Evaluation of the Probiotic Lactobacillus Coryniformis K8 on COVID-19 Prevention in Healthcare Workers

Study Overview
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Brief Summary
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The aim of the present study is to evaluate the effects of Lactobacillus coryniformis K8 consumption on the incidence and severity of Covid-19 in health workers exposed to the virus. This is a preventive study

Official Title
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Multicentric Study to Assess the Effect of Consumption of Lactobacillus Coryniformis K8 on Healthcare Personnel Exposed to COVID-19

Conditions
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Covid-19

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persons over 20 years of age. Active healthcare personnel, who attend patients with COVID-19 disease, including all professional categories, medicine, nursing and warders. Ability to complete surveys. Signature of informed consent Exclusion Criteria: Person with positive test of COVID-19 confirmed by PCR test or serology Person with concomitant pathology HIV, transplant, active oncology or other type of active immunosuppression Pregnant women or women with intention to become pregnant in the next 2 months.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>Experimental group who will receive one capsule of Lactobacillus K8 per day (3x10^9 cfu/day). | Dietary Supplement: Probiotic<br>* The probiotic group will received one capsule with Lactobacillus K8 per day (3x10^9 cfu/day) during 2 months<br>|
| Placebo Comparator: Control<br>Control group who will receive a daily placebo capsule consisting of maltodextrin | Dietary Supplement: Control<br>* The control group will received one placebo capsule per day during 2 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of SARS CoV-2 infection in healthcare workers | The incidence of SARS CoV-2 infection will be confirmed by PCR or antigen test | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hospital admissions caused by SARS-CoV-2 infection | In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will required hospital admission because of Covid-19 | 8 weeks | 
| Incidence of ICU admissions caused by SARS-CoV-2 infection | In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will required ICU admission because of Covid-19 | 8 weeks | 
| Incidence of pneumonia caused by SARS-CoV-2 infection | In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will develop pneumonia because of Covid-19 | 8 weeks | 
| Incidence of oxygen support requirement caused by SARS-CoV-2 infection | In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will require oxygen support because of Covid-19 | 8 weeks | 
| Incidence of gastrointestinal symptoms caused by SARS-CoV-2 infection | In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will develop gastrointestinal symptoms because of Covid-19 | 8 weeks | 
| Days with body's temperature > 37.5 ºC | In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), number of days with body's temperature > 37.5 ºC during the course of the disease | 8 weeks | 
| Days with cough | In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), number of days with cough during the course of the disease | 8 weeks | 
| Days with fatigue | In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), number of days with fatigue during the course of the disease | 8 weeks | 
| Medical treatment | Use of drugs (dosis and duration of the treatment) for Covid-19 treatment | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid-19, Prevention, Healthcare workers