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Evaluation of the Efficacy of Xylitol Nasal Spray Against SARS-CoV-2

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ClinicalTrials.gov Identifier: NCT04610801
Recruitment Status : Recruiting
First Posted : November 2, 2020
Last Update Posted : November 10, 2020
Sponsor:
Collaborators:
Ferrer Medical Innovations
Xlear
Information provided by (Responsible Party):
Gustavo Ferrer, M.D., Larkin Community Hospital

Brief Summary:
The purpose of this study is to assess the efficacy of Xylitol plus Grapefruit Seed Extract (Xlear) nasal spray as an adjunct treatment of COVID-19.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Nasal Spray Phase 3

Detailed Description:
After being informed about the study and potential risk, all patients giving written informed consent will undergo a brief screening period to determine eligibility for the study. Once eligibility is confirmed, patients who meet the eligibility requirements will be randomized placebo control manner. Patient will be assigned to Xlear (2 puffs per nosetrils, every 3-4 hours a day) or placebo. Patient will be followed for 1 week. Inflammatory markers will be obtained on Day 4 and repeat COVID-19 RT PCR on Day 7. Follow up will be done on Day 14 for all patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Care Provider)
Masking Description: Masking to care providers
Primary Purpose: Treatment
Official Title: A Randomized Placebo Control Trial to Evaluate the Efficacy of Xylitol Nasal Spray vs. Placebo for Acute COVID-19 Infection
Actual Study Start Date : August 8, 2020
Estimated Primary Completion Date : August 8, 2021
Estimated Study Completion Date : August 8, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Xylitol

Arm Intervention/treatment
No Intervention: No treatment
No treatment given
Experimental: Treatment
Xylitol plus Grapefruit Seed Extract (Xlear) nasal spray, 2 puffs per nosetrils, every 6 hours
Drug: Nasal Spray
Randomized to placebo and Xlear
Other Name: Xlear

Placebo Comparator: Placebo
Saline nasal spray, 2 puffs per nosetrils, every 6 hours
Drug: Nasal Spray
Randomized to placebo and Xlear
Other Name: Xlear




Primary Outcome Measures :
  1. Change from baseline reactive to non-reactive on COVID 19 RT PCR in 7 days [ Time Frame: Baseline and 7 days ]
    The COVID 19 RT PCR is the gold standard in detecting presence of COVID-19 in patients. The average time from reactivity to non-reactivity is 14 days,


Secondary Outcome Measures :
  1. Change of time to clinical recovery from baseline within 7 days [ Time Frame: Baseline and 7 days ]
    Change in clinical symptoms including but not limited to agnosmia, ageusia, fever, congestion and other clinical symptoms associated with mild COVID-19 infection.



Information from the National Library of Medicine

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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:

  1. Adults of ages 18 to 90 years of both sexes
  2. With positive SARS-CoV-2 carriage confirmed by nasopharyngeal PCR
  3. Signed informed consent
  4. 1- Mild symptoms: Minimum respiratory symptoms or asymptomatic plus positive test
  5. 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:

  1. Patient with very low viral load (threshold cycle [Ct] > 25 per PCR).
  2. Known hypersensitivity to one of the constituents, particularly to xylitol or GSE
  3. Under 18 years of age
  4. 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.
  5. Unable to provide informed consent or decline to consent or unwillingness to adhere to the Standard of Care protocol.
  6. Patients with severe symptoms -Hypoxia (SpO2 <88% not corrected by 2 liter non-concentrated oxygen) plus severe shortness of breath
  7. History of immunodeficiency or are currently receiving immunosuppressive therapy.
  8. Have had a planned surgical procedure within the past 12 weeks.
  9. Already part of this trial, recruited at a different hospital.
  10. Patient unable to perform oro-nasopharyngeal decolonization
  11. 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
  12. Patients on Remdesivir and/or other clinical trials.

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): NCT04610801


Locations
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United States, Florida
Larkin Community Hospital Palm Springs Campus Recruiting
Miami, Florida, United States, 33012
Contact: CAMILLE GO    786-654-9138    ccgo@larkinhospital.com   
Contact: Marcos Sanchez-Gonzalez       masanchez@larkinhospital.com   
Larkin Community Hospital Recruiting
Miami, Florida, United States, 33143
Contact: Camille Go, MD    786-654-9138    ccgo@larkinhospital.com   
Contact: Marcos Sanchez-Gonzalez, MD       masanchez@larkinhospital.com   
Sub-Investigator: Camille Celeste Go, M.D.         
Sponsors and Collaborators
Larkin Community Hospital
Ferrer Medical Innovations
Xlear
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Responsible Party: Gustavo Ferrer, M.D., Associate Professor, Larkin Community Hospital
ClinicalTrials.gov Identifier: NCT04610801    
Other Study ID Numbers: LCH-3-082020
First Posted: November 2, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
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:
Covid 19
Intranasal Spray
Therapeutics