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Impact of GSE and Xylitol (Xlear) on COVID-19 Symptoms and Time to PCR Negativisation in COVID-19 Patients

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: NCT04854486
Recruitment Status : Not yet recruiting
First Posted : April 22, 2021
Last Update Posted : October 14, 2021
Sponsor:
Information provided by (Responsible Party):
Gustavo Ferrer, M.D., Larkin Community Hospital

Study Description
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Brief Summary:
This clinical trial aims to ascertain the impact of GSE and Xylitol (XLEAR) in decreasing the time of negativisation in PCR testing in patients with COVID-19.

Condition or disease Intervention/treatment Phase
Covid19 Other: GSE and Xylitol Drug: Control Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Placebo controlled
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of GSE and Xylitol (Xlear) in Symptoms and Time to PCR Negativisation of Patients With Acute COVID-19 Infection
Estimated Study Start Date : December 16, 2021
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : November 16, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Xylitol

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Group
Xylitol + GSE
 Other: GSE and Xylitol
Participants are given the experimental treatment to be used for 7 days.
Placebo Comparator: Control placebo
Saline
 Drug: Control Placebo
Saline


Outcome Measures
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Primary Outcome Measures :
  1. Change of time to negativisation via PCR [ Time Frame: Baseline and 7 days ]
    There will be a change in the time to negativisation via PCR as compared to the average 14-day time to negative result.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Adults of ages 18 to 90 years of both sexes
  • With positive SARS-CoV-2 carriage confirmed by nasopharyngeal PCR
  • Signed informed consent
  • 1- Mild symptoms: Minimum respiratory symptoms or asymptomatic plus positive test
  • 2- Moderate symptoms: Respiratory symptoms such as cough, mild shortness of breath with mild oxygen desaturation(room air SpO2 <92% and >88% or <88% corrected to >92% with 2lt of oxygen)

Exclusion Criteria

  • Patients with Severe symptoms: Hypoxia (SpO2 <88% not corrected by 2 lt nc oxygen) plus severe shortness of breath (excluded)
  • Patient with very low viral load (threshold cycle [Ct] > 25 per PCR).
  • Known hypersensitivity to one of the constituents, particularly to xylitol or GSE
  • Under 18 years of age
  • Women of childbearing age who are pregnant, breastfeeding mothers, and intend to become pregnant during the study period; unwilling/unable to take a pregnancy test.
  • Unable to provide informed consent or decline to consent or unwillingness to adhere to the Standard of Care protocol.
  • Patients with severe symptoms -Hypoxia (SpO2 <88% not corrected by 2 liter non- concentrated oxygen) plus severe shortness of breath
  • History of immunodeficiency or are currently receiving immunosuppressive therapy.
  • Have had a planned surgical procedure within the past 12 weeks.
  • Already part of this trial, recruited at a different hospital.
  • Patient unable to perform oro-nasopharyngeal decolonization
  • Patients with acute exacerbation of severe comorbidities like heart disorders Chronic Obstructive Pulmonary Disease (COPD), Heart Failure New York Heart Association (NYHA) Class 3 and 4 and/or diseases with severe oxygenation problems
  • Patients on Remdesivir and/or other clinical trials.
Contacts and Locations
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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): NCT04854486


Contacts
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Contact: Roboam R Aguirre, MD, DBA 305-284-7608 raguirre@larkinhospital.com

Locations
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United States, Florida
Larkin Community Hospital Palm Springs Campus
Miami, Florida, United States, 33012
Contact: Roboam R Aguirre, MD, DBA    305-284-7608    raguirre@larkinhospital.com   
Contact: Marcos Sanchez-Gonzalez, MD, PhD       masanchez@larkinhospital.com   
Larkin Community Hospital
Miami, Florida, United States, 33143
Contact: Roboam R Aguirre, MD, DBA    305-284-7608    raguirre@larkinhospital.com   
Contact: Marcos Sanchez-Gonzalez, MD, PhD       masanchez@larkinhospital.com   
Principal Investigator: Gustavo Ferrer, M.D.         
Sponsors and Collaborators
Larkin Community Hospital
More Information
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Responsible Party: Gustavo Ferrer, M.D., Principal Investigator, Larkin Community Hospital
ClinicalTrials.gov Identifier: NCT04854486    
Other Study ID Numbers: LCH-2-112020
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Gustavo Ferrer, M.D., Larkin Community Hospital:
intranasal spray
Covid19
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases