Clinical trial NCT04452643: Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to COVID-19 Infection in Healthcare Personnel
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Covid19
Lead sponsor: Inmunotek S.L.
Sponsor class: INDUSTRY
First posted: 2020-06-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind placebo control
Primary purpose: PREVENTION

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.

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

Eligibility 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.

Primary outcomes:
measure: Incidence of subjects with COVID-19
timeFrame: 60 days
measure: Severity of COVID-19
timeFrame: 60 days
Secondary outcomes:
measure: Seroconversion to SARS-CoV-2
timeFrame: 60 days
measure: Subjects with symptoms
timeFrame: 60 days
measure: Hospital admission due to COVID-19
timeFrame: 60 days
measure: Admission to an intensive care unit due to COVID-19
timeFrame: 60 days
measure: Elapsed time until hospitalization
timeFrame: 60 days
measure: Elapsed time until admission into an care unit for COVID-19
timeFrame: 60 days
measure: Elapsed time until death not related to COVID-19
timeFrame: 60 days
Other outcomes:
Locations:
city: Ciudad de México
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias (INER)
city: Pachuca de Soto
country: Mexico
facility: Hospital General de Pachuca
city: San Luis Potosí
country: Mexico
facility: Hospital de Ciudad Valles
Study officials:
name: Rosaura Esperanza Benitez Pérez
role: PRINCIPAL_INVESTIGATOR
name: Felipe Monrroy López
role: PRINCIPAL_INVESTIGATOR
name: Blanca Nohemí Zamora Mendoza
role: PRINCIPAL_INVESTIGATOR
References: