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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04390477
Other study ID # COVID.PROB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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