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

  • STATUS
    Recruiting
  • participants needed
    315
  • sponsor
    Reig Jofre Group
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Updated on 19 February 2024
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SARS
serologic test
acute respiratory syndrome (sars)

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.

Details
Condition COVID19
Age 18years - 100years
Treatment Placebo, Manremyc
Clinical Study IdentifierNCT04452773
SponsorReig Jofre Group
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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