was stopped because Principal Investigator did not obtain sponsorship to carry it out
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 24 Apr 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.
Until the first half of April, Colombia has more than 2,800 infected cases and a hundred deaths as a result of COVID-19, with Antioquia being the third department with the highest number of cases. Official records indicate that, in Colombia, the first case was diagnosed on March 6, 2020, corresponding to a patient from Italy. However, in conversations with several infectologists and intensivists from Medellín, it was agreed that clinical cases similar to the clinical presentation that is now recognized as COVID-19 had arisen since the end of 2019 when it was still unknown to everyone. The previous suggests that the virus was already circulating in the country since before March 6, 2020. But at that moment, there were no tools to make a clinical identification, nor to diagnose it from the laboratory's point of view.
Considering as real the hypothesis that the infection has been circulating in the country since before the first official diagnosis, the question arises: Why does not the country still has the same healthcare and humanitarian chaos that countries such as Italy and Spain are suffering at this time? To answer this question may be that there are differences in vaccination rates with BCG (Bacille Calmette-Guérin or tuberculosis vaccine), which is significantly higher in Latin America compared to those in Europe. This finding could explain to some extent the situation in the country, since previous studies have shown the influence that this vaccine can have on the immune response against various other pathogens, including viruses.
Among the population at risk of infection, health-care workers due to their permanent contact with patients are the population group with the highest risk of contracting SARS-Cov-2 and developing COVID-19 in any of its clinical manifestations, and currently there are no vaccines or proven preventive interventions available to protect them.
For this reason, this research study aims to demonstrate whether the centennial vaccine against tuberculosis (BCG), a bacterial disease, can activate the human immune system in a broad way, allowing it to better combat the coronavirus that causes COVID-19 and, perhaps, prevents the complications that lead the patient to the intensive care unit and death.
In the future, and if these results are as expected, they may be the basis for undertaking a population vaccination campaign that improves clinical outcomes in the general population.
Detailed description
Problem Statement
To date, Colombia has more than 2,800 infected cases and a hundred deaths as a result of COVID-19, with Antioquia being the third department with the highest number of cases (1). Official records indicate that, in Colombia, the first case was diagnosed on March 6, 2020, corresponding to a patient from Italy. However, in conversations with several infectologists and intensivists from Medellín, it was agreed that clinical cases similar to the clinical presentation that is now recognized as COVID-19 had arisen since the end of 2019 when it was still unknown to everyone. The previous suggests that the virus was already circulating in the country since before March 6, 2020. But at that moment, there were no tools to make a clinical identification, nor to diagnose it from the laboratory's point of view. This theory has been gathering momentum in other latitudes, demonstrating how the asymptomatic infected individuals are responsible for spreading the infection .
Considering as real the hypothesis that the infection has been circulating in the country since before the first official diagnosis, the question arises: Why does not the country still has the same healthcare and humanitarian chaos that countries such as Italy and Spain are suffering at this time? To answer this question, an extensive literature search of factors that differentiate Europeans from Latin Americans was carried out. Finding, in addition to genetic factors specific to race, differences in the number of ACEI receptors (binding site of the coronavirus to the alveolus), and differences in vaccination rates with BCG (Bacille Calmette-Guérin or tuberculosis vaccine), which is significantly higher in Latin America compared to those in Europe (3). This last finding could explain to some extent the situation in the country, since previous studies have shown the influence that this vaccine can have on the immune response against various other pathogens, including viruses (4,5).
Among the population at risk of infection, health-care workers due to their permanent contact with patients are the population group with the highest risk of contracting SARS-Cov-2 and developing COVID-19 in any of its clinical manifestations.
Currently, there are no vaccines or proven preventive interventions available to protect health-care workers. However, researchers from Germany, the Netherlands, Australia, and France are working on a clinical trial with an unorthodox approach to combat this new virus. This research study aims to demonstrate whether the centennial vaccine against tuberculosis (BCG), a bacterial disease, can activate the human immune system in a broad way, allowing it to better combat the coronavirus that causes COVID-19 and, perhaps, prevents the complications that lead the patient to the intensive care unit and death. Initially, studies in these four countries will be carried out on doctors and nurses, since they are the ones with a higher risk of becoming infected compared to the general population.
Currently, the available evidence supports the hypothesis that BCG vaccination has beneficial heterologous effects against viral, bacterial, and fungal infections. The basis of these effects has been little explored in humans; however, this knowledge opens the door to future research to explore the effect of "trained immunity" associated with this vaccine, both for diseases in hosts with immunological disorders, and for autoinflammatory diseases, in which there is an inappropriate activation of inflammation (21). All of the findings described have considerable potential to aid in the design of new therapeutic strategies, such as the use of old and new vaccines that combine classical immune memory, and the activation of innate immunity by "trained immunity," for prevention and treatment of infections, and modulation of exaggerated inflammation in autoinflammatory diseases.
A multicenter, double-blind, randomized, phase III clinical trial will be carried out. 1000 healthy healthcare workers (doctors, nurses, and nursing assistants) with a negative test for COVID-19 and asymptomatic for the disease will be randomly assigned to receive one dose of BGC vaccine or placebo (saline solution). Volunteers will be followed for one year.
Hypothesis Healthcare workers who have negative SARS-Cov-2 serology and who receive the BCG vaccine, have a better clinical outcome if they become infected with COVID-19, in terms of not getting sick, requiring hospitalization or dying, than those who do not receive the vaccine.
Objectives
Overall Objective
Evaluate the performance of BCG vaccination in reducing the severity of SARS-COV-2 infection compared to the placebo, in healthcare personnel from Medellín, Colombia.
. Specific Objectives
- Determine if there are differences in the clinical outcome in terms of not getting sick, requiring hospitalization, or dying in both treatment groups.
- Estimate previous exposure of healthcare personnel to SARS-Cov-2 by conducting rapid tests that measure IgG and IgM immunity.
- Assess the safety (frequency, seriousness, and severity of adverse events) of BCG vaccination in an adult population.
- Estimate SARS-Cov-2 infection in healthcare personnel at the end of the study, by performing rapid tests that measure IgG and IgM immunity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A multicenter, double-blind, randomized, phase III clinical trial, divided into two groups (vaccine and placebo) using a 1: 1 allocation ratio. The treatment allocation will be performed according to random code.
| Arm | Type | Receives |
|---|---|---|
| vaccine BCG | Experimental | Biological: vaccine BCGA single dose intradermal application of 0.1 ml of between 1 x 105 to 33 x 105 CFU of BCG, in the deltoid of the non-dominant arm. Follow-up of the participant up to day 360. The frequency and intensity of possible Adverse Events, reactions, and symptoms that appear, and other reactions stipulated in the protocol will be documented in the subject's diary. |
| Placebo | Placebo comparator | Other: PlaceboA single dose intradermal application of 0.1ml of normal saline solution, in the deltoid of the non-dominant arm. Follow-up of the participant up to day 360. The frequency and intensity of possible Adverse Events, reactions, and symptoms that appear, and other reactions stipulated in the protocol will be documented in the subject's diary. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women
- Between ≥18 and ≤ 65 years old
- Healthcare workers (doctors, nurses and nursing assistants) from clinics and hospitals in Medellín, who are directly involved in the care of patients with COVID-19
- A negative test for COVID-19 and being asymptomatic at baseline
- Are able and willing to give signed informed consent (Subjects whom the investigator believes are able to understand and are willing to comply with the requirements of the protocol)
Key exclusion criteria (10 listed)
- Have a previous diagnosis (probable or confirmed) of COVID-19
- Immunosuppression (pharmacological or clinical)
- Are taking immunosuppressive medications
- Pregnant or lactating women; or women of childbearing age who do not agree to take contraceptives during the month following vaccination.
- Have received any live or replicative vaccine one month before the time of screening.
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 |
|---|---|---|
| vaccine BCGAlso: BCG LiofilizadaPerformance evaluation of a single dose of BCG vaccine in reducing the severity of SARS-COV-2 infection compared to placebo, in healthcare personnel. | Biological | vaccine BCG |
| PlaceboA single dose intradermal application of normal saline solution. | Other | Placebo |
Primary outcome
Primary outcome
Time frame: From date of randomization to 360 day of the study
Incidence of COVID-19 cases confirmed or probable in the study population
4 secondary outcomes
Secondary outcome
Time frame: From date to diagnosis to 1 month after
Secondary outcome
Time frame: From date to diagnosis to 1 month after
Secondary outcome
Time frame: From date of randomization to 7 day of the study
Secondary outcome
Time frame: At baseline evaluation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Background: PubMed 32179701Li R, Pei S, Chen B, Song Y, Zhang T, Yang W, Shaman J. Substantial undocumented infection facilitates the rapid dissemination of novel coronavirus (SARS-CoV-2). Science. 2020 May 1;368(6490):489-493. doi: 10.1126/science.abb3221. Epub 2020 Mar 16.
- Background: PubMed 21445325Zwerling A, Behr MA, Verma A, Brewer TF, Menzies D, Pai M. The BCG World Atlas: a database of global BCG vaccination policies and practices. PLoS Med. 2011 Mar;8(3):e1001012. doi: 10.1371/journal.pmed.1001012. Epub 2011 Mar 22.
- Background: PubMed 29324233Arts RJW, Moorlag SJCFM, Novakovic B, Li Y, Wang SY, Oosting M, Kumar V, Xavier RJ, Wijmenga C, Joosten LAB, Reusken CBEM, Benn CS, Aaby P, Koopmans MP, Stunnenberg HG, van Crevel R, Netea MG. BCG Vaccination Protects against Experimental Viral Infection in Humans through the Induction of Cytokines Associated with Trained Immunity. Cell Host Microbe. 2018 Jan 10;23(1):89-100.e5. doi: 10.1016/j.chom.2017.12.010.
- Background: PubMed 31055165Moorlag SJCFM, Arts RJW, van Crevel R, Netea MG. Non-specific effects of BCG vaccine on viral infections. Clin Microbiol Infect. 2019 Dec;25(12):1473-1478. doi: 10.1016/j.cmi.2019.04.020. Epub 2019 May 2.
- Background: PubMed 27102489Netea MG, Joosten LA, Latz E, Mills KH, Natoli G, Stunnenberg HG, O'Neill LA, Xavier RJ. Trained immunity: A program of innate immune memory in health and disease. Science. 2016 Apr 22;352(6284):aaf1098. doi: 10.1126/science.aaf1098. Epub 2016 Apr 21.
- Background: PubMed 23680130Benn CS, Netea MG, Selin LK, Aaby P. A small jab - a big effect: nonspecific immunomodulation by vaccines. Trends Immunol. 2013 Sep;34(9):431-9. doi: 10.1016/j.it.2013.04.004. Epub 2013 May 14.
- Background: PubMed 25210141Jensen KJ, Larsen N, Biering-Sorensen S, Andersen A, Eriksen HB, Monteiro I, Hougaard D, Aaby P, Netea MG, Flanagan KL, Benn CS. Heterologous immunological effects of early BCG vaccination in low-birth-weight infants in Guinea-Bissau: a randomized-controlled trial. J Infect Dis. 2015 Mar 15;211(6):956-67. doi: 10.1093/infdis/jiu508. Epub 2014 Sep 9.
- Background: PubMed 25573107Kleinnijenhuis J, van Crevel R, Netea MG. Trained immunity: consequences for the heterologous effects of BCG vaccination. Trans R Soc Trop Med Hyg. 2015 Jan;109(1):29-35. doi: 10.1093/trstmh/tru168.
- Background: PubMed 30564249Uthayakumar D, Paris S, Chapat L, Freyburger L, Poulet H, De Luca K. Non-specific Effects of Vaccines Illustrated Through the BCG Example: From Observations to Demonstrations. Front Immunol. 2018 Dec 4;9:2869. doi: 10.3389/fimmu.2018.02869. eCollection 2018.
- Background: PubMed 157204Tribouley J, Tribouley-Duret J, Appriou M. [Effect of Bacillus Callmette Guerin (BCG) on the receptivity of nude mice to Schistosoma mansoni]. C R Seances Soc Biol Fil. 1978;172(5):902-4. French.
- Background: PubMed 24192057Kleinnijenhuis J, Quintin J, Preijers F, Benn CS, Joosten LA, Jacobs C, van Loenhout J, Xavier RJ, Aaby P, van der Meer JW, van Crevel R, Netea MG. Long-lasting effects of BCG vaccination on both heterologous Th1/Th17 responses and innate trained immunity. J Innate Immun. 2014;6(2):152-8. doi: 10.1159/000355628. Epub 2013 Oct 30.
- Background: PubMed 1107224Sher NA, Chaparas SD, Greenberg LE, Bernard S. Effects of BCG, Corynebacterium parvum, and methanol-extration residue in the reduction of mortality from Staphylococcus aureus and Candida albicans infections in immunosuppressed mice. Infect Immun. 1975 Dec;12(6):1325-30. doi: 10.1128/iai.12.6.1325-1330.1975.
- official report of the coronavirus in colombiaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Juan C cataño, MD.MI.ID principal investigator
infectious medicine doctor
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 vaccine BCG in people with COVID-19, run by Universidad de Antioquia at 1 site in Colombia.
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 5 inclusion and 10 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: withdrawn, as of the sponsor's last update on 2 Apr 2026. 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 Colombia. 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 was withdrawn before enrolling participants, so there are no results.
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?
Primary outcome (time frame: From date of randomization to 360 day of the study). 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 NCT04362124, which also lists 18 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 2 Apr 2026.