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

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ClinicalTrials.gov Identifier: NCT04369794
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : August 7, 2020
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Instituto de Infectologia Emílio Ribas
Pontifícia Universidade Católica de Campinas, PUC-Campinas
Faculty of Medicine of Ribeirão Preto (FMRP-USP)
Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
Federal University of São Paulo
State Hospital Dr. Leandro Franceschini, Sumaré, Unicamp
Paulinia Municipal Hospital
Information provided by (Responsible Party):
Leonardo Oliveira Reis, University of Campinas, Brazil

Tracking Information
First Submitted Date  ICMJE April 27, 2020
First Posted Date  ICMJE April 30, 2020
Last Update Posted Date August 7, 2020
Estimated Study Start Date  ICMJE August 10, 2020
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2020)
  • Clinical evolution of COVID-19 [ Time Frame: 45 days of symptoms onset or diagnosis ]
    Classified as mild, moderate and severe
  • SARS-CoV-2 elimination [ Time Frame: 7 days of symptoms onset or diagnosis ]
    Virus detection by PCR
  • Seroconversion rate and titration [ Time Frame: 7 days of symptoms onset or diagnosis ]
    Titration of anti SARS-CoV-2 IgA, IgM and IgG
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2020)
Local and systemic adverse events to BCG vaccination [ Time Frame: 3 months ]
Classified according to type and severity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 28, 2020)
  • SARS-CoV-2 elimination [ Time Frame: 21 days of symptoms onset or diagnosis ]
    Virus detection by PCR
  • Seroconversion rate [ Time Frame: 21 days of symptoms onset or diagnosis ]
    Titration of anti SARS-CoV-2 IgA, IgM and IgG
  • SARS-CoV-2 elimination [ Time Frame: 45 days of symptoms onset or diagnosis ]
    Virus detection by PCR
  • Seroconversion rate and titration [ Time Frame: 45 days of symptoms onset or diagnosis ]
    Titration of anti SARS-CoV-2 IgA, IgM and IgG
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE COVID-19: BCG As Therapeutic Vaccine, Transmission Limitation, and Immunoglobulin Enhancement
Official Title  ICMJE COVID-19: BCG As Therapeutic Vaccine, Transmission Limitation, and Immunoglobulin Enhancement
Brief Summary 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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19
  • Therapeutic Vaccine
  • BCG
  • SARS-CoV 2
  • Transmission
Intervention  ICMJE
  • 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 Name: Calmette Guerin bacillus
  • Biological: Placebo
    0.9% saline in the same volume as the BCG vaccine in a single dose
Study Arms  ICMJE
  • Active Comparator: BCG vaccine
    BCG Group (n = 500): 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.
    Intervention: Biological: BCG
  • Placebo Comparator: Placebo
    Placebo group (n = 500): 0.9% saline solution in the same volume as BCG vaccine in a single dose.
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 28, 2020)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2023
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karen L Ferrari, PhD +55 19 3521 7481 karenferrari@gmail.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04369794
Other Study ID Numbers  ICMJE COVID-19 BATTLE trial
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Leonardo Oliveira Reis, University of Campinas, Brazil
Study Sponsor  ICMJE University of Campinas, Brazil
Collaborators  ICMJE
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Instituto de Infectologia Emílio Ribas
  • Pontifícia Universidade Católica de Campinas, PUC-Campinas
  • Faculty of Medicine of Ribeirão Preto (FMRP-USP)
  • Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
  • Federal University of São Paulo
  • State Hospital Dr. Leandro Franceschini, Sumaré, Unicamp
  • Paulinia Municipal Hospital
Investigators  ICMJE
Principal Investigator: Leonardo O Reis, MD, PhD UroScience, University of Campinas
PRS Account University of Campinas, Brazil
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP