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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452643
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : July 2, 2020
Sponsor:
Collaborator:
BioClever 2005 S.L.
Information provided by (Responsible Party):
Inmunotek S.L.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Covid19 Biological: BACMUNE (MV130) Other: Placebo Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind placebo control
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double blind placebo control
Primary Purpose: Prevention
Official Title: 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
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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%




Primary Outcome Measures :
  1. 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)

  2. Severity of COVID-19 [ Time Frame: 60 days ]
    Incidence of severe COVID-19, defined by CURB > 2 and/or death


Secondary Outcome Measures :
  1. 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

  2. Subjects with symptoms [ Time Frame: 60 days ]
    Rate of subjects with any symptoms, whether confirmed, probable or suspected, according to the WHO definition

  3. 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

  4. 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.


  5. Elapsed time until hospitalization [ Time Frame: 60 days ]
    Elapsed time until the first symptoms of COVID-19 appears to hospitalization due to COVID-19.

  6. 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.

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452643


Contacts
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Contact: Miguel Casanovas +34916510010 mcasanovas@inmunotek.com

Locations
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Mexico
Instituto Nacional de Enfermedades Respiratorias (INER)
Ciudad de México, Mexico, Ciudad de México
Contact: Rosaura Esperanza Benitez Pérez, MD    5519529876    drarebp@gmail.com   
Hospital General de Pachuca
Pachuca de Soto, Mexico, 42070
Contact: Felipe Monrroy López, MD       felmon1981@gmail.com   
Hospital de Ciudad Valles
San Luis Potosí, Mexico
Contact: Blanca Zamora Mendoza, MD    +52 444 826 1450    blancazamoramendoza@hotmail.com   
Sponsors and Collaborators
Inmunotek S.L.
BioClever 2005 S.L.
Investigators
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Principal Investigator: Rosaura Esperanza Benitez Pérez
Principal Investigator: Felipe Monrroy López
Principal Investigator: Blanca Nohemí Zamora Mendoza
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Responsible Party: Inmunotek S.L.
ClinicalTrials.gov Identifier: NCT04452643    
Other Study ID Numbers: MV130-SLG-037
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection