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

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

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.

Study Overview

• Status: Unknown
• Conditions: COVID19
• Intervention / Treatment: Dietary supplement: Manremyc; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 315
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pere Joan Cardona, MD, PhD; Phone Number: +34934978681; Email: pjcardona@igtp.cat

Study Locations

• Spain
  • Badalona, Spain, 08916
    • Not yet recruiting
    • Hospital Universitari Germans Trias i Pujol UBP Riscos Laborals, Badalona,
    • Contact: Joan Matllo, Dr.; Phone Number: 670282689; Email: jmatlloaguilar@gencat.cat
    • Principal Investigator: Pere Joan Cardona, MD, PhD
    • Sub-Investigator: Joan Matllo, Dr.
  • BArcelona
    • Santa Coloma De Gramenet, BArcelona, Spain, 08921
      • Not yet recruiting
      • EAP Riu Nord
      • Contact: Magda Alemany, Dr.
      • Contact: Eli Sánchez
  • Barcelona
    • Cornellà De Llobregat, Barcelona, Spain, 08940
      • Not yet recruiting
      • CAP Cornellà (La Gavarra)
      • Contact: Mª Betlem Salvador, Dr.; Phone Number: +34 93 857 55 45; Email: bsalvador@ambitcp.catsalut.net
      • Contact: Sofía Berlanga; Phone Number: +34 93 857 55 45; Email: sberlanga.cp.ics@gencat.cat
    • Mataró, Barcelona, Spain, 08303
      • Not yet recruiting
      • CAP Maresme
      • Contact: Pere Torán, Dr.; Phone Number: +34 93 741 60 73; Email: ptoran.bnm.ics@gencat.cat
      • Contact: Noemí Lamonja; Phone Number: +34 93 741 60 73; Email: noemilamonjavicente@gmail.com
    • Sabadell, Barcelona, Spain, 08203
      • Recruiting
      • Cap Sant Fèlix
      • Contact: Concepció Violant, Dr.; Phone Number: 93 693 27 32; Email: cviolanf.mn.ics@gencat.cat
      • Contact: Mª José Argerich, Dr.; Phone Number: 675785198; Email: mjargerich.mn.ics@gencat.cat
      • Principal Investigator: Concepció Violant, Dr.
      • Sub-Investigator: Mª José Argerich, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 4 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
AEs	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	Up to 4 months
SAEs	All thoseAdverse Events that lead to hospitalization of the patient, that endanger his life or cause or may cause death.	Up to 4 moths

Collaborators and Investigators

• Sponsor: Reig Jofre Group

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2020
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): July 15, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: MANRECOVID19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No