Study to Evaluate the Effect of a Probiotic in COVID-19

Study Overview
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Brief Summary
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A prospective case-control pilot study to evaluate the possible effect of a probiotic mixture in the improvement of symptoms, the reduction in the number of days of hospitalization and the increase in the percentage of patients with negative PCR after infection with the coronavirus SARS-CoV-2.

Detailed Description
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In this study, the investigators hypothesize a positive effect of probiotic on the gut microbiome that could led to produce a less severe clinical evolution of the disease.

Official Title
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The Intestinal Microbiota as a Therapeutic Target in Hospitalized Patients With COVID-19 Infection

Conditions
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COVID-19, Coronavirus Infection

Intervention / Treatment
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* Dietary Supplement: Probiotic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a confirmed diagnosis of SARS-Cov.2 infection using the PCR and that require admission to the hospitalization area. Exclusion Criteria: Inability or refusal to sign informed consent. Allergy or intolerance to the intervention product or its components.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>1 pill od containing 1x10E9 cfu of the probiotic | Dietary Supplement: Probiotic<br>* Oral daily capsule containing probiotic strains with maltodextrin as excipient, administrated for 30 days.<br>|
| No Intervention: Control<br>No treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cases with discharge to ICU. | Percentage of patients with discharge to ICU. | 30-days | 
| Patients with resolution of digestive symptoms | Percentage of patients with improvement between the initial and final visits | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients with home discharge. | Percentage of patients with home discharge. | 30-days | 
| Mortality. | Percentage of deaths. | 30-days | 
| Treatment safety assessed by number of adverse events. | Number of adverse events that occur during the treatment period, attributable or not to the intervention product. | 30-days | 
| New cases of SARS-Cov-2 infection among healthcare personnel caring for the patients. | Number of new cases of positive SARS-Cov-2 infection by PCR analysis. | 30-days | 
| Patients with negative PCR and/or Antigen test result for SARS-CoV-2 infection. | Percentage of patients with negative test for SARS-CoV-2. | 10-15 days | 
| Patients with resolution of non-digestive symptoms | Percentage of patients with improvement between the initial and final visits | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotic