Covid-19
Conditions
Keywords
Covid-19, Prevention, Healthcare workers
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
Interventions
DIETARY_SUPPLEMENTProbiotic
The probiotic group will received one capsule with Lactobacillus K8 per day (3x10\^9 cfu/day) during 2 months
DIETARY_SUPPLEMENTControl
The control group will received one placebo capsule per day during 2 months
Sponsors
Biosearch S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of SARS CoV-2 infection in healthcare workers | 8 weeks | The incidence of SARS CoV-2 infection will be confirmed by PCR or antigen test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ICU admissions caused by SARS-CoV-2 infection | 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 |
| Incidence of pneumonia caused by SARS-CoV-2 infection | 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 |
| Incidence of oxygen support requirement caused by SARS-CoV-2 infection | 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 |
| Incidence of gastrointestinal symptoms caused by SARS-CoV-2 infection | 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 |
| Incidence of hospital admissions caused by SARS-CoV-2 infection | 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 |
| Days with cough | 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 |
| Days with fatigue | 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 |
| Medical treatment | 8 weeks | Use of drugs (dosis and duration of the treatment) for Covid-19 treatment |
| Days with body's temperature > 37.5 ºC | 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 |
Countries
Spain
Contacts
Primary ContactRaquel Rodriguez Blanque
Outcome results
None listed