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

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: NCT04452773
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Reig Jofre Group

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COVID19 Dietary Supplement: Manremyc Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Double-blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of the Manremyc® Food Supplement to Prevent SARS-CoV-2 Infection
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Manremyc
Participants will receive daily oral administration of a capsule of Manremyc for 14 days in the morning with breakfast
Dietary Supplement: Manremyc
Manremyc is composed by 10E5 heat-inactivated Mycobacterium s. manresensis bacilli

Placebo Comparator: Placebo
Participants will receive daily oral administration of a capsule of Placebo for 14 days in the morning with breakfast
Dietary Supplement: Placebo
Same excipients than active arm without bacilli.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  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

  3. 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

  4. Fever [ Time Frame: Up to 4 months ]
    Number of days of self-reported fever (≥38 ºC)

  5. Cumulative incidence of self-reported acute respiratory symptoms [ Time Frame: up to 4 months ]
    Cumulative incidence of self-reported acute respiratory symptoms

  6. Number of days of self-reported acute respiratory symptoms [ Time Frame: up to 4 months ]
    Number of days of self-reported acute respiratory symptoms

  7. Incidence of pneumonia [ Time Frame: up to 4 months ]
    Number of participants with pneumonia confirmed by X-ray

  8. 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

  9. 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

  10. Days in IUC [ Time Frame: Up to 4 months ]
    Number of days admitted to the ICU for documented SARS-CoV-2 infection

  11. Incidence of mechanical ventilation [ Time Frame: Up to 4 months ]
    Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection

  12. Incidence of hospital admissions [ Time Frame: Up to 4 months ]
    Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection

  13. Days of hospitalization [ Time Frame: Up to 4 months ]
    Number of days of hospitalization for documented SARS-CoV-2 infection

  14. Levels of IgG [ Time Frame: Up to 4 months ]
    Levels of IgG

  15. Levels of IgM [ Time Frame: Up to 4 months ]
    Levels of IgM

  16. 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


Other Outcome Measures:
  1. AEs [ Time Frame: Up to 4 months ]
    All adverse events reported by the subjects, both serious and non-serious, will be collected. All events related to a SARS-CoV-2 infection will be exempted from collection, as they will be collected as part of the associated symptoms

  2. SAEs [ Time Frame: Up to 4 moths ]
    All thoseAdverse Events that lead to hospitalization of the patient, that endanger his life or cause or may cause death.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT04452773


Contacts
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Contact: Pere Joan Cardona, MD, PhD +34934978681 pjcardona@igtp.cat

Locations
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Spain
Cap Sant Fèlix
Sabadell, Barcelona, Spain, 08203
Contact: Concepció Violant, Dr.    93 693 27 32    cviolanf.mn.ics@gencat.cat   
Contact: Mª José Argerich, Dr.    675785198    mjargerich.mn.ics@gencat.cat   
Principal Investigator: Concepció Violant, Dr.         
Sub-Investigator: Mª José Argerich, Dr.         
Hospital Universitari Germans Trias i Pujol UBP Riscos Laborals, Badalona,
Badalona, Spain, 08916
Contact: Joan Matllo, Dr.    670282689    jmatlloaguilar@gencat.cat   
Principal Investigator: Pere Joan Cardona, MD, PhD         
Sub-Investigator: Joan Matllo, Dr.         
Sponsors and Collaborators
Reig Jofre Group
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Responsible Party: Reig Jofre Group
ClinicalTrials.gov Identifier: NCT04452773    
Other Study ID Numbers: MANRECOVID19
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 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