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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2020

Interventions

  • Dietary Supplement: Manremyc
    • Manremyc is composed by 10E5 heat-inactivated Mycobacterium s. manresensis bacilli
  • Dietary Supplement: Placebo
    • Same excipients than active arm without bacilli.

Arms, Groups and Cohorts

  • Experimental: Manremyc
    • Participants will receive daily oral administration of a capsule of Manremyc for 14 days in the morning with breakfast
  • Placebo Comparator: Placebo
    • Participants will receive daily oral administration of a capsule of Placebo for 14 days in the morning with breakfast

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

1. Sign the Informed Consent before initiating the selection procedures.

2. Health system workers working in contact with subjects potentially infected with SARS-CoV-2.

3. People ≥ 18 years.

4. Availability to meet the requirements of the protocol.

5. Negative Rapid Serological Test of SARS-CoV-2

Exclusion Criteria

1. Previous SARS-CoV-2 infection

2. Pregnancy or breastfeeding.

3. Suspected of active viral or bacterial infection.

4. Symptoms compatible with COVID-19, despite a negative PCR test.

5. Vaccination in the last 4 weeks or planned vaccination during the study period, regardless of the type of vaccine.

6. 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.

7. Severely immunocompromised people. This exclusion category includes:

1. Subjects with human immunodeficiency virus (HIV-1).

2. Neutropenic subjects with less than 500 neutrophils / mm3.

3. Subjects with solid organ transplantation.

4. Subjects with bone marrow transplantation.

5. Subjects undergoing chemotherapy.

6. Subjects with primary immunodeficiency.

7. Severe lymphopenia with less than 400 lymphocytes / mm3.

8. Treatment with any anti-cytokine therapy.

9. Oral treatment with steroids, defined as daily doses of 10 mg prednisone or equivalent for more than 3 months.

8. Malignancy, or active solid or non-solid lymphoma from the previous two years.

9. BCG vaccination in the last 10 years.

10. Treatment with Manremyc® for the last 6 months.

11. Chloroquine or hydroxychloroquine administration in the last two weeks.

12. Direct involvement in the design or execution of the MANRECOVID19 clinical trial.

13. 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.

14. Employee at the health center <22 hours per week.

15. Do not have a smartphone.

16. Detection by the investigator of lack of knowledge or willingness to participate and comply with all requirements of the protocol.

17. 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Reig Jofre Group
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Pere Joan Cardona, MD, PhD, +34934978681, pjcardona@igtp.cat

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