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

COVID19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04452773
• Other study ID #: MANRECOVID19
• Status: Recruiting
• Phase: N/A
• Start date: July 14, 2020
• Est. completion date: December 2021

Study information

• Verified date: July 2020
• Source: Reig Jofre Group
• Contact: Pere Joan Cardona, MD, PhD
• Phone: +34934978681
• Email: pjcardona[@]igtp.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 315
• Est. completion date: December 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID19
• Infection

Intervention

Dietary Supplement:
• Manremyc
Manremyc is composed by 10E5 heat-inactivated Mycobacterium s. manresensis bacilli
• Placebo
Same excipients than active arm without bacilli.

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol UBP Riscos Laborals, Badalona,	Badalona
Spain	CAP Cornellà (La Gavarra)	Cornellà De Llobregat	Barcelona
Spain	CAP Maresme	Mataró	Barcelona
Spain	Cap Sant Fèlix	Sabadell	Barcelona
Spain	EAP Riu Nord	Santa Coloma De Gramenet	BArcelona

Sponsors (1)

Lead Sponsor	Collaborator
Reig Jofre Group

Country where clinical trial is conducted

Spain, 

Outcome

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