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Trial record 2 of 16 for:    probiotics | covid19

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04390477
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
COVID-19 Coronavirus Infection Dietary Supplement: Probiotic Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Random numbers table. One branch placebo and other one no intervention
Primary Purpose: Treatment
Official Title: The Intestinal Microbiota as a Therapeutic Target in Hospitalized Patients With COVID-19 Infection
Actual Study Start Date : May 4, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Probiotic
1 pill od containing 1x10E9 cfu of the probiotic
Dietary Supplement: Probiotic
Oral daily capsule containing probiotic strains with maltodextrin as excipient, administrated for 30 days.

No Intervention: Control
No treatment



Primary Outcome Measures :
  1. Cases with discharge to ICU. [ Time Frame: 30-days ]
    Percentage of patients with discharge to ICU.


Secondary Outcome Measures :
  1. Patients with home discharge. [ Time Frame: 30-days ]
    Percentage of patients with home discharge.

  2. Mortality. [ Time Frame: 30-days ]
    Percentage of deaths.

  3. Treatment safety assessed by number of adverse events. [ Time Frame: 30-days ]
    Number of adverse events that occur during the treatment period, attributable or not to the intervention product.

  4. New cases of SARS-Cov-2 infection among healthcare personnel caring for the patients. [ Time Frame: 30-days ]
    Number of new cases of positive SARS-Cov-2 infection by PCR analysis.

  5. Patients with negative PCR result for SARS-CoV-2 infection. [ Time Frame: 30-days ]
    Percentage of patients with negative PCR for SARS-CoV-2.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04390477


Contacts
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Contact: Laura Navarro 0034623022586 laura.navarro@bioithas.com

Locations
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Spain
Hospital Universitario del Vinalopó Recruiting
Elche, Alicante, Spain, 03293
Contact: Vicente Navarro    968278800    vnavarro@vinaloposalud.com   
Principal Investigator: Maria Isabel Perez-Soto         
Hospital Universitario de Torrevieja Recruiting
Torrevieja, Alicante, Spain, 03198
Contact: Vicente Navarro    965721200    vnavarro@vinaloposalud.com   
Principal Investigator: Maykel Ayo-González         
Sponsors and Collaborators
Bioithas SL
Investigators
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Principal Investigator: Vicente Navarro Hospital universitario del Vinalopo, Elche, Spain
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Responsible Party: Bioithas SL
ClinicalTrials.gov Identifier: NCT04390477    
Other Study ID Numbers: COVID.PROB
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bioithas SL:
Probiotic
Additional relevant MeSH terms:
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Infection
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases