Clinical trial NCT04452773: 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
Overall status: UNKNOWN
Phase: NA
Conditions: COVID19
Lead sponsor: Reig Jofre Group
Sponsor class: INDUSTRY
First posted: 2020-06-30
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Documented cumulative incidence of SARS-CoV-2 infection
timeFrame: up to 4 months
Secondary outcomes:
measure: Documented sick leave for SARS-CoV-2
timeFrame: up to 4 months (cumulative)
measure: days off work due to the quarantine
timeFrame: up to 4 months
measure: Quarantine imposed by close contact outside the center with SARS-CoV-2 positive
timeFrame: up to 4 months
measure: Fever
timeFrame: Up to 4 months
measure: Cumulative incidence of self-reported acute respiratory symptoms
timeFrame: up to 4 months
measure: Number of days of self-reported acute respiratory symptoms
timeFrame: up to 4 months
measure: Incidence of pneumonia
timeFrame: up to 4 months
measure: Cumulative incidence of death from documented SARS-CoV-2 infection
timeFrame: Up to 4 months
measure: Incidence of admission to ICU
timeFrame: Up to 4 months
measure: Days in IUC
timeFrame: Up to 4 months
measure: Incidence of mechanical ventilation
timeFrame: Up to 4 months
measure: Incidence of hospital admissions
timeFrame: Up to 4 months
measure: Days of hospitalization
timeFrame: Up to 4 months
measure: Levels of IgG
timeFrame: Up to 4 months
measure: Levels of IgM
timeFrame: Up to 4 months
measure: Levels of SARS-CoV-2 antibodies at the end of the study period
timeFrame: Up to 4 months
Other outcomes:
measure: AEs
timeFrame: Up to 4 months
measure: SAEs
timeFrame: Up to 4 moths
Locations:
city: Cornellà De Llobregat
country: Spain
facility: CAP Cornellà (La Gavarra)
state: Barcelona
city: Mataró
country: Spain
facility: CAP Maresme
state: Barcelona
city: Sabadell
country: Spain
facility: Cap Sant Fèlix
state: Barcelona
city: Santa Coloma De Gramenet
country: Spain
facility: EAP Riu Nord
state: BArcelona
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol UBP Riscos Laborals, Badalona,
Study officials:
References: