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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
315
CAP Cornellà (La Gavarra)
Cornellà de Llobregat, Barcelona, Spain
NOT_YET_RECRUITINGCAP Maresme
Mataró, Barcelona, Spain
NOT_YET_RECRUITINGCap Sant Fèlix
Sabadell, Barcelona, Spain
RECRUITINGDocumented 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
Time frame: up to 4 months
Documented sick leave for SARS-CoV-2
Number of days Documented as sick leave for SARS-CoV-2
Time frame: 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
Time frame: 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
Time frame: up to 4 months
Fever
Number of days of self-reported fever (≥38 ºC)
Time frame: Up to 4 months
Cumulative incidence of self-reported acute respiratory symptoms
Cumulative incidence of self-reported acute respiratory symptoms
Time frame: up to 4 months
Number of days of self-reported acute respiratory symptoms
Number of days of self-reported acute respiratory symptoms
Time frame: up to 4 months
Incidence of pneumonia
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EAP Riu Nord
Santa Coloma de Gramenet, BArcelona, Spain
NOT_YET_RECRUITINGHospital Universitari Germans Trias i Pujol UBP Riscos Laborals, Badalona,
Badalona, Spain
NOT_YET_RECRUITINGNumber of participants with pneumonia confirmed by X-ray
Time frame: up to 4 months
Cumulative incidence of death from documented SARS-CoV-2 infection
Cumulative incidence of death from documented SARS-CoV-2 infection
Time frame: Up to 4 months
Incidence of admission to ICU
Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection
Time frame: Up to 4 months
Days in IUC
Number of days admitted to the ICU for documented SARS-CoV-2 infection
Time frame: Up to 4 months
Incidence of mechanical ventilation
Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection
Time frame: Up to 4 months
Incidence of hospital admissions
Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection
Time frame: Up to 4 months
Days of hospitalization
Number of days of hospitalization for documented SARS-CoV-2 infection
Time frame: Up to 4 months
Levels of IgG
Levels of IgG
Time frame: Up to 4 months
Levels of IgM
Levels of IgM
Time frame: 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
Time frame: Up to 4 months