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Trial record 1 of 1 for:    NCT04366180
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Evaluation of the Probiotic Lactobacillus Coryniformis K8 on COVID-19 Prevention in Healthcare Workers

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ClinicalTrials.gov Identifier: NCT04366180
Recruitment Status : Recruiting
First Posted : April 28, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Biosearch S.A.

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

Condition or disease Intervention/treatment Phase
Covid-19 Dietary Supplement: Probiotic Dietary Supplement: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multicentric Study to Assess the Effect of Consumption of Lactobacillus Coryniformis K8 on Healthcare Personnel Exposed to COVID-19
Actual Study Start Date : April 24, 2020
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Probiotic
Experimental group who will receive one capsule of Lactobacillus K8 per day (3x10^9 cfu/day).
Dietary Supplement: Probiotic
The probiotic group will received one capsule with Lactobacillus K8 per day (3x10^9 cfu/day) during 2 months

Placebo Comparator: Control
Control group who will receive a daily placebo capsule consisting of maltodextrin
Dietary Supplement: Control
The control group will received one placebo capsule per day during 2 months




Primary Outcome Measures :
  1. Incidence of SARS CoV-2 infection in healthcare workers [ Time Frame: 8 weeks ]
    The incidence of SARS CoV-2 infection will be confirmed by PCR or antigen test


Secondary Outcome Measures :
  1. Incidence of hospital admissions caused by SARS-CoV-2 infection [ Time Frame: 8 weeks ]
    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

  2. Incidence of ICU admissions caused by SARS-CoV-2 infection [ Time Frame: 8 weeks ]
    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

  3. Incidence of pneumonia caused by SARS-CoV-2 infection [ Time Frame: 8 weeks ]
    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

  4. Incidence of oxygen support requirement caused by SARS-CoV-2 infection [ Time Frame: 8 weeks ]
    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

  5. Incidence of gastrointestinal symptoms caused by SARS-CoV-2 infection [ Time Frame: 8 weeks ]
    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

  6. Days with body's temperature > 37.5 ºC [ Time Frame: 8 weeks ]
    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

  7. Days with cough [ Time Frame: 8 weeks ]
    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. Days with fatigue [ Time Frame: 8 weeks ]
    In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), number of days with fatigue during the course of the disease

  9. Medical treatment [ Time Frame: 8 weeks ]
    Use of drugs (dosis and duration of the treatment) for Covid-19 treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Persons over 20 years of age.
  2. Active healthcare personnel, who attend patients with COVID-19 disease, including all professional categories, medicine, nursing and warders.
  3. Ability to complete surveys.
  4. Signature of informed consent

Exclusion Criteria:

  1. Person with positive test of COVID-19 confirmed by PCR test or serology
  2. Person with concomitant pathology HIV, transplant, active oncology or other type of active immunosuppression
  3. Pregnant women or women with intention to become pregnant in the next 2 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04366180


Contacts
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Contact: Raquel Rodriguez Blanque +34 958 023 000 raquel.rodriguez.blanque.sspa@juntadeandalucia.es

Locations
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Spain
Raquel Rodriguez Blanque Recruiting
Granada, Spain, 18016
Contact: Raquel Rodriguez Blanque    +34 958 023 000    raquel.rodriguez.blanque.sspa@juntadeandalucia.es   
Sponsors and Collaborators
Biosearch S.A.
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Responsible Party: Biosearch S.A.
ClinicalTrials.gov Identifier: NCT04366180    
Other Study ID Numbers: P054
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biosearch S.A.:
Covid-19
Prevention
Healthcare workers