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NoLast UpdateResionCountryStudy TitleTrial Done byStrainTrial TypeStatusStudy Start DatePrimary Completion Date Study Completion DatePhaseparticipants segmentTarget Sample SizeRegistry numberLink to RegistryLink to Source of information1Link to Source of information2Link to Source of information3Result of the trialConclusionCommentsContact Details
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12022-11-23AmericasBrazilCOVID-19: BCG As Therapeutic Vaccine, Transmission Limitation, and Immunoglobulin Enhancement (BATTLE)University of CampinasActive, not recruitingOctober 1, 2020June 4, 2022August 20234laboratory or clinical-epidemiological confirmation of COVID-19400NCT04369794https://clinicaltrials.gov/ct2/show/NCT04369794https://doi.org/10.1111/joim.13523https://doi.org/10.1111/joim.13523karenferrari@gmail.com
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22023-02-28AmericasBrazilUse of BCG Vaccine as a Preventive Measure for COVID-19 in Health Care Workers (ProBCG)Universidade Federal do Rio de Janeiro
Ministry of Science and Technology, Brazil		Active, not recruiting

Has results: BCG could protect		October 1, 2020October 1, 2021October 1, 20222Healthcare workers752NCT04659941https://clinicaltrials.gov/ct2/show/study/NCT04659941https://www.sciencedirect.com/science/article/pii/S1201971223000656fcqmello@gmail.com
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2020-10-24AmericasBrazilBCG vaccine as preventive measure against COVID-19 in health care workersUniversidade Federal do Rio de JaneiroNot yet recruiting2020-07-152-3Healthcare workers1000RBR-5ysj54http://www.ensaiosclinicos.gov.br/rg/RBR-5ysj54/fcqmello@gmail.com
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32022-03-23AmericasBrazilBCG revaccination of health care professionals working in the COVID-19 pandemic, a preventive strategy to improve innate immune responseUniversidade Federal de GoiasRecruiting

Has results: BCG doesn't protect		2020-08-05180 days2Healthcare workers400RBR-4kjqtghttp://www.ensaiosclinicos.gov.br/rg/RBR-4kjqtg/https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04822-0https://www.frontiersin.org/articles/10.3389/fimmu.2022.841868/fullana_kipnis@ufg.br
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42022-08-24AmericasBrazilThe Role of BCG Vaccine in the Clinical Evolution of COVID-19 and in the Efficacy of Anti-SARS-CoV-2 Vaccines (SARS-CoV-2)Oswaldo Cruz Foundation
University of Sao Paulo
Federal University of Juiz de Fora		RecruitingMay 27, 2021December 31, 2022December 31, 20223Never been infected by SARS-Cov-2 - clinical history and absence of anti-SARS-CoV-2 IgM/IgG antibodies by the rapid test (immediate) and by serology test (later confirmation)
Not having been vaccinated against COVID-19
Be at least 18 years old		556NCT05507671https://clinicaltrials.gov/ct2/show/NCT05507671
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52022-04-18AmericasCanadaEfficacy and Safety of VPM1002 in Reducing SARS-CoV-2 (COVID-19) Infection Rate and Severity (COBRA)University Health Network, Toronto
Serum Institute of India Pvt. Ltd.
Max Planck Institute for Infection Biology
Verity Pharmaceuticals		VPM1002 is a recombinant BCG (rBCG)
Mycobacterium bovis rBCGΔureC::hly		CompletedJune 24, 2020September 9, 2021September 9, 20213Employee/member of: municipal or provincial police service, emergency medical services, fire services, public transport service, health service, food manufacturing facility122NCT04439045https://clinicaltrials.gov/ct2/show/study/NCT04439045miran.kenk@uhn.ca, akipnis@ufg.br
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62020-11-28AmericasColombia
Performance Evaluation of BCG Vaccination in Healthcare Personnel to Reduce the Severity of COVID-19 Infection.		Universidad de AntioquiaWithdrawn (Study was stopped because Principal Investigator did not obtain sponsorship to carry it out)August 2020June 2021November 20213Healthcare workers1000NCT04362124https://clinicaltrials.gov/ct2/show/NCT04362124kataju@hotmail.com, liliana.lopez@pecet-colombia.org
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72020-11-14AmericasMexicoPrevention, Efficacy and Safety of BCG Vaccine in COVID-19 Among Healthcare WorkersHospital UniversitarioTokyo 172 strainActive, not recruitingJuly 21, 2020January 1, 2021January 1, 20213Healthcare workers908NCT04461379https://clinicaltrials.gov/ct2/show/NCT04461379rene.rodriguezgtz@uanl.edu.mx.
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82022-10-20AmericasUSABCG Vaccine for Health Care Workers as Defense Against COVID 19 (BADAS)Texas A&M UniversityBCG Tice strain (procured from Merck)Active, not recruitingApril 20, 2020May 2023May 20234Healthcare workers1800NCT04348370https://clinicaltrials.gov/ct2/show/NCT04348370https://health.tamu.edu/bcgtrial/https://today.tamu.edu/2020/04/29/texas-am-researchers-to-lead-testing-of-tuberculosis-vaccine-to-fight-covid-19/jdcirillo@tamu.edu, Andrew.Dinardo@Bcm.edu
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92021-06-29AmericasUSABCG Against Covid-19 for Prevention and Amelioration of Severity Trial (BAC to the PAST)
Harvard Medical School
Texas Medical Research Associates, L.L.C.		BCG VaccineWithdrawn (At this time it has been decided by the study team the the study will no longer take place in the United States.)September 2021May 2022July 20223Residents of a participating LTCF
70 years or older		0NCT04534803https://clinicaltrials.gov/ct2/show/NCT04534803ximena_tovar@hms.harvard.edu, meredith_brooks@hms.harvard.edu
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102021-03-29AmericasUSABCG Vaccination to Prevent COVID-19 (NUEVA)Henry M. Jackson Foundation for the Advancement of Military Medicine
Harvard Medical School
Uniformed Services University of the Health Sciences
United States Department of Defense		Tice® BCG (for intravesical use) BCG LIVE strain of the BCG (Merck) vaccineWithdrawn (Due to funding - project never enrolled)December 7, 2020March 23, 2021March 23, 20213Healthcare workers0NCT04632537https://clinicaltrials.gov/ct2/show/NCT04632537mspevak@hjf.org
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112021-07-29AmericasUSARepeat BCG Vaccinations for the Treatment of Established Type 1 DiabetesMassachusetts General Hospital
Denise Louise Faustman, MD, Massachusetts General Hospital		Active, not recruitingJanuary 202015 months beginning January 20202Type 1 diabetes treated continuously with insulin from time of diagnosis150NCT02081326https://clinicaltrials.gov/ct2/show/NCT02081326https://www.nature.com/articles/s41598-021-94529-2
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122022-11-23AmericasUSAEarly Phase Clinical Trial About Therapeutic Biological Product Mix for Treating COVID-19 (Spike-BCG)Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair, Medicine Invention Design, IncBiological: Ad26 COVID-19 Spike plus TICE® BCG Mix for Intradermal InjectionActive, not recruitingDecember 28, 2021February 28, 2023February 28, 2023120 Lighter Than Mild COVID-19 Patients20NCT02403505https://clinicaltrials.gov/ct2/show/NCT02403505
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132022-08-17AmericasUSARepeat BCG Vaccinations for the Treatment of Established Type 1 DiabetesMassachusetts General Hospital
Denise Louise Faustman, MD, Massachusetts General Hospital		Tokyo-172Active, not recruiting

Has results: BCG could protect		June 2015July 2025July 20272Type 1 diabetes treated continuously with insulin
Age 18-65		150NCT02081326https://clinicaltrials.gov/ct2/show/NCT02081326https://www.cell.com/cell-reports-medicine/fulltext/S2666-3791(22)00271-3
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142023-10-08EuropeDenmarkUsing BCG Vaccine to Protect Health Care Workers in the COVID-19 PandemicBandim Health Project
University of Southern Denmark		BCG-Denmark
Danish strain 1331		Completed

Has results: BCG doesn't protect		May 18, 2020July 31, 2021October 1, 20213Healthcare workers1293NCT04373291https://clinicaltrials.gov/ct2/show/NCT04373291https://doi.org/10.1186/s13063-020-04714-3https://doi.org/10.1186/s12879-021-06949-0https://academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiad422/7286586cbenn@health.sdu.dk, arosendahl@health.sdu.dk
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2021-10-11EuropeDenmarkBCG vaccine for healthcare workers against COVID-19University of Southern DenmarkBCG Vaccine 'AJ Vaccines'
Danish strain 1331		Completed2020-04-30End of study as well as weekly interim analysis.2021-07-313Healthcare workers15002020-001888-90https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001888-90/DKopen.adm@rsyd.dk
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152022-03-16EuropeDenmarkUsing BCG to Protect Senior Citizens During the COVID-19 PandemicBandim Health Project
Odense Patient Data Explorative Network
Odense University Hospital
Municipality of Odense		BCG-Denmark, AJ Vaccines,Danish strain 1331Active, not recruitingSeptember 15, 2020December 31, 2022September 30, 2023365 Years to 110 Years (Older Adult)1700NCT04542330https://clinicaltrials.gov/ct2/show/NCT04542330arosendahl@health.sdu.dk, cbenn@health.sdu.dk
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162022-10-20EuropeFranceEfficacy of BCG Vaccination in the Prevention of COVID19 Via the Strengthening of Innate Immunity in Health Care Workers (COVID-BCG)Assistance Publique - Hôpitaux de ParisBCG vaccine (AJ Vaccine)UnknownMay 20, 2020February 11, 2021February 11, 20213Healthcare workers1120NCT04384549https://clinicaltrials.gov/ct2/show/study/NCT04384549https://www.20minutes.fr/lille/2915491-20201127-coronavirus-si-bcg-montre-efficacite-arme-precieuse-avenir-estime-chercheur-lilloisodile.launay@aphp.fr, anne.radenne@aphp.fr
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2020-06-06EuropeFranceRandomized controlled trial evaluating the efficacy of vaccination with Bacillus Calmette and Guérin (BCG) in the Prevention of COVID-19 via the strengthening of innate immunity in Health Care Workers.”
COVID-BCG		Assistance Publique Hopitaux de ParisVACCIN BCG AJVaccines,FREEZE-DRIED

Danish strain 1331 ?
https://www.medicines.org.uk/emc/product/9890/smpc		Ongoing2020-04-286month6month3Healthcare workers11202020-001678-31https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001678-31/FRmoufida.dabbech@aphp.fr
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172020-10-01EuropeGermanyStudy to Assess VPM1002 in Reducing Healthcare Professionals' Absenteeism in COVID-19 PandemicVakzine Projekt Management GmbH
FGK Clinical Research GmbH		VPM1002Active, not recruitingMay 25, 2020May 1, 2021May 1, 20213Healthcare workers59NCT04387409https://clinicaltrials.gov/ct2/show/study/NCT04387409https://www.tierversuche-verstehen.de/Tuberkulose-Impfung_gegen_Coronahttps://www.linkedin.com/in/leander-grode-06999b12/?originalSubdomain=de
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182021-10-28EuropeGermanyStudy to Assess VPM1002 in Reducing Hospital Admissions and/or Severe Respiratory Infectious Diseases in Elderly in COVID-19 PandemicVakzine Projekt Management GmbH
FGK Clinical Research GmbH		VPM1002CompletedJune 18, 2020October 12, 2021October 12, 20213Male or female adult (≥ 60 years)2038NCT04435379https://clinicaltrials.gov/ct2/show/study/NCT04435379grode@vakzine-manager.de
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2021-10-28EuropeGermanyA study to investigate whether vaccination with VPM1002 can reduce elderly people's days with severe respiratory infectious diseases at hospital and/or at homeVakzine Projekt Management GmbHRecombinant Mycobacterium bovis rBCGΔureC::hly; VPM1002Completed2020-05-29
From day 0 to day 240		2021-10-123Male or female adult (≥ 60 years)20382020-001675-33https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001675-33/DEinfo@vakzine-manager.de
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192022-07-06EuropeGreeceBacillus Calmette-guérin Vaccination to Prevent COVID-19 (ACTIVATEII)Hellenic Institute for the Study of Sepsis
Radboud University		BCG vaccine Moscow strain 361-1;
Serum Institute of India Pvt. Ltd		Completed

Has results: BCG could protect		May 26, 2020April 28, 2021May 7, 202143.Age >= 50 years
4.History of at least one of the following: a) coronary heart disease; b) chronic obstructive pulmonary disease; c) Charlson’s comorbidity index (CCI) more than 3
5.Negative serum testing for immunoglobulin G and M against SARS-CoV-2
6.Skin tuberculin test diameter less than 10mm"		301NCT04414267https://clinicaltrials.gov/ct2/show/study/NCT04414267https://volos.ert.gr/blog/2020/07/04/i-karditsa-se-ereynitiko-programma-emvoliasmoy-gia-fymatiosi-kai-apotelesmatikotita-stin-covid-19/https://www.medrxiv.org/content/10.1101/2021.05.20.21257520v1https://www.frontiersin.org/articles/10.3389/fimmu.2022.873067/fullBCG revaccination resulted in 68% risk reduction for total COVID19 clinical and microbiological diagnoses (OR 0.32, 95% CI 0.13-0.79). Five patients in the placebo group and one in the BCG-vaccinated group had severe COVID19 that necessitated hospitalization. 3 months after BCG vaccination 1.3% of placebo and 4.7% of BCG-vaccinated volunteers had anti-SARS-CoV-2 antibodies. These data argue that BCG revaccination is safe and protects the elderly against COVID19. BCG revaccination may represent a viable preventive measure against COVID19.egiamarel@med.uoa.gr, antigonebut@yahoo.com
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2020-06-06EuropeGreece
BCG VACCINATION TO PREVENT COVID-19		Hellenic Institute for the Study of SepsisBCG Vaccine (Freeze Dried)
Serum Institute of India Pvt. Ltd		Ongoing2020-05-2690 +/- 5 days
Screening		43.Age >= 50 years
4.History of at least one of the following: a) coronary heart disease; b) chronic obstructive pulmonary disease; c) Charlson’s comorbidity index (CCI) more than 3
5.Negative serum testing for immunoglobulin G and M against SARS-CoV-2
6.Skin tuberculin test diameter less than 10mm		9002020-002448-21https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002448-21/GRhttps://www.neakriti.gr/article/ellada-nea/1578952/1-iouniou-xekina-o-emvoliasmos-gai-ton-koronoio-ufistameno-emvolio-sti-mahi-gia-tin-prostasia-tou-plithusmou/https://www.corona24.news/c/2020/05/27/vaccination-for-coronavirus-begins-on-june-1-existing-vaccine-in-the-battle-to-protect-the-population-greece.htmlheadad@sepsis.gr
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202020-06-06EuropeHungaryBCG vaccination against COVID-19 infection in HungaryNational Korányi Institute of PulmonologyDanish strain 1331, SSI, DenmarkOngoing2020-05-06End of study
Primary End Point (repeat as necessary) Number of days of unplanned absenteeism because of documented COVID-19 ifection		End of study
Secondary End Point (repeat as necessary) Secondary endpoints will be: the duration of hospital admission; the cumulative incidence of documented COVID-19 infection...		3Healthcare workers10002020-001783-28https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001783-28/HUigazgatosag@koranyi.hu
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212022-12-20EuropeNetherlandsReducing Health Care Workers Absenteeism in Covid-19 Pandemic Through BCG Vaccine (BCG-CORONA)UMC Utrecht
Radboud University		Danish strain 1331Completed

Has results: BCG doesn't protect		March 25, 2020March 31, 2021May 30, 20213Healthcare workers1500NCT04328441https://clinicaltrials.gov/ct2/show/NCT04328441https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04389-w#Sec1https://www.medrxiv.org/content/10.1101/2022.12.12.22283282v1.full-texthttps://www.clinicalmicrobiologyandinfection.com/article/S1198-743X(22)00214-2/fulltextm.j.m.bonten@umcutrecht.nl
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222023-10-23EuropeNetherlandsReducing COVID-19 Related Hospital Admission in Elderly by BCG VaccinationRadboud UniversityBCG vaccine (Danish strain 1331, SSI, Denmark)Active, not recruiting

Has results:		April 16, 2020May 2021May 20214Adult (≥ 60 years) 2014NCT04417335https://clinicaltrials.gov/ct2/show/study/NCT04417335https://www.sciencedirect.com/science/article/pii/S2589004223021399https://doi.org/10.1093/cid/ciac182BCG-vaccination had no effect on the incidence of respiratory tract infections, including SARS-CoV-2 infection, in elderly volunteers. However, BCG vaccination improved cytokine responses stimulated by influenza and SARS-CoV-2, and induced stronger antibody titers after Covid-19 infection.mihai.netea@radboudumc.nl
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2021-12-28EuropeNetherlands
Reducing hospital admission of elderly in Coronavirus pandemic by boosting the immune system through vaccination with bacillus Calmette-Guérin (BCG).		RadboudumcDanish strain 1331Completed2020-04-09Between day 0 up to 12 months after inclusionBetween day 0 up to 12 months after inclusion4Adult (≥ 60 years) 20002020-001591-15https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001591-15/NLjaap.tenoever@radboudumc.nl
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232023-02-03EuropeNetherlandsPrevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults (BCG-PRIME)UMC Utrecht
MJM Bonten		BCG-Vaccine SSI [Statens Serum Institut]) - Danish strain 1331Randomized placebo-controlled trial for vaccinationCompleted

Has results: BCG doesn't protect		September 7, 2020July 8, 2021July 8, 20214Age ≥60 years
Having a chronic disease or having undergone major surgery		6112NCT04537663https://clinicaltrials.gov/ct2/show/NCT04537663https://www.umcutrecht.nl/nl/over-ons/nieuws/algemeen/tuberculosis-vaccine-does-not-protect-vulnerable-elderly-people-against-covid-19https://www.clinicaltrials.gov/ProvidedDocs/63/NCT04537663/SAP_000.pdf(2022/10/22)
In the BCG-PRIME study, demonstrated COVID-19 infection in combination with disease symptoms occurred just as often in vulnerable elderly people who received a placebo as in those who received BCG vaccination. The study will be continued to determine whether BCG vaccination affects the severity of COVID-19 infection, or reduces susceptibility to other respiratory infections.		(2021/01/24 Jun)
One reason could be the strain (Danish strain is weak). The other is first-time vaccination or re-vaccination to elderly. So far, what I have seen positive results for from the BCG trials for elderly not limited to Covid19 are the ones that re-vaccinate the elderly.The Netherlands trial may not include that information but we can guess that most of the participants were not BCG vaccinated before since it is done in the Netherlands where BCG vaccination is never mandatory.		C.deHaas-3@umcutrecht.nl
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242021-12-28EuropeNetherlandsReducing health care workers absenteeism in Coronavirus 2019 pandemic nu enhancement of the immune system through vaccination with Bacillus Calmette-GuérinUniversity Medical CenterDanish strain 1331Completed2020-03-17Between day 0 up to day 180 after inclusionThe end of the study is defined as the last patient’s last registration in the mobile application (end of follow-up period). 4Healthcare workers10002020-000919-69https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-000919-69/NLM.J.M.Bonten@umcutrecht.nl
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252021-04-15EuropeNetherlandsImpact of BCG vaccination, originally made to prevent tuberculosis, on the immune response to the COVID-19 vaccine in health care workersRadboudumcEffect of Bacillus Calmette-Guérin vaccination on the immunogenicity of the mRNA BNT162b2 COVID-19 vaccineOngoing2021-03-25The primary endpoint will be analyzed when all blood samples of timepoint Day 21 have been collected.The study ends after the last blood collection. This is time point 4, one year after the first injection of the COVID-19 vaccine.4Healthcare workers
Adults (18-64 years)		402021-000182-33https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000182-33/NLkonstantin.fohse@radboudumc.nl
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262022-11-23EuropeNetherlandsLong Term Effects of BCG Vaccination on Infectious and Immune Mediated Diseases (BCG-LT)Radboud University Medical Center
UMC Utrecht		Danish strain 1331Enrolling by invitationMay 20, 2022July 20, 2022June 20, 202760 Years and older
Completed participation in the BCG-CORONA-ELDERLY or BCG-PRIME study		500NCT05387655https://clinicaltrials.gov/ct2/show/NCT05387655
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272022-02-20EuropePolandClinical Trial Evaluating the Effect of BCG Vaccination on the Incidence and Severity of SARS-CoV-2 Infections Among Healthcare Professionals During the COVID-19 Pandemic in PolandHanna Czajka, University of Rzeszow
Medical Research Agency - Agencja Badań Medycznych		BCG-10 anti-tuberculosis vaccine
Brazilian Moreau sub-strain		Recruiting

Has results: BCG doesn't protect		July 7, 2020December 2020April 20213Healthcare workers1000NCT04648800https://clinicaltrials.gov/ct2/show/study/NCT04648800https://doi.org/10.3390/vaccines10020314The statistical analysis did not reveal any significant correlation between the frequency of incidents suspected of COVID-19 and BCG-10 vaccination, the result of the tuberculin test and the number of scars. The only statistically significant feature was the type of medical profession—nurses became infected more often than doctors or other medical workers (p = 0.02). The results differ from similar trials in other countries. Perhaps this is due to the lack of an unvaccinated control group. The impact of BCG vaccination on the course of COVID-19 requires further research.prorektor.cm@ur.edu.pl, hanna.czajka@onet.pl
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2020-06-11EuropePolandStudy evaluating the impact of BCG vaccination on the incidence and course of SARS-CoV-2 infection among health care workers in Poland during the COVID-19 pandemicUniversity of RzeszówAnti-Tuberculosis Vaccine BCG 10
„BIOMED-LUBLIN” Wytwórnia Surowic i Szczepionek Spółka Akcyjna

Moreau strain		Ongoing2020-06-26
Over the entire 18-month period following the inclusion in the study		From month 3. until the end of the study.3Healthcare workers10002020-002111-22https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002111-22/PLhttps://www.mp.pl/szczepienia/aktualnosci/239023,polska-szczepionka-bcg-w-walce-z-covid-19https://www.rynekzdrowia.pl/Badania-i-rozwoj/Czy-za-lagodniejszy-przebieg-epidemii-koronawirusa-w-Polsce-odpowiada-szczepionka-BCG,208045,11.htmlhanna.czajka@onet.pl
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282020-07-28AsiaIndiaStudy to Evaluate the Efficacy of Recombinant BCG VPM1002 in Reducing Infection Incidence and Disease Severity of SARS-COV-2/COVID-19 Among High-Risk Subjects Serum Institute of India Pvt. Ltd. VPM1002Closed to Recruitment of Participants up to 6 months (180 days) following vaccine administration up to 6 months (180 days) following vaccine administration 3Male or Female subjects ≥ 18 years of age at high-risk of SARS-CoV-2/COVID-19 infection5946CTRI/2020/04/024749http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=42972&EncHid=&userName=bcghttps://pib.gov.in/PressReleseDetailm.aspx?PRID=1641519https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/serum-institute-to-test-if-tb-vaccine-vpm1002-is-effective-against-covid-19/articleshow/74800246.cmshttps://theprint.in/india/bcg-vaccine-trials-to-begin-in-2-weeks-on-high-risk-covid-19-groups-in-maharashtra/405189/drhjs@seruminstitute.com
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292020-06-06AsiaIndiaEffect of BCG-Denmark (Green Signal) on prevention of COVID 19 infection in health care workers – a double blind randomized controlled trial Jawaharlal Institute of Post Graduate Medical Education and Research (JIPMER), Puducherry BCG-Denmark (Green Signal)Not yet recruitingSix months after randomisationSix months after randomisationN/AHealthcare workers1826CTRI/2020/04/024833http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=43105&EncHid=&userName=bcgnarayanan.p@jipmer.edu.in
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302021-01-24AsiaIndiaPhase 2 Clinical Trial for the Evaluation of BCG as potential therapy for CoVID-I9 Haffkine Institute for Training Research TestingTubervac (Serum Institute of India) is derived from the Russian strain, also known as Moscow strain.Has results: BCG could protect3month2male or female with confirmed COVID-19
Age 20 - 50 years		60CTRI/2020/05/025013http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=42858&EncHid=&userName=BCGhttps://www.medrxiv.org/content/10.1101/2020.10.28.20221630v1https://www.medrxiv.org/content/10.1101/2020.10.28.20221630v1BCG+SoC administration resulted in a significantly higher percentage of patients with favorable outcomes than did SoC...The study shows that BCG is a safe, cost-effective treatment that can be introduced as a standard of care in patients with moderate Covid-19 ...director@haffkineinstitute.org
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312021-09-21AsiaIndiaStudy to Evaluate the Effectiveness of BCG vaccine in Reducing Morbidity and Mortality in Elderly individuals in COVID-19 Hotspots in India Indian Council of Medical Research BCG-Serum Institute of IndiaClosed to Recruitment of Participants 6 months post vaccination 6 months post vaccination N/AElderly 60 – 95 years of age residing in designated red and orange zones (hotspots) for SARS-Cov2 infection1450CTRI/2020/06/025854http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=44078&EncHid=&userName=BCGhttps://www.outlookindia.com/magazine/story/india-news-no-underreporting-all-the-missing-links-will-be-answered/303328pcorchids@gmail.com
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322022-07-15AsiaIndiaBCG Vaccine in Reducing Morbidity and Mortality in Elderly Individuals in COVID-19 HotspotsTuberculosis Research Centre, India
ICMR-National Institute for Research in Tuberculosis, Chennai, Tamil Nadu		BCG vaccine (Freeze-dried) manufactured by Serum Institute of IndiaCompleted

Has results: BCG could protect		July 1, 2020September 30, 2021September 30, 20213Elderly individuals 60 years - 80 years of age with general good health2175NCT04475302https://clinicaltrials.gov/ct2/show/NCT04475302https://doi.org/10.1371/journal.pone.0258743https://doi.org/10.1016/j.ijid.2021.07.041https://advances.sciencemag.org/content/7/32/eabg7181https://www.medrxiv.org/content/10.1101/2020.10.22.20217471v1

https://doi.org/10.1016/j.ijid.2021.07.041

https://advances.sciencemag.org/content/7/32/eabg7181
BCG vaccination was associated with enhanced innate and adaptive memory cell subsets, as well as total antibody levels in elderly individuals, suggesting its potential utility in SARS-Cov2 infection by enhancing heterologous immunity.

•BCG vaccination induces significantly enhanced frequencies of DC subsets
•BCG vaccination induces diminished plasma levels of type I interferons but increased levels of type III interferons
•BCG vaccination can potentially boost immune responses in a non -specific or off-target manner in these elderly individuals.		sbabu@nirt.res.in
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332022-10-18AsiaIndiaTo study the effect of BCG vaccine in Reducing the Incidence and severity of COVID-19 in the high-risk population Indian Council of Medical Research Open to Recruitment

Has results: BCG could protect
2YearsN/AHigh-risk groups which include: adults (Male and female ≥18 to 60 years) with underlying medical conditions,800CTRI/2020/07/026668http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=45677&EncHid=&userName=BCGhttps://link.springer.com/article/10.1007/s40121-022-00703-yThere was no significant difference in the incidence rates of cartridge-based nucleic acid amplification test (CB-NAAT) positive COVID-19 infection [odds ratio (OR) 1.08, 95% confidence interval (CI) 0.54–2.14] in the two groups, but the BCG arm showed a statistically significant decrease in clinically diagnosed (symptomatic) probable COVID-19 infections (OR 0.38, 95% CI 0.20–0.72). Compared with the BCG arm, significantly more patients developed severe COVID-19 pneumonia (CB-NAAT positive) and required hospitalisation and oxygen in the placebo arm (six versus none; p = 0.03). One patient belonging to the placebo arm required intensive care unit (ICU) stay and died. BCG had a protective efficacy of 62% (95% CI 28–80%) for likely symptomatic COVID-19 infection.drsanjeevsinha@gmail.com
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342020-10-08AsiaIndiaProtective effect of re-vaccination with BCG against COVID-19 in healthcare workers – A Pilot Study SGT University Budhera Gurugram Open to Recruitment 2020-09-151YearsN/AHealthcare workers400CTRI/2020/09/027684http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=47179&EncHid=&userName=BCGhod.tbchest@sgtuniversity.org
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352022-01-29AsiaTaiwanPrevention of Acute Respiratory Infection in Taiwanese Institutionalized ElderlyChang-Hua Hospital
Harvard Medical School		BCG-JapanNot yet recruitingJanuary 2022April 2022July 20222,3Clients of a long-term care facility
55-85 years old		830NCT04938323https://clinicaltrials.gov/ct2/show/NCT04938323ximena_tovar@hms.harvard.edu, meredith_brooks@hms.harvard.edu
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362021-08-09Middle EastIranInvestigating the Effect of BCG Vaccine on Preventing COVID-19 Infection in Healthcare Staff Exposed to SARS-CoV-2Shiraz University of Medical SciencesRecruitment complete2020-06-042021-06-053Healthcare workers500IRCT20200411047019N1https://www.irct.ir/trial/47279pourabbasb@sums.ac.ir
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372022-10-20AfricaEgyptApplication of BCG Vaccine for Immune-prophylaxis Among Egyptian Healthcare Workers During the Pandemic of COVID-19Ain Shams UniversityDanish strainUnknownApril 20, 2020October 1, 2020December 1, 20203Healthcare workers900NCT04350931https://clinicaltrials.gov/ct2/show/NCT04350931dr.imangalal@gmail.com, dr.fatma_ebeid@yahoo.com
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382022-10-20AfricaEgyptOutcome of COVID-19 Cases Based on Tuberculin Test: Can Previous BCG Alter the Prognosis?Assiut UniversityTuberculin testUnknownApril 11, 2020June 16, 2020June 30, 2020N/ACOVID-19 positive cases100NCT04347876https://clinicaltrials.gov/ct2/show/NCT04347876aliaehussein@gmail.com
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392022-05-14AfricaSouth AfricaBCG Vaccination for Healthcare Workers in COVID-19 PandemicTASK Applied ScienceBCG-Vaccin SSI [Statens Serum Institut], Danish strain 1331Completed

Has results: BCG doesn't protect		May 4, 2020January 2, 2022January 2, 20223Healthcare workers1000NCT04379336https://clinicaltrials.gov/ct2/show/NCT04379336https://twitter.com/j_sato/status/1281627299306041344?s=20https://bhekisisa.org/featured/2020-06-13-unions-activists-call-for-cape-town-covid-19-clinical-trial-to-be-stopped/https://task.org.za/bcg/https://ssrn.com/abstract=4011889

https://www.sciencedirect.com/science/article/pii/S2589537022001444		(2022/01/22 Jun)
About half of the participants have latent tuberculosis, and during the period, both new people with latent tuberculosis and people without latent tuberculosis have emerged, suggesting that the tubercle bacillus is almost routinely spread. If that is the case, BCG is unlikely to have any additional effect. Even against tuberculosis, in a high endemic country, BCG is not likely to have had significant results.

(2022/01/22 Chika)
Note that 68% of the 1000 participants dropped out due to covid19 vaccination.		dr.caryn@task.org.za, regulatory@task.org.za
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402020-08-28AfricaTunisiaCovid-19 In Tunisia: An Observational Cross-Sectional Registry Study (CONNAITRE)Eshmoun Clinical Research CentreWithdrawn (The sponsor decided to withdraw the study for funding reasons.)May 15, 2020July 15, 2020July 15, 2020N/ACOVID-19 (+), inpatient or outpatient, confirmed by PCR test
COVID-19 (-) confirmed by PCR test having been in contact with COVID-19 (+)		400NCT04384614https://clinicaltrials.gov/ct2/show/study/NCT04384614
agnes.hamzaoui@rns.tn
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412022-11-23AfricaCabo Verde, Guinea-Bissau, MozambiqueBCG to Reduce Absenteeism Among Health Care Workers During the COVID-19 Pandemic (EDCTP)University of Southern Denmark
Institute of Hygiene and Tropical Medicine, NOVA University, Lisbon, Portugal		BCG-Denmark, AJ Vaccines,Danish strain 1331CompletedDecember 3, 2020July 13, 2022July 13, 20224Healthcare workers668NCT04641858https://clinicaltrials.gov/ct2/show/study/NCT04641858https://observador.pt/2020/06/01/investigacao-vai-estudar-efeitos-da-bcg-no-absentismo-dos-profissionais-de-saude-nos-palop/cbenn@health.sdu.dk, ifronteira@ihmt.unl.pt
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422022-07-15South PacificAustralia (and Netherlands,Spain,Brazil,UK)BCG Vaccination to Protect Healthcare Workers Against COVID-19 (BRACE)Murdoch Childrens Research Institute
Royal Children's Hospital		Danish strain 1331
BCG Denmark		CompletedMarch 30, 2020November 10, 2021May 27, 20223Healthcare workers6828NCT04327206https://clinicaltrials.gov/ct2/show/NCT04327206https://www.nature.com/articles/s41541-021-00421-5https://bmjopen.bmj.com/content/11/10/e052101https://www.mcri.edu.au/news/10m-grant-enables-mcris-bcg-vaccine-trial-expand-internationallyhttps://onlinelibrary.wiley.com/doi/full/10.1002/cti2.1387nigel.curtis@rch.org.au
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432022-08-29South PacificAustralia
Investigating COVID-19 Vaccine Immunity in Children in the Melbourne Infant Study of BCG for Allergy and Infection Reduction (COSI BAIR)		Murdoch Childrens Research Institute-Active, not recruitingJanuary 2022December 31, 2022December 31, 20234Age between five and eleven years

Participant who was randomised in the MIS BAIR trial, and
・Was randomly allocated to receive and received BCG as part of the MIS BAIR trial, OR,
・Was randomly allocated to not receive and did not receive BCG;		60NCT05168709https://clinicaltrials.gov/ct2/show/NCT05168709nigel.curtis@rch.org.au,
andres.noe@mcri.edu.au
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442020-09-21South PacificAustraliaA Placebo-Controlled Study to Evaluate the effect of the recombinant Bacillus Calmette–Guérin (BCG) vaccine VPM1002 on the Incidence or Disease Severity of SARS-COV-2/COVID-19 Among High-Risk Participants in AustraliaSerum Institute of India Pvt Ltd
Accelagen Pty Ltd		VPM1002Withdrawn(The Sponsor has elected to cease the study prior to commencing recruitment for commercial reasons.)2020-06-302021-03-313• Health care workers
• Other high-risk participants who are aged >/= 65 years or aged >/= 18 years with co-morbidities		3468ACTRN12620000707965https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000707965mark.bloch@holdsworthhouse.com.au, VPM1002_covid19@accelagen.com.au
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452021-01-24AmericasUSABCG vaccination history associates with decreased SARS-CoV-2 seroprevalence across a diverse cohort of health care workersCedars-Sinai Medical Center, Los Angeles, CA, USAHas results: BCG could protectMay 2020June 2020Healthcare workers6201https://www.jci.org/articles/view/145157https://www.cedars-sinai.org/newsroom/study-tb-vaccine-linked-to-lower-risk-of-contracting-covid-19/https://www.jci.org/articles/view/145157A history of BCG vaccination was associated with a decrease in the seroprevalence of anti–SARS-CoV-2 IgG and a lower number of participants who self-reported experiencing COVID-19–related clinical symptoms in this cohort of HCWs. Therefore, large randomized, prospective clinical trials of BCG vaccination are urgently needed to confirm whether BCG vaccination can confer a protective effect against SARS-CoV-2 infection.moshe.arditi@cshs.org
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462021-04-14AsiaChinaChildhood Bacille Calmette-Guerin Vaccination and Its Association With Less Severe COVID-19 PneumoniaWuhan Pulmonary Hospitalretrospective studyHas results: BCG could protectFebruary 1, 2020March 30, 2020COVID-19 patients428https://doi.org/10.1016/j.amepre.2021.02.025https://doi.org/10.1016/j.amepre.2021.02.025The current investigation suggests that BCG vaccination in children is associated with less severe COVID-19 pneumonia, milder liver function deficiency, and a lower death rate when compared with unvaccinated patients. This conclusion is supported after controlling for major confounding factors including age, sex, ethnicity, BMI, the pandemic curve, demography, diabetes, and other underlying medical conditions.
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472021-01-24AsiaIndiaRole of BCG Vaccination in prevention of COVID-19 infection amongst the health
care workers 		Noida District Hospital and Superspecialilty PG Teaching institute (SSPGTI) hospital, NoidaBCG vaccine(Danish 1331 strain)Has results: BCG could protectMay 2020August 2020Healthcare workers210https://www.worldwidejournals.com/indian-journal-of-applied-research-(IJAR)/fileview/role-of-bcg-vaccination-in-prevention-of-covid19-infection-amongst-the-health-care-workers_November_2020_7179480964_4311804.pdfhttps://timesofindia.indiatimes.com/city/noida/covid-fight-study-to-find-tuberculosis-vaccines-role/articleshow/79123299.cmshttps://www.amarujala.com/delhi-ncr/ambulance-workers-to-be-given-bcg-injections-national-health-mission-issues-letterhttps://www.worldwidejournals.com/indian-journal-of-applied-research-(IJAR)/fileview/role-of-bcg-vaccination-in-prevention-of-covid19-infection-amongst-the-health-care-workers_November_2020_7179480964_4311804.pdfAdditional dose of BCG vaccination after the age of 20 year in healthcare workers engaged in care of admitted COVID-19 patients has a protective role since the COVID status of the patients attending hospitals for any other ailments is not known routine BCG immunization of the medical staff is recommended
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482020-11-27AsiaIndiaInnate Immune Response Modulation and Resistance to SARS-CoV-2 infection: A Prospective Comparative Cohort Study in High Risk Healthcare WorkersManashi Chakrabarti Foundationheat killed Mycobacterium w (Mw)Healthcare workers96CTRI 2020/10/028326 ?https://www.medrxiv.org/content/10.1101/2020.10.20.20214965v1https://vaccine.icmr.org.in/mw-in-covid19https://www.medrxiv.org/content/10.1101/2020.10.20.20214965v1foundationforcure@gmail.com
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492021-08-25Middle EastUAEEffectiveness of booster BCG vaccination in preventing Covid-19 infectionEmirates International Hospitalbooster BCG(Serum Institute of India PVT.LTD. Hadaspar India)Has results: BCG could protectMarch 2020June 2020Healthcare workers280https://doi.org/10.1080/21645515.2021.1956228https://www.medrxiv.org/content/10.1101/2020.08.10.20172288v1https://doi.org/10.1080/21645515.2021.1956228Our findings demonstrated the potential effectiveness of the booster BCG vaccine, specifically the booster in preventing Covid-19 infections in an elevated-risk healthcare population.Bardia.Amirlak@UTSouthwestern.edu
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502021-10-26Middle EastTurkeyEffectiveness of booster BCG vaccination in preventing Covid-19 infectionNigde Omer Halisdemir UniversityHas results: BCG could protectCOVID-19 patients76https://doi.org/10.1002/jmv.27414https://doi.org/10.1002/jmv.27414COVID-19 patients with positive TST showed a significantly higher rate of mild disease than those with negative TST. It is possible to say that TST positivity is favorably associated with the course of COVID-19.ukayabas@gmail.com
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512020-11-27Middle EastJordanCOVID-19 outbreak in Jordan: Epidemiological features, clinical characteristics, and laboratory findingsJordan University of Science and Technology (JUST)March 2020April 2020Patients with laboratory-confirmed COVID-19 infection by RT-PCR in the North of Jordan admitted between March 15 and April 2, 202081https://www.sciencedirect.com/science/article/pii/S2049080120302016https://www.sciencedirect.com/science/article/pii/S2049080120302016samrah@just.edu.jo, awalmistarehi18@med.just.edu.jo
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522021-12-07AfricaMoroccoSARS-Cov 2 infection and anti-tuberculosis immunity: temporal association or real protective role?Faculty of Medicine and Pharmacy of Tangier FMPT, Abd Elmalek Essadi University (AEU)Has results: BCG could protect240https://www.researchsquare.com/article/rs-1129122/v1https://www.researchsquare.com/article/rs-1129122/v1We found that our control group had a high value of IDR positivity, with a percentage of IDR positivity to tuberculin was higher in non-infected patients (67.2%) than the infected patients, (p ˂0.001). This suggests that immunity to IDR is a protective factor against coronavirus disease (Table 4).
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532020-06-06VietnamVietnam National Lung Hospital
National Institute Of Hygiene And Epidemiology		suspendsmedical workers and patients800https://e.vnexpress.net/news/news/vietnam-suspends-tb-vaccine-trial-for-covid-19-4110607.htmlhttps://vnexplorer.net/vietnam-seeking-to-work-out-bcg-vaccine-and-covid-19-connection-a202025829.htmlhttps://www.thestar.com.my/news/regional/2020/04/22/vietnam-to-study-effectiveness-of-tuberculosis-vaccine-in-fighting-covid-19
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542020-06-11USADr. Denise Faustman, director of immunobiology at Massachusetts General Hospital in BostonTokyo strain ?Healthcare workers4000https://www.statnews.com/2020/04/14/decades-old-tb-vaccine-attracts-attention-and-skepticism-as-a-potential-weapon-against-covid-19/https://www.nytimes.com/2020/04/03/health/coronavirus-bcg-vaccine.htmlhttp://www.bcgandautoimmunity.org/
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552020-06-06GermanyMax Planck Institute for Infection Biology in BerlinVPM1002,Genetically modified BCG2000https://www.dw.com/en/can-a-tuberculosis-vaccine-help-combat-covid-19/a-53388220https://www.mpg.de/14610776/immune-boost-corona-virushttps://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/serum-institute-to-test-if-tb-vaccine-vpm1002-is-effective-against-covid-19/articleshow/74800246.cmsgrode@vakzine-manager.de
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562020-06-06UruguayAlejandro Chabalgoity, director of the Department of Biotechnological Development of the Institute of Hygiene of the Udelar School of Medicine2000https://www.montevideo.com.uy/Mujer-y-salud/Uruguay-realizara-ensayo-clinico-para-estudiar-efectos-de-la-vacuna-BCG-contra-el-COVID-19-uc751679https://www.lr21.com.uy/comunidad/1427749-alejandro-chabalgoity-esnsayos-clinicos-vacuna-bcg-coronavirus
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572020-07-23TaiwanHarvard global health researcher and Chief Abundance Partner, Dr. Megan MurrayTokyo strainLooking for fundingAugust 2020https://twitter.com/j_sato/status/1286093661311123456?s=20https://www.abundance.org/covid/
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582020-06-06PeruHarvard global health researcher and Chief Abundance Partner, Dr. Megan MurrayLooking for fundinghttps://www.abundance.org/covid/Emily_Bahnsen@hms.harvard.edu
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592020-06-06Irelandhttps://www.irishexaminer.com/breakingnews/ireland/bcg-could-be-first-approved-vaccine-for-covid-19-993442.htmlhttps://www.urotoday.com/video-lectures/covid-19-and-genitourinary-cancers/video/1716-the-bactir-trial-bcg-vaccination-against-sars-cov-2-to-protect-health-care-workers-by-enhanced-trained-immune-responses.htmlhttps://twitter.com/urodocash?lang=en
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