Back to resultsStudy to Evaluate the Effect of a Probiotic in COVID-19
Primary Purpose
COVID-19, Coronavirus Infection
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Probiotic
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Probiotic
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitario del Vinalopó
- Hospital Universitario de Torrevieja
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Probiotic
Control
Arm Description
1 pill od containing 1x10E9 cfu of the probiotic
No treatment
Outcomes
Primary Outcome Measures
Cases with discharge to ICU.
Percentage of patients with discharge to ICU.
Patients with resolution of digestive symptoms
Percentage of patients with improvement between the initial and final visits
Secondary Outcome Measures
Patients with home discharge.
Percentage of patients with home discharge.
Mortality.
Percentage of deaths.
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.
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.
Patients with negative PCR and/or Antigen test result for SARS-CoV-2 infection.
Percentage of patients with negative test for SARS-CoV-2.
Patients with resolution of non-digestive symptoms
Percentage of patients with improvement between the initial and final visits
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04390477
Brief Title
Study to Evaluate the Effect of a Probiotic in COVID-19
Official Title
The Intestinal Microbiota as a Therapeutic Target in Hospitalized Patients With COVID-19 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 4, 2020 (Actual)
Primary Completion Date
March 21, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioithas SL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Coronavirus Infection
Keywords
Probiotic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Random numbers table. One branch placebo and other one no intervention
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Experimental
Arm Description
1 pill od containing 1x10E9 cfu of the probiotic
Arm Title
Control
Arm Type
No Intervention
Arm Description
No treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
Oral daily capsule containing probiotic strains with maltodextrin as excipient, administrated for 30 days.
Primary Outcome Measure Information:
Title
Cases with discharge to ICU.
Description
Percentage of patients with discharge to ICU.
Time Frame
30-days
Title
Patients with resolution of digestive symptoms
Description
Percentage of patients with improvement between the initial and final visits
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Patients with home discharge.
Description
Percentage of patients with home discharge.
Time Frame
30-days
Title
Mortality.
Description
Percentage of deaths.
Time Frame
30-days
Title
Treatment safety assessed by number of adverse events.
Description
Number of adverse events that occur during the treatment period, attributable or not to the intervention product.
Time Frame
30-days
Title
New cases of SARS-Cov-2 infection among healthcare personnel caring for the patients.
Description
Number of new cases of positive SARS-Cov-2 infection by PCR analysis.
Time Frame
30-days
Title
Patients with negative PCR and/or Antigen test result for SARS-CoV-2 infection.
Description
Percentage of patients with negative test for SARS-CoV-2.
Time Frame
10-15 days
Title
Patients with resolution of non-digestive symptoms
Description
Percentage of patients with improvement between the initial and final visits
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicente Navarro
Organizational Affiliation
Hospital universitario del Vinalopo, Elche, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario del Vinalopó
City
Elche
State/Province
Alicante
ZIP/Postal Code
03293
Country
Spain
Facility Name
Hospital Universitario de Torrevieja
City
Torrevieja
State/Province
Alicante
ZIP/Postal Code
03198
Country
Spain
12. IPD Sharing Statement
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Study to Evaluate the Effect of a Probiotic in COVID-19
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