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

Not Applicable

Completed

• Conditions: COVID-19; Coronavirus Infection
• Interventions: Dietary Supplement: Probiotic

• Registration Number: NCT04390477
• Lead Sponsor: Bioithas SL

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.

Study Timeline

• Study Start: 2020-05-04
• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-14
• Study First Posted: 2020-05-15
• Primary Completion: 2021-03-21
• Study Completion: 2021-04-30
• Status Verified: 2021-07
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	1 pill od containing 1x10E9 cfu of the probiotic

Primary Outcome Measures

Name	Time	Method
Cases with discharge to ICU.	30-days	Percentage of patients with discharge to ICU.
Patients with resolution of digestive symptoms	30 days	Percentage of patients with improvement between the initial and final visits

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Hospital Universitario del Vinalopó; 🇪🇸 Elche, Alicante, Spain

Hospital Universitario de Torrevieja; 🇪🇸 Torrevieja, Alicante, Spain