Back to resultsEvaluation of the Probiotic Lactobacillus Coryniformis K8 on COVID-19 Prevention in Healthcare Workers
Primary Purpose
Covid-19
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Probiotic
Control
Sponsored by
About this trial
This is an interventional prevention trial for Covid-19 focused on measuring Covid-19, Prevention, Healthcare workers
Eligibility Criteria
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.
Sites / Locations
- Raquel Rodriguez BlanqueRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotic
Control
Arm Description
Experimental group who will receive one capsule of Lactobacillus K8 per day (3x10^9 cfu/day).
Control group who will receive a daily placebo capsule consisting of maltodextrin
Outcomes
Primary Outcome Measures
Incidence of SARS CoV-2 infection in healthcare workers
The incidence of SARS CoV-2 infection will be confirmed by PCR or antigen test
Secondary Outcome Measures
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
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
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
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
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
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
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
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
Medical treatment
Use of drugs (dosis and duration of the treatment) for Covid-19 treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04366180
Brief Title
Evaluation of the Probiotic Lactobacillus Coryniformis K8 on COVID-19 Prevention in Healthcare Workers
Official Title
Multicentric Study to Assess the Effect of Consumption of Lactobacillus Coryniformis K8 on Healthcare Personnel Exposed to COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 24, 2020 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosearch S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19
Keywords
Covid-19, Prevention, Healthcare workers
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
314 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Experimental
Arm Description
Experimental group who will receive one capsule of Lactobacillus K8 per day (3x10^9 cfu/day).
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control group who will receive a daily placebo capsule consisting of maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
The probiotic group will received one capsule with Lactobacillus K8 per day (3x10^9 cfu/day) during 2 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
The control group will received one placebo capsule per day during 2 months
Primary Outcome Measure Information:
Title
Incidence of SARS CoV-2 infection in healthcare workers
Description
The incidence of SARS CoV-2 infection will be confirmed by PCR or antigen test
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Incidence of hospital admissions caused by SARS-CoV-2 infection
Description
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
Time Frame
8 weeks
Title
Incidence of ICU admissions caused by SARS-CoV-2 infection
Description
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
Time Frame
8 weeks
Title
Incidence of pneumonia caused by SARS-CoV-2 infection
Description
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
Time Frame
8 weeks
Title
Incidence of oxygen support requirement caused by SARS-CoV-2 infection
Description
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
Time Frame
8 weeks
Title
Incidence of gastrointestinal symptoms caused by SARS-CoV-2 infection
Description
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
Time Frame
8 weeks
Title
Days with body's temperature > 37.5 ºC
Description
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
Time Frame
8 weeks
Title
Days with cough
Description
In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), number of days with cough during the course of the disease
Time Frame
8 weeks
Title
Days with fatigue
Description
In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), number of days with fatigue during the course of the disease
Time Frame
8 weeks
Title
Medical treatment
Description
Use of drugs (dosis and duration of the treatment) for Covid-19 treatment
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raquel Rodriguez Blanque
Phone
+34 958 023 000
Email
raquel.rodriguez.blanque.sspa@juntadeandalucia.es
Facility Information:
Facility Name
Raquel Rodriguez Blanque
City
Granada
ZIP/Postal Code
18016
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel Rodriguez Blanque
Phone
+34 958 023 000
Email
raquel.rodriguez.blanque.sspa@juntadeandalucia.es
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Probiotic Lactobacillus Coryniformis K8 on COVID-19 Prevention in Healthcare Workers
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