COVID-19: BCG As Therapeutic Vaccine, Transmission Limitation, and Immunoglobulin Enhancement (BATTLE)

November 27, 2023 updated by: Leonardo Oliveira Reis, University of Campinas, Brazil
To date, there is no vaccine or treatment with proven efficiency against COVID-19, and the transmissibility of the SARS-CoV-2 virus can be inferred by its identification in the oro-nasopharynx. The bacillus Calmette Guérin (BCG) has the potential for cross-protection against viral infections. This study evaluates the impact of previous (priming effect, from the titer of anti-BCG interferon-gamma) or current BCG exposure (boost with intradermal vaccine) on 1) clinical evolution of COVID-19; 2) elimination of SARS-CoV-2 at different times and disease phenotypes; and 3) seroconversion rate and titration (anti-SARS-CoV-2 IgA, IgM, and IgG).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective, randomized, double-blind, multicentre study with international design collaboration with central clinical and mechanistic outcomes with public health implications both epidemiological and therapeutic in the context of the pandemic of COVID-19, an emerging disease, which quickly disrupted health services including Brazil's Unified Health System (SUS), as well as the entire productive force and economy worldwide. Because it is recent, the basic evidence related to infection, such as incubation period, time of transmissibility, and seroconversion, is little known and the proposal's goals have the potential to redirect the vaccine. Exploring bacillus Calmette Guerin (BCG) that presents significant potential for immune activation, with recognized safety in decades of previous experience and clear potential in the context under analysis, with low cost and available, ensuring wide accessibility, especially in the context of SUS, on which it depends especially the most vulnerable portion of the Brazilian population, notably in the COVID-19 pandemic. Non-specific effects of BCG caused by monocyte epigenetic reprogramming may result in increased production of pro-inflammatory cytokines, conferring innate (trained) immunity and protection against viral infections, including SARS-CoV-2 with the potential to positively impact clinical evolution, viral elimination, and seroconversion of COVID-19 patients.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Campinas, SP, Brazil, 13083-887
        • Hospital das Clínicas Unicamp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • > 18 years of age;
  • laboratory or clinical-epidemiological confirmation of COVID-19 (history of close or home contact with a laboratory-confirmed case who has fever or at least one of the respiratory signs or symptoms, in the last 14 days after contact, and for which it was not possible to carry out the specific laboratory investigation)

Exclusion Criteria:

  • Immunosuppressed patients of any kind;
  • Pregnant women;
  • More than 14 days from the onset of symptoms;
  • Not accept participation or non-signature of the IC;
  • Undiagnosed cases, suspected or probable.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BCG vaccine
BCG Group (n = 200): 0.1 ml of lyophilized, live, and attenuated BCG intradermal vaccine, containing between 2 and 8 x 1.000.000 C.F.U in a single dose.
Biological: BCG
0.1 ml of lyophilized, live and attenuated intradermal BCG vaccine, containing between 2 and 8 x 1.000.000 C.F.U in a single dose
Other Names:
  • Calmette Guerin bacillus
Placebo Comparator: Placebo
Placebo group (n = 200): 0.9% saline solution in the same volume as BCG vaccine in a single dose.
Biological: Placebo
0.9% saline in the same volume as the BCG vaccine in a single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical evolution of COVID-19
Time Frame: 45 days of symptoms onset or diagnosis
Classified as mild, moderate and severe
45 days of symptoms onset or diagnosis
SARS-CoV-2 elimination
Time Frame: 7 days of symptoms onset or diagnosis
Virus detection by PCR
7 days of symptoms onset or diagnosis
Seroconversion rate and titration
Time Frame: 7 days of symptoms onset or diagnosis
Titration of anti SARS-CoV-2 IgA, IgM and IgG
7 days of symptoms onset or diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local and systemic adverse events to BCG vaccination
Time Frame: 3 months
Classified according to type and severity
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS-CoV-2 elimination
Time Frame: 21 days of symptoms onset or diagnosis
Virus detection by PCR
21 days of symptoms onset or diagnosis
Seroconversion rate
Time Frame: 21 days of symptoms onset or diagnosis
Titration of anti SARS-CoV-2 IgA, IgM and IgG
21 days of symptoms onset or diagnosis
SARS-CoV-2 elimination
Time Frame: 45 days of symptoms onset or diagnosis
Virus detection by PCR
45 days of symptoms onset or diagnosis
Seroconversion rate and titration
Time Frame: 45 days of symptoms onset or diagnosis
Titration of anti SARS-CoV-2 IgA, IgM and IgG
45 days of symptoms onset or diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico
Paulínia Municipal Hospital

Investigators

  • Principal Investigator: Leonardo O Reis, MD, PhD, UroScience, University of Campinas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

June 4, 2022

Study Completion (Actual)

August 2, 2023

Study Registration Dates

First Submitted

April 27, 2020

First Submitted That Met QC Criteria

April 28, 2020

First Posted (Actual)

April 30, 2020

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-19 BATTLE trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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