Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to SARS-CoV-2 Infection in Healthcare Personnel

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: November 2021

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

Interventions

  • 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)
  • Other: Placebo
    • Placebo is a solution on sodium chloride at 0.9%

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of subjects with COVID-19
    • Time Frame: 60 days
    • 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)
  • Severity of COVID-19
    • Time Frame: 60 days
    • Incidence of severe COVID-19, defined by CURB > 2 and/or death

Secondary Measures

  • Seroconversion to SARS-CoV-2
    • Time Frame: 60 days
    • 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
  • Subjects with symptoms
    • Time Frame: 60 days
    • Rate of subjects with any symptoms, whether confirmed, probable or suspected, according to the WHO definition
  • Hospital admission due to COVID-19
    • Time Frame: 60 days
    • 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
  • Admission to an intensive care unit due to COVID-19
    • Time Frame: 60 days
    • 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.
  • Elapsed time until hospitalization
    • Time Frame: 60 days
    • Elapsed time until the first symptoms of COVID-19 appears to hospitalization due to COVID-19.
  • Elapsed time until admission into an care unit for COVID-19
    • Time Frame: 60 days
    • Elapsed time until the first symptoms of COVID-19 appears to admission into an intensive care unit pro COVID-19.
  • Elapsed time until death not related to COVID-19
    • Time Frame: 60 days
    • Elapsed time until the first symptoms of COVID-19 appears to death from any cause not related to COVID-19.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Inmunotek S.L.
  • Collaborator
    • BioClever 2005 S.L.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Rosaura Esperanza Benitez Pérez, Principal Investigator,
    • Felipe Monrroy López, Principal Investigator,
    • Blanca Nohemí Zamora Mendoza, Principal Investigator,
  • Overall Contact(s)
    • Miguel Casanovas, +34916510010, mcasanovas@inmunotek.com

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