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

NCT04461379 | Unknown Phase 3 DMC

• 1 other identifier: EN20-00011
• Study Type: interventional
• Target: 908
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

BCG; COVID-19; SARS-CoV2; Corona Virus Infection

Keywords

Healthcare workers

Outcome Measures

Primary Outcomes (8)

• Demonstrate COVID- 19 disease incidence among Health care workers:

  Cumulative incidence of infection in 6 months: disease defined as positive SARS-Cov-2 test (serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)

  During the 6 months study period

• Demonstrate cumulative incidence of hospitalization for COVID-19 among Health care workers:

  Cumulative incidence of hospitalization for COVID-19

  During the 6 months study period

• Demonstrate the Incidence of specific Antibodies against SARS-CoV-2 at 3 and 6 months in health care workers

  Incidence of specific Antibodies (IgG and IgM) against SARS-CoV-2 will be measured at 3 and 6 months

  During the 6 months study period

• Hospitalization of severe disease COVID-19

  Number of participants who needed hospitalization

  During the 6 months study period

• Oxygen supplementation in severe disease COVID-19

  Number of participants who Need for oxygen supplementation (nasal cannulas, masks, high flow oxygen) in hospitalized patients

  During the 6 months study period

• Need for intubation or non-invasive ventilation for the patient.

  Number of participants who Need for intubation or non-invasive ventilation in hospitalized patients

  During the 6 months study period

• Critical care admission with SARS-CoV2

  Number of participants in Critical care admission with SARS-CoV2 in hospitalized patients

  During the 6 months study period

• Mortality associated to progressive pulmonary disease

  Mortality associated to progressive pulmonary disease in hospitalized patients

  During the 6 months study period

Secondary Outcomes (9)

• Evaluate the safety of the vaccine by measuring the incidence rates of local and systemic adverse effects that occur after one month its application.

  1 month after vaccine/placebo application

• Calculate the incidence of COVID-19 complications

  During the 6 months study period

• Determine the mean days of hospitalization and days in intensive care unit by COIVD-19

  During the 6 months study period

• Calculate the cost associated with in-hospital medical care

  During the 6 months study period

• Determine the scores of the Clinical Prediction Rules associated with mortality using Sequential Organ Failure Assessment (SOFA score) at the patient's hospital admission:

  During the 6 months study period

Study Arms (2)

BCG Vaccine

EXPERIMENTAL

A single dose BCG vaccine intradermally 0.1 ml.

Biological: BCG vaccine

Placebo

PLACEBO COMPARATOR

A single dose intradermally 0.1 ml of NaCl 0.9% solution

Other: Placebo

Interventions

BCG vaccine BIOLOGICAL

A single dose BCG vaccine intradermally (deltoid region of the right arm) 0.1 ml, equivalent to 0.075 mg of attenuated Mycobacterium bovis . (Tokio 172 strain)

Also known as: Calmette-Guerin Bacillus vaccine

BCG Vaccine

Placebo OTHER

A single dose intradermally ((deltoid region of the right arm) 0.1 ml of NaCl 0.9% solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Health workers who are working onsite in patients' areas with COVID-19
• Age \> 18 years
• Negative specific IgG and IgM antibodies test result for SARS CoV-2 before the enrollment.
• Provide a signed and dated informed consent form

You may not qualify if:

• Age \<18 years
• Positive test for specific antibodies IgG and IgM antibodies result for SARS Cov-2
• Primary or secondary immunosuppression
• Use of immunosuppression drugs, use of hydroxychloroquine, cloroquine, Azithromycin, Lopinavir/ritonavir, Ivermectin or any other drug used to treat patients COVID-19 before the enrollment.
• Chemotherapy treatment
• Presence of antibodies IgA, IgM, IgG against SARS-CoV-2
• Pregnancy or breastfeeding
• Missing informed consent form
• Fever \> 38° in the previous 24 hours
• Any BCG vaccine contraindication
• History of previous allergy to the components of the vaccine
• Already part of any other trial
• Previous or active tuberculosis (TB) disease
• Another vaccine administrated 4 months before the start of the trial.
• Any underlying history of malignancy or lymphoma.

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hospital Universitario "José E. González"

Monterrey, Nuevo León, 64460, Mexico

Location

Related Links

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MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

BCG Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, researchers (including members of the research team that will assess outcomes), and treating physicians or health personnel (should the patient require in-hospital management) will be blinded to the treatment group to which the patients were randomized. Only the personnel who apply the vaccine will not be blinded to the treatment group to which the patients were randomized (this personnel will not have any further contact with the patients or provide any other type of patient care).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Endocrinology Division, Facultad de Medicina

Model Details: A randomized double-blinded clinical trial, using computer software, participants will be allocated between two groups: Intervention: BCG vaccine intradermally 0.1 ml, equivalent to 0.075 mg of attenuated Mycobacterium bovis. (Tokio 172 strain). The application technique is based on the National Vaccination Manual version 2017. Comparator: Placebo, intradermally 0.1 ml of NaCl 0.9%

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 8, 2020
• Study Start: July 21, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)