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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04390477
• Other study ID #: COVID.PROB
• Status: Completed
• Phase: N/A
• Start date: May 4, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: July 2021
• Source: Bioithas SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 30, 2021
• Est. primary completion date: March 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• COVID-19
• Infections

Intervention

Dietary Supplement:
• Probiotic
Oral daily capsule containing probiotic strains with maltodextrin as excipient, administrated for 30 days.

Locations

Country	Name	City	State
Spain	Hospital Universitario del Vinalopó	Elche	Alicante
Spain	Hospital Universitario de Torrevieja	Torrevieja	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Bioithas SL

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cases with discharge to ICU.	Percentage of patients with discharge to ICU.	30-days
Primary	Patients with resolution of digestive symptoms	Percentage of patients with improvement between the initial and final visits	30 days
Secondary	Patients with home discharge.	Percentage of patients with home discharge.	30-days
Secondary	Mortality.	Percentage of deaths.	30-days
Secondary	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
Secondary	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
Secondary	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
Secondary	Patients with resolution of non-digestive symptoms	Percentage of patients with improvement between the initial and final visits	30 days