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

Primary Purpose

COVID19

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Manremyc

Placebo

About this trial

This is an interventional prevention trial for COVID19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:
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.
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.

Sites / Locations

CAP Cornellà (La Gavarra)
CAP Maresme
Cap Sant FèlixRecruiting
EAP Riu Nord
Hospital Universitari Germans Trias i Pujol UBP Riscos Laborals, Badalona,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Manremyc

Placebo

Arm Description

Participants will receive daily oral administration of a capsule of Manremyc for 14 days in the morning with breakfast

Participants will receive daily oral administration of a capsule of Placebo for 14 days in the morning with breakfast

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Documented sick leave for SARS-CoV-2

Number of days Documented as sick leave for SARS-CoV-2

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

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

Fever

Number of days of self-reported fever (≥38 ºC)

Cumulative incidence of self-reported acute respiratory symptoms

Number of days of self-reported acute respiratory symptoms

Incidence of pneumonia

Number of participants with pneumonia confirmed by X-ray

Cumulative incidence of death from documented SARS-CoV-2 infection

Incidence of admission to ICU

Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection

Days in IUC

Number of days admitted to the ICU for documented SARS-CoV-2 infection

Incidence of mechanical ventilation

Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection

Incidence of hospital admissions

Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection

Days of hospitalization

Number of days of hospitalization for documented SARS-CoV-2 infection

Levels of IgG

Levels of IgM

Levels of SARS-CoV-2 antibodies at the end of the study period

Full Information

NCT ID

NCT04452773

First Posted

June 25, 2020

Last Updated

July 14, 2020

Sponsor

Reig Jofre Group

1. Study Identification

Unique Protocol Identification Number

NCT04452773

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 14, 2020 (Actual)

Primary Completion Date

September 2020 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Reig Jofre Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID19

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

315 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Manremyc

Arm Type

Experimental

Arm Description

Participants will receive daily oral administration of a capsule of Manremyc for 14 days in the morning with breakfast

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants will receive daily oral administration of a capsule of Placebo for 14 days in the morning with breakfast

Intervention Type

Dietary Supplement

Intervention Name(s)

Manremyc

Intervention Description

Manremyc is composed by 10E5 heat-inactivated Mycobacterium s. manresensis bacilli

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Same excipients than active arm without bacilli.

Primary Outcome Measure Information:

Title

Documented cumulative incidence of SARS-CoV-2 infection

Description

% of positive serology at the end of the study or positive PCR test in the course of routine clinical practice

Time Frame

up to 4 months

Secondary Outcome Measure Information:

Title

Documented sick leave for SARS-CoV-2

Description

Number of days Documented as sick leave for SARS-CoV-2

Time Frame

up to 4 months (cumulative)

Title

days off work due to the quarantine

Description

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

Time Frame

up to 4 months

Title

Quarantine imposed by close contact outside the center with SARS-CoV-2 positive

Description

Number of days in quarantine imposed by close contact outside the center with SARS-CoV-2 positive

Time Frame

up to 4 months

Title

Fever

Description

Number of days of self-reported fever (≥38 ºC)

Time Frame

Up to 4 months

Title

Cumulative incidence of self-reported acute respiratory symptoms

Description

Cumulative incidence of self-reported acute respiratory symptoms

Time Frame

up to 4 months

Title

Number of days of self-reported acute respiratory symptoms

Description

Number of days of self-reported acute respiratory symptoms

Time Frame

up to 4 months

Title

Incidence of pneumonia

Description

Number of participants with pneumonia confirmed by X-ray

Time Frame

up to 4 months

Title

Cumulative incidence of death from documented SARS-CoV-2 infection

Description

Cumulative incidence of death from documented SARS-CoV-2 infection

Time Frame

Up to 4 months

Title

Incidence of admission to ICU

Description

Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection

Time Frame

Up to 4 months

Title

Days in IUC

Description

Number of days admitted to the ICU for documented SARS-CoV-2 infection

Time Frame

Up to 4 months

Title

Incidence of mechanical ventilation

Description

Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection

Time Frame

Up to 4 months

Title

Incidence of hospital admissions

Description

Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection

Time Frame

Up to 4 months

Title

Days of hospitalization

Description

Number of days of hospitalization for documented SARS-CoV-2 infection

Time Frame

Up to 4 months

Title

Levels of IgG

Description

Levels of IgG

Time Frame

Up to 4 months

Title

Levels of IgM

Description

Levels of IgM

Time Frame

Up to 4 months

Title

Levels of SARS-CoV-2 antibodies at the end of the study period

Description

Levels of SARS-CoV-2 antibodies at the end of the study period

Time Frame

Up to 4 months

Other Pre-specified Outcome Measures:

Title

AEs

Description

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

Time Frame

Up to 4 months

Title

SAEs

Description

All thoseAdverse Events that lead to hospitalization of the patient, that endanger his life or cause or may cause death.

Time Frame

Up to 4 moths

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pere Joan Cardona, MD, PhD

Phone

+34934978681

pjcardona@igtp.cat

Facility Information:

Facility Name

CAP Cornellà (La Gavarra)

City

Cornellà De Llobregat

State/Province

Barcelona

ZIP/Postal Code

08940

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mª Betlem Salvador, Dr.

Phone

+34 93 857 55 45

bsalvador@ambitcp.catsalut.net

First Name & Middle Initial & Last Name & Degree

Sofía Berlanga

Phone

+34 93 857 55 45

sberlanga.cp.ics@gencat.cat

Facility Name

CAP Maresme

City

Mataró

State/Province

Barcelona

ZIP/Postal Code

08303

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pere Torán, Dr.

Phone

+34 93 741 60 73

ptoran.bnm.ics@gencat.cat

First Name & Middle Initial & Last Name & Degree

Noemí Lamonja

Phone

+34 93 741 60 73

noemilamonjavicente@gmail.com

Facility Name

Cap Sant Fèlix

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08203

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Concepció Violant, Dr.

Phone

93 693 27 32

cviolanf.mn.ics@gencat.cat

First Name & Middle Initial & Last Name & Degree

Mª José Argerich, Dr.

Phone

675785198

mjargerich.mn.ics@gencat.cat

First Name & Middle Initial & Last Name & Degree

Concepció Violant, Dr.

First Name & Middle Initial & Last Name & Degree

Mª José Argerich, Dr.

Facility Name

EAP Riu Nord

City

Santa Coloma De Gramenet

State/Province

BArcelona

ZIP/Postal Code

08921

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Magda Alemany, Dr.

First Name & Middle Initial & Last Name & Degree

Eli Sánchez

Facility Name

Hospital Universitari Germans Trias i Pujol UBP Riscos Laborals, Badalona,

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joan Matllo, Dr.

Phone

670282689

jmatlloaguilar@gencat.cat

First Name & Middle Initial & Last Name & Degree

Pere Joan Cardona, MD, PhD

First Name & Middle Initial & Last Name & Degree

Joan Matllo, Dr.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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