Study to Evaluate the Effect of a Probiotic in COVID-19
The Intestinal Microbiota as a Therapeutic Target in Hospitalized Patients With COVID-19 Infection
1 other identifier
interventional
41
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable covid19
Started May 2020
Typical duration for not_applicable covid19
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 4, 2020
CompletedFirst Submitted
Initial submission to the registry
May 7, 2020
CompletedFirst Posted
Study publicly available on registry
May 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedApril 29, 2022
July 1, 2021
11 months
May 7, 2020
April 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cases with discharge to ICU.
Percentage of patients with discharge to ICU.
30-days
Patients with resolution of digestive symptoms
Percentage of patients with improvement between the initial and final visits
30 days
Secondary Outcomes (6)
Patients with home discharge.
30-days
Mortality.
30-days
Treatment safety assessed by number of adverse events.
30-days
New cases of SARS-Cov-2 infection among healthcare personnel caring for the patients.
30-days
Patients with negative PCR and/or Antigen test result for SARS-CoV-2 infection.
10-15 days
- +1 more secondary outcomes
Study Arms (2)
Probiotic
EXPERIMENTAL1 pill od containing 1x10E9 cfu of the probiotic
Control
NO INTERVENTIONNo treatment
Interventions
Oral daily capsule containing probiotic strains with maltodextrin as excipient, administrated for 30 days.
Eligibility Criteria
You may qualify if:
- Patients with a confirmed diagnosis of SARS-Cov.2 infection using the PCR and that require admission to the hospitalization area.
You may not qualify if:
- Inability or refusal to sign informed consent.
- Allergy or intolerance to the intervention product or its components.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bioithas SLlead
Study Sites (2)
Hospital Universitario del Vinalopó
Elche, Alicante, 03293, Spain
Hospital Universitario de Torrevieja
Torrevieja, Alicante, 03198, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vicente Navarro
Hospital universitario del Vinalopo, Elche, Spain
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Random numbers table. One branch placebo and other one no intervention
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2020
First Posted
May 15, 2020
Study Start
May 4, 2020
Primary Completion
March 21, 2021
Study Completion
April 30, 2021
Last Updated
April 29, 2022
Record last verified: 2021-07