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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 : Recruiting
First Posted : June 30, 2020
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Reig Jofre Group

Tracking Information
First Submitted Date  ICMJE June 25, 2020
First Posted Date  ICMJE June 30, 2020
Last Update Posted Date July 15, 2020
Actual Study Start Date  ICMJE July 14, 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 29, 2020)
  • 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
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Evaluate the Efficacy of Food Supplement Manremyc® Against SARS- COV-2 Infection (COVID-19) in Healthcare Workers
Official Title  ICMJE Double-blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of the Manremyc® Food Supplement to Prevent SARS-CoV-2 Infection
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE COVID19
Intervention  ICMJE
  • Dietary Supplement: Manremyc
    Manremyc is composed by 10E5 heat-inactivated Mycobacterium s. manresensis bacilli
  • Dietary Supplement: Placebo
    Same excipients than active arm without bacilli.
Study Arms  ICMJE
  • Experimental: Manremyc
    Participants will receive daily oral administration of a capsule of Manremyc for 14 days in the morning with breakfast
    Intervention: Dietary Supplement: Manremyc
  • Placebo Comparator: Placebo
    Participants will receive daily oral administration of a capsule of Placebo for 14 days in the morning with breakfast
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 3, 2020)
315
Original Estimated Enrollment  ICMJE
 (submitted: June 29, 2020)
325
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pere Joan Cardona, MD, PhD +34934978681 pjcardona@igtp.cat
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04452773
Other Study ID Numbers  ICMJE MANRECOVID19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Reig Jofre Group
Study Sponsor  ICMJE Reig Jofre Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Reig Jofre Group
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP