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

NCT04369794 | Completed Phase 4 DMC

• 1 other identifier: COVID-19 BATTLE trial
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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).

Conditions

COVID-19; Therapeutic Vaccine; BCG; SARS-CoV 2; Transmission

Keywords

BCG; Therapeutic Vaccine; COVID-19; SARS-CoV 2; Interferon Gamma; Immunoglobulin; Immunemodulation; Transmission

Outcome Measures

Primary Outcomes (3)

• Clinical evolution of COVID-19

  Classified as mild, moderate and severe

  45 days of symptoms onset or diagnosis

• SARS-CoV-2 elimination

  Virus detection by PCR

  7 days of symptoms onset or diagnosis

• Seroconversion rate and titration

  Titration of anti SARS-CoV-2 IgA, IgM and IgG

  7 days of symptoms onset or diagnosis

Secondary Outcomes (1)

• Local and systemic adverse events to BCG vaccination

  3 months

Other Outcomes (4)

• SARS-CoV-2 elimination

  21 days of symptoms onset or diagnosis

• Seroconversion rate

  21 days of symptoms onset or diagnosis

• SARS-CoV-2 elimination

  45 days of symptoms onset or diagnosis

Study Arms (2)

BCG vaccine

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Placebo group (n = 200): 0.9% saline solution in the same volume as BCG vaccine in a single dose.

Biological: Placebo

Interventions

BCG BIOLOGICAL

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

Also known as: Calmette Guerin bacillus

BCG vaccine

Placebo BIOLOGICAL

0.9% saline in the same volume as the BCG vaccine in a single dose

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Campinas, Brazil: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Paulínia Municipal Hospital: collaborator

Study Sites (1)

Hospital das Clínicas Unicamp

Campinas, São Paulo, 13083-887, Brazil

Location

Related Publications (3)

• Jalalizadeh M, Leme PAF, Buosi K, Dionato FAV, Dal Col LSB, Giacomelli CF, Reis LO. Healthcare Workers (HCWs) and non-HCWs reaction to Bacillus Calmette-Guerin (BCG) in the BATTLE trial. Vaccine. 2023 Oct 20;41(44):6599-6606. doi: 10.1016/j.vaccine.2023.09.031. Epub 2023 Sep 22.

  PMID: 37743116 DERIVED

• Dionato FAV, Jalalizadeh M, Buosi K, Visacri MB, Dal Col LSB, Giacomelli CF, Leme PAF, Maia CL, Moriel P, Reis LO. BCG vaccine safety in COVID-19 convalescent adults: BATTLE a randomized controlled trial. Vaccine. 2022 Jul 30;40(32):4603-4608. doi: 10.1016/j.vaccine.2022.06.039. Epub 2022 Jun 20.

  PMID: 35738969 DERIVED

• Jalalizadeh M, Buosi K, Dionato FAV, Dal Col LSB, Giacomelli CF, Ferrari KL, Pagliarone AC, Leme PAF, Maia CL, Yadollahvandmiandoab R, Trinh QD, Franchini KG, Bajgelman MC, Reis LO. Randomized clinical trial of BCG vaccine in patients with convalescent COVID-19: Clinical evolution, adverse events, and humoral immune response. J Intern Med. 2022 Oct;292(4):654-666. doi: 10.1111/joim.13523. Epub 2022 Jun 3.

  PMID: 35599154 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

BCG Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; 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

• Leonardo O Reis, MD, PhD

  UroScience, University of Campinas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Livre Docente

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 30, 2020
• Study Start: October 1, 2020
• Primary Completion: June 4, 2022
• Study Completion: August 2, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)