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Clinical Trials/NCT04390477
NCT04390477
Completed
Not Applicable

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

Bioithas SL2 sites in 1 country41 target enrollmentMay 4, 2020
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ConditionsCOVID-19Coronavirus Infection

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Bioithas SL
Enrollment
41
Locations
2
Primary Endpoint
Cases with discharge to ICU.
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 4, 2020
End Date
April 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Cases with discharge to ICU.

Time Frame: 30-days

Percentage of patients with discharge to ICU.

Patients with resolution of digestive symptoms

Time Frame: 30 days

Percentage of patients with improvement between the initial and final visits

Secondary Outcomes

  • Patients with resolution of non-digestive symptoms(30 days)
  • Patients with negative PCR and/or Antigen test result for SARS-CoV-2 infection.(10-15 days)
  • New cases of SARS-Cov-2 infection among healthcare personnel caring for the patients.(30-days)
  • Mortality.(30-days)
  • Treatment safety assessed by number of adverse events.(30-days)
  • Patients with home discharge.(30-days)

Study Sites (2)

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