Performance Evaluation of BCG Vaccination in Healthcare Personnel to Reduce the Severity of COVID-19 Infection.

NCT04362124 | Withdrawn Phase 3 DMC

• 1 other identifier: PEC03_2020
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

COVID-19

Keywords

coronavirus; BCG; COVID-19; SARS-COV-2

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  Incidence of COVID-19 cases confirmed or probable in the study population

  From date of randomization to 360 day of the study

Secondary Outcomes (4)

• Secondary outcome

  From date to diagnosis to 1 month after

• Secondary outcome

  From date to diagnosis to 1 month after

• Secondary outcome

  From date of randomization to 7 day of the study

• Secondary outcome

  At baseline evaluation

Study Arms (2)

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.

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.

Other: Placebo

Interventions

vaccine BCG BIOLOGICAL

Performance evaluation of a single dose of BCG vaccine in reducing the severity of SARS-COV-2 infection compared to placebo, in healthcare personnel.

Also known as: BCG Liofilizada

vaccine BCG

Placebo OTHER

A single dose intradermal application of normal saline solution.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Universidad de Antioquia: lead

Study Sites (1)

Program for Research and Control in Tropical Diseases - PECET

Medellín, Antioquia, 0004, Colombia

Location

Related Publications (18)

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  PMID: 30564249 BACKGROUND

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  PMID: 157204 BACKGROUND

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Related Links

• official report of the coronavirus in colombia

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 Officials

• Juan C cataño, MD.MI.ID

  infectious medicine doctor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind trial. The blinding of the investigational vaccine will be maintained using an opaque label for the two products (vaccine and placebo). The subjects, who collect the data (e.g., investigator and coordinator) and who evaluate the data (e.g., statistician) will be blinded. One or more pharmacists/vaccine administrators designated from the facility will not be blinded. These designated unblinded individuals will maintain the blindness of the investigational vaccine and will not be involved in evaluating the safety of the subjects.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Study Start: August 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: November 1, 2021
• Last Updated: April 2, 2026

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)