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Performance Evaluation of BCG Vaccination in Healthcare Personnel to Reduce the Severity of SARS-COV-2 Infection

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ClinicalTrials.gov Identifier: NCT04362124
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Universidad de Antioquia

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.


Condition or disease Intervention/treatment Phase
COVID-19 Biological: vaccine BCG Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Supportive Care
Official Title: Performance Evaluation of BCG Vaccination in Healthcare Personnel to Reduce the Severity of SARS-COV-2 Infection in Medellín, Colombia, 2020
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: vaccine BCG

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

Placebo Comparator: Placebo

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
A single dose intradermal application of normal saline solution.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Secondary outcome [ Time Frame: From date to diagnosis to 1 month after ]
    Incidence of severe or critical infection in COVID-19 cases

  2. Secondary outcome [ Time Frame: From date to diagnosis to 1 month after ]
    Lethality of the infection in both groups

  3. Secondary outcome [ Time Frame: From date of randomization to 7 day of the study ]
    Assess the safety (frequency, seriousness, and severity of adverse events) of BCG vaccination

  4. Secondary outcome [ Time Frame: At baseline evaluation ]
    Prevalence of SARS-Cov-2 infection



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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  • 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)

Exclusion Criteria

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04362124


Contacts
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Contact: Juan C Cataño, MD.MI.ID 314-617-5507 kataju@hotmail.com
Contact: Liliana Lopez, BSc.MSc +574 2196506 liliana.lopez@pecet-colombia.org

Locations
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Colombia
Program for Research and Control in Tropical Diseases - PECET
Medellín, Antioquia, Colombia, 1226
Sponsors and Collaborators
Universidad de Antioquia
Investigators
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Principal Investigator: Juan C cataño, MD.MI.ID infectious medicine doctor
Additional Information:
Publications:

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Responsible Party: Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT04362124    
Other Study ID Numbers: PEC03_2020
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidad de Antioquia:
coronavirus
BCG
COVID-19
SARS-COV-2
Additional relevant MeSH terms:
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Infection
BCG Vaccine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs