SARS CoV-2 Infection, Elderly
Conditions
Keywords
Probiotics, COVID19
Brief summary
The objective of this trial is to evaluate the effect of the consumption of a probiotic strain on the incidence and severity of COVID-19 in elderly population living in a nursing home. In addition, it will be evaluated if the probiotic strain have some effect on the immune response generated by the Covid-19 vaccine inthis population.
Detailed description
The working hypothesis is that the administration of a Lactobacillus strain improves the immune response in the elderly population, improving the immune response to a possible COVID-19 infection. The strain would act as an adjuvant that contributes to developing an effective response against the virus, and therefore there are fewer infectious symptoms due to this virus or, if it appears, it occurs in a milder way among the subjects who take the probiotic strain. Also,the investigators hypothesizes that the administration of the Lactobacillus may improve the immune response generated by the Covid-19 vaccine in this elderly population.
Interventions
DIETARY_SUPPLEMENTPlacebo
Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits
DIETARY_SUPPLEMENTLactobacillus
Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits
Sponsors
Biosearch S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Person over 60 years of age. 2. Intern in residence for the elderly. 3. Sign informed consent.
Exclusion criteria
1. Person who at some previous time has tested positive for detection of COVID-19 by PCR or serology. 2. Person who at the time of starting the intervention presents symptoms compatible with COVID-19. 3. Person with concomitant disease type HIV, transplant, active cancer or other type of active immunosuppression.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of SARS CoV-2 infection. | 3 months | Incidence of SARS CoV-2 infection confirmed by PCR or antigen test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ICU admissions caused by SARS-CoV-2 infection | 3 months | Incidence of ICU admissions caused by infection caused by SARS-CoV-2 confirmed by PCR or antigen test |
| Incidence of pneumonia caused by SARS-CoV-2 infection . | 3 months | Incidence of pneumonia caused by infection caused by SARS-CoV-2 confirmed by PCR or antigen test |
| Incidence of need for oxygen support due to SARS-CoV-2 infection.. | 3 months | Incidence of need for oxygen support due to SARS-CoV-2 infection confirmed by PCR or antigen test. |
| Incidence of gastrointestinal symptoms due to SARS-CoV-2 infection. | 3 months | Incidence of gastrointestinal symptoms due to SARS-CoV-2 infection confirmed by PCR or antigen test. |
| Days with body temperature> 37.5ºC. | 3 months | In case of SARS-CoV-2 infection confirmed by PCR or antigen test, Days with body temperature\> 37.5ºC |
| Incidence of hospital admissions caused by SARS-CoV-2 infection . | 3 months | Incidence of hospital admissions caused by infection caused by SARS-CoV-2 confirmed by PCR or antigen test |
| Days of persistent feeling of fatigue. | 3 months | In case of SARS-CoV-2 infection confirmed by PCR or antigen test, Days of persistent feeling of fatigue. |
| Use of pharmacological treatments. | 3 months | In case of SARS-CoV-2 infection confirmed by PCR or antigen test, use of pharmacological treatments |
| Serum levels of IgG antibody against SARS-CoV-2 | 6-weeks from second dose of the vaccine | In case volunteers was vaccinated against SARS-CoV-2, the serum levels of IgG antibody against SARS-CoV-2 will be measured, at 6 weeks from the second dose of the vaccine |
| Serum levels of IgA antibody against SARS-CoV-2 | 6-weeks from second dose of the vaccine | In case volunteers was vaccinated against SARS-CoV-2, the serum levels of IgA antibody against SARS-CoV-2 will be measured, at 6 weeks from the second dose of the vaccine |
| Days of persistent cough. | 3 months | In case of SARS-CoV-2 infection confirmed by PCR or antigen test, Days with persistent cough |
Countries
Spain
Outcome results
None listed