Clinical Trial to Evaluate the Efficacy of Food Supplement Manremyc® Against SARS- COV-2 Infection (COVID-19) in Healthcare Workers
NCT ID: NCT04452773
Last Updated: 2020-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
315 participants
INTERVENTIONAL
2020-07-14
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Manremyc
Participants will receive daily oral administration of a capsule of Manremyc for 14 days in the morning with breakfast
Manremyc
Manremyc is composed by 10E5 heat-inactivated Mycobacterium s. manresensis bacilli
Placebo
Participants will receive daily oral administration of a capsule of Placebo for 14 days in the morning with breakfast
Placebo
Same excipients than active arm without bacilli.
Interventions
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Manremyc
Manremyc is composed by 10E5 heat-inactivated Mycobacterium s. manresensis bacilli
Placebo
Same excipients than active arm without bacilli.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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Reig Jofre Group
INDUSTRY
Responsible Party
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Locations
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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, Spain
Hospital Universitari Germans Trias i Pujol UBP Riscos Laborals, Badalona,
Badalona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Magda Alemany, Dr.
Role: primary
Eli Sánchez
Role: backup
Other Identifiers
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MANRECOVID19
Identifier Type: -
Identifier Source: org_study_id
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