Clinical Trial to Evaluate the Efficacy of Food Supplement Manremyc® Against SARS- COV-2 Infection (COVID-19) in Healthcare Workers

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of Manremyc® food supplement for reduce the incidence of SARS-CoV-2 infection in a high risk population, as healthcare workers.

Official Title
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Double-blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of the Manremyc® Food Supplement to Prevent SARS-CoV-2 Infection

Conditions
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COVID19

Intervention / Treatment
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* Dietary Supplement: Manremyc
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign the Informed Consent before initiating the selection procedures. Health system workers working in contact with subjects potentially infected with SARS-CoV-2. People ≥ 18 years. Availability to meet the requirements of the protocol. Negative Rapid Serological Test of SARS-CoV-2 Exclusion Criteria: Previous SARS-CoV-2 infection Pregnancy or breastfeeding. Suspected of active viral or bacterial infection. Symptoms compatible with COVID-19, despite a negative PCR test. Vaccination in the last 4 weeks or planned vaccination during the study period, regardless of the type of vaccine. Participation in a research that requires experimental intervention (does not include observational studies) in the previous month before signing the Consent or during the study. Severely immunocompromised people. This exclusion category includes: Subjects with human immunodeficiency virus (HIV-1). Neutropenic subjects with less than 500 neutrophils / mm3. Subjects with solid organ transplantation. Subjects with bone marrow transplantation. Subjects undergoing chemotherapy. Subjects with primary immunodeficiency. Severe lymphopenia with less than 400 lymphocytes / mm3. Treatment with any anti-cytokine therapy. Oral treatment with steroids, defined as daily doses of 10 mg prednisone or equivalent for more than 3 months. Malignancy, or active solid or non-solid lymphoma from the previous two years. BCG vaccination in the last 10 years. Treatment with Manremyc® for the last 6 months. Chloroquine or hydroxychloroquine administration in the last two weeks. Direct involvement in the design or execution of the MANRECOVID19 clinical trial. Retirement, transfer, long-term leave (> 1 month) due to scheduled surgery or any other event that makes it impossible to work in person at your health center during the months following the recruitment to the study. Employee at the health center <22 hours per week. Do not have a smartphone. Detection by the investigator of lack of knowledge or willingness to participate and comply with all requirements of the protocol. Any other findings that, at the discretion of the investigator, may compromise compliance with the protocol or that may influence significantly the interpretation or the results of the effects of probiotic.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manremyc<br>Participants will receive daily oral administration of a capsule of Manremyc for 14 days in the morning with breakfast | Dietary Supplement: Manremyc<br>* Manremyc is composed by 10E5 heat-inactivated Mycobacterium s. manresensis bacilli<br>|
| Placebo Comparator: Placebo<br>Participants will receive daily oral administration of a capsule of Placebo for 14 days in the morning with breakfast | Dietary Supplement: Placebo<br>* Same excipients than active arm without bacilli.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documented cumulative incidence of SARS-CoV-2 infection | % of positive serology at the end of the study or positive PCR test in the course of routine clinical practice | up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documented sick leave for SARS-CoV-2 | Number of days Documented as sick leave for SARS-CoV-2 | up to 4 months (cumulative) | 
| days off work due to the quarantine | Number of days off work due to the quarantine imposed as a consequence to have acute respiratory symptoms, fever or infection documented by SARS-CoV-2 | up to 4 months | 
| Quarantine imposed by close contact outside the center with SARS-CoV-2 positive | Number of days in quarantine imposed by close contact outside the center with SARS-CoV-2 positive | up to 4 months | 
| Fever | Number of days of self-reported fever (≥38 ºC) | Up to 4 months | 
| Cumulative incidence of self-reported acute respiratory symptoms | Cumulative incidence of self-reported acute respiratory symptoms | up to 4 months | 
| Number of days of self-reported acute respiratory symptoms | Number of days of self-reported acute respiratory symptoms | up to 4 months | 
| Incidence of pneumonia | Number of participants with pneumonia confirmed by X-ray | up to 4 months | 
| Cumulative incidence of death from documented SARS-CoV-2 infection | Cumulative incidence of death from documented SARS-CoV-2 infection | Up to 4 months | 
| Incidence of admission to ICU | Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection | Up to 4 months | 
| Days in IUC | Number of days admitted to the ICU for documented SARS-CoV-2 infection | Up to 4 months | 
| Incidence of mechanical ventilation | Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection | Up to 4 months | 
| Incidence of hospital admissions | Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection | Up to 4 months | 
| Days of hospitalization | Number of days of hospitalization for documented SARS-CoV-2 infection | Up to 4 months | 
| Levels of IgG | Levels of IgG | Up to 4 months | 
| Levels of IgM | Levels of IgM | Up to 4 months | 
| Levels of SARS-CoV-2 antibodies at the end of the study period | Levels of SARS-CoV-2 antibodies at the end of the study period | Up to 4 months |