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

Covid-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04366180
• Other study ID #: P054
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2020
• Est. completion date: October 2020

Study information

• Verified date: April 2020
• Source: Biosearch S.A.
• Contact: Raquel Rodriguez Blanque
• Phone: +34 958 023 000
• Email: raquel.rodriguez.blanque.sspa[@]juntadeandalucia.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 314
• Est. completion date: October 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid-19

Intervention

Dietary Supplement:
• Probiotic
The probiotic group will received one capsule with Lactobacillus K8 per day (3x10^9 cfu/day) during 2 months
• Control
The control group will received one placebo capsule per day during 2 months

Locations

Country	Name	City	State
Spain	Raquel Rodriguez Blanque	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Biosearch S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Medical treatment	Use of drugs (dosis and duration of the treatment) for Covid-19 treatment	8 weeks