Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to COVID-19 Infection in Healthcare Personnel (Bacmune)

Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial on the Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to SARS-CoV-2 Infection in Healthcare Personnel

The purpose of this trial is to assess the effect of immunotherapy with the bacterial preparation MV130 on the spread and course of SARS-CoV-2 infection in highly exposed subjets, as is the case with healthcare personnel.

Study Overview

• Status: Withdrawn
• Conditions: Covid19
• Intervention / Treatment: Biological: BACMUNE (MV130); Other: Placebo

Detailed Description

This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy of BACMUNE (MV130) in the prevention of disease due to SARS-VoC-2 infection in healthcare personnel

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Ciudad de México, Mexico, Ciudad de México
    • Instituto Nacional de Enfermedades Respiratorias (INER)
  • Pachuca de Soto, Mexico, 42070
    • Hospital General de Pachuca
  • San Luis Potosí, Mexico
    • Hospital de Ciudad Valles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Health personnel who are or have been in contact with patients with disease due to SARS-COV-2 infection within the last 14 days before randomization.
• Negative result for test against COVID-19.
• Subjects who have given informed consent.
• Men or women aged between 18 and 65 years, both included.
• Subjects who have a smartphone where they can load an APP for monitoring the symptoms.

Exclusion Criteria:

• Subjects who are participating in another clinical trial.
• Subjects who are unable to offer cooperation and/or have serious psychiatric disorders.
• Subjects who are allergic to any of the compounds included into MV130.
• Subjects who present contraindications to any of the components of BACMUNE (MV130).
• Subjects who are not able to comply with the dosage regimen.
• Subjects with immunodeficiencies.
• Subjects with malignancy involving the bone marrow or lymphoid systems.
• Pregnant or suspected pregnant women and breastfeeding women.
• Subjects in medical treatment that affects the response of the immune system. It includes corticosteroids (equal to or more than 20 mg for more than 2 weeks), immunosuppressants, biological agents (such as anti TNF-alpha monoclonal antibodies, etc.).
• Subjects with HIV.
• Subjects under treatment with metformin.
• Subjects treated with Sertraline.
• Subjects treated with statins.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bacmune (MV130); Subject included in the active group will receive Bacmune. The dose consists on 2 spray puff every 12 hours for 45 days.	Biological: BACMUNE (MV130); BACMUNE (MV130) is a bacterial preparation that contains a mixture of Gram + and Gram - inactivated bacteria at the concentration of 300 FTU / mL (approx. 10^9 bacteria / mL)
Placebo Comparator: Placebo; Subject included in the placebo group will receive placebo. The dose consists on 2 spray puff every 12 hours for 45 days.	Other: Placebo; Placebo is a solution on sodium chloride at 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of subjects with COVID-19	Incidence of subjects with COVID-19, defined by the presence of: Fever; Any of the respiratory signs and/or symptoms: cough, dyspnea, respiratory failure, runny nose/nasal obstruction.; Positive test for SARS-COV-2 (PCR o serology)	60 days
Severity of COVID-19	Incidence of severe COVID-19, defined by CURB > 2 and/or death	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion to SARS-CoV-2	Rate of subjects with seroconversion to SARS-CoV-2 (negative serology at the beginning of the study and positive at the end of the study	60 days
Subjects with symptoms	Rate of subjects with any symptoms, whether confirmed, probable or suspected, according to the WHO definition	60 days
Hospital admission due to COVID-19	The effect of the treatment on the severity of the disease will be measured based on the rate of subjects requiring hospital admission for COVID-19	60 days
Admission to an intensive care unit due to COVID-19	The effect of the treatment on the severity of the disease will be measured based on the rate of subjects who require admission to an intensive care unit for COVID-19 • Time from confirmation of SARS-CoV-2 infection to the appearance of symptoms.	60 days
Elapsed time until hospitalization	Elapsed time until the first symptoms of COVID-19 appears to hospitalization due to COVID-19.	60 days
Elapsed time until admission into an care unit for COVID-19	Elapsed time until the first symptoms of COVID-19 appears to admission into an intensive care unit pro COVID-19.	60 days
Elapsed time until death not related to COVID-19	Elapsed time until the first symptoms of COVID-19 appears to death from any cause not related to COVID-19.	60 days

Collaborators and Investigators

• Sponsor: Inmunotek S.L.
• Investigators: Principal Investigator: Rosaura Esperanza Benitez Pérez; Principal Investigator: Felipe Monrroy López; Principal Investigator: Blanca Nohemí Zamora Mendoza

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: June 26, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: MV130-SLG-037

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