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

Covid19 Clinical Trial

— Bacmune  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04452643
• Other study ID #: MV130-SLG-037
• Status: Withdrawn
• Phase: Phase 3
• Start date: October 2020
• Est. completion date: December 2021

Study information

• Verified date: October 2020
• Source: Inmunotek S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Infection

Intervention

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%

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Enfermedades Respiratorias (INER)	Ciudad de México
Mexico	Hospital General de Pachuca	Pachuca de Soto
Mexico	Hospital de Ciudad Valles	San Luis Potosí

Sponsors (1)

Lead Sponsor	Collaborator
Inmunotek S.L.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Severity of COVID-19	Incidence of severe COVID-19, defined by CURB > 2 and/or death	60 days
Secondary	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
Secondary	Subjects with symptoms	Rate of subjects with any symptoms, whether confirmed, probable or suspected, according to the WHO definition	60 days
Secondary	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
Secondary	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
Secondary	Elapsed time until hospitalization	Elapsed time until the first symptoms of COVID-19 appears to hospitalization due to COVID-19.	60 days
Secondary	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
Secondary	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