NCT04461379

Prevention, Efficacy and Safety of BCG Vaccine in COVID-19 Among Healthcare Workers

Status unknown Phase 3 Last updated 13 November 2020

What this trial tests

Phase 3 trial testing BCG vaccine in BCG in 908 participants. Status unknown.

Timeline

21 July 2020

Primary endpoint
1 January 2021

1 January 2021

Quick facts

Lead sponsor	Hospital Universitario Dr. Jose E. Gonzalez
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	908
Start date	21 July 2020
Primary completion	1 January 2021
Estimated completion	1 January 2021
Sites	1 location across Mexico

Drugs / interventions tested

• BCG vaccine — full drug profile →
• Placebo

Conditions studied

• BCG — all drugs for BCG →
• COVID-19 — all drugs for COVID-19 →
• SARS-CoV2 — all drugs for SARS-CoV2 →
• Corona Virus Infection — all drugs for Corona Virus Infection →

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Who can join

18 and older, any sex, with BCG or COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In Mexico the total number of confirmed cases of COVID-19 is 232, 000 and 28,510 deaths. Health workers are at high risk of COVID-19 infection. Their absence from work dramatically limits the ability to contain the disease. There is currently no vaccine to prevent the disease. Since the introduction to the vaccination schedule of the Bacillus Calmette-Guerin (BCG) live attenuated vaccine directed towards tuberculosis prevention, a decrease in infant mortality has been reported, not related only to tuberculosis. BCG vaccine has been hypothesized to have a non-specific role towards other unrelated pathogens such as viruses that cause airway disease, with reduced morbidity and mortality. In murine as well as in human models it has been shown to decrease the incidence of acute respiratory influenza infections. Likewise, in countries with a high endemicity for tuberculosis, the BCG vaccine reduces the incidence of respiratory infections by up to 80% . In healthy subjects, the BCG vaccine increases the production of proinflammatory cytokines in monocytes. Likewise, it increases the epigenetic response, causing an increase in the transcription of genes important in the antimicrobial response, as well as an improvement in cellular function. This is the first national clinical trial to evaluate prospectively the effect that the BCG vaccine offers towards the prevention and reduction of severity in cases of COVID-19.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Protection against SARS-CoV-2 by BCG vaccination is not supported by epidemiological analyses.
   Hensel J, McAndrews KM, McGrail DJ, Dowlatshahi DP, et al · · 2020 · cited 57× · PMID 33110184 · DOI 10.1038/s41598-020-75491-x
2. The BCG Vaccine for COVID-19: First Verdict and Future Directions.
   Gonzalez-Perez M, Sanchez-Tarjuelo R, Shor B, Nistal-Villan E, et al · · 2021 · cited 50× · PMID 33763077 · DOI 10.3389/fimmu.2021.632478
3. An update review of globally reported SARS-CoV-2 vaccines in preclinical and clinical stages.
   Motamedi H, Ari MM, Dashtbin S, Fathollahi M, et al · · 2021 · cited 34× · PMID 34162141 · DOI 10.1016/j.intimp.2021.107763
4. The double-sided effects of Mycobacterium Bovis bacillus Calmette-Guérin vaccine.
   Li J, Zhan L, Qin C. · · 2021 · cited 34× · PMID 33495451 · DOI 10.1038/s41541-020-00278-0
5. Learning through a Pandemic: The Current State of Knowledge on COVID-19 and Cancer.
   Elkrief A, Wu JT, Jani C, Enriquez KT, et al · · 2022 · cited 33× · PMID 34893494 · DOI 10.1158/2159-8290.cd-21-1368
6. COVID-19 pandemic: SARS-CoV-2 specific vaccines and challenges, protection via BCG trained immunity, and clinical trials.
   Gong W, Aspatwar A, Wang S, Parkkila S, et al · · 2021 · cited 30× · PMID 34078215 · DOI 10.1080/14760584.2021.1938550
7. Principles and Challenges in anti-COVID-19 Vaccine Development.
   Strizova Z, Smetanova J, Bartunkova J, Milota T. · · 2021 · cited 29× · PMID 33524979 · DOI 10.1159/000514225
8. Ongoing Clinical Trials of Vaccines to Fight against COVID-19 Pandemic.
   Chakraborty C, Sharma AR, Bhattacharya M, Sharma G, et al · · 2021 · cited 19× · PMID 33728098 · DOI 10.4110/in.2021.21.e5