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A Study to Evaluate the Efficacy of Xlear vs. Placebo for Acute COVID-19 Infection

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04858620
Recruitment Status : Withdrawn (no patients enrolled)
First Posted : April 26, 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 study aims to find out the efficacy of Xlear nasal spray as an adjunct medication against COVID-19. This encompasses reduction in the number of days to negativization via nasal swab PCR from the average 14 days and early improvement of symptoms.

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

Detailed Description:
Patients will be informed about the study including potential risk and benefits. Once written informed consent are obtained, patients will undergo a brief screening period to determine eligibility for the study. Once eligibility is confirmed, eligible patients will be placed in a randomized placebo control manner. Patient will be assigned to Xlear (2 puffs per nostrils, 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 Reverse Transcriptase PCR (RT PCR) on Day 7. Follow up will be done on Day 14 for all patients.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 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 Xlear vs. Placebo for Acute COVID-19 Infection
Actual Study Start Date : August 30, 2020
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: No treatment
Experimental: Treatment Drug: Xlear Nasal Spray
Xylitol plus Grapefruit Seed Extract (Xlear) nasal spray, 2 puffs per nostrils, every 6 hours
Placebo Comparator: Placebo
Saline nasal spray, 2 puffs per nostrils, every 6 hours
 Drug: Placebo
Saline nasal spray, 2 puffs per nostrils, every 6 hours


Outcome Measures
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Primary Outcome Measures :
  1. Hasten baseline reactive to non-reactive on COVID 19 RT PCR [ Time Frame: Baseline and 7 days ]
    The COVID 19 RT PCR is the gold standard in the detection of COVID 19 in patients. With the average time to negativization being 14 days. This study aims to reduce the reactivity to 7 days.


Secondary Outcome Measures :
  1. Change of symptoms [ Time Frame: Baseline and 7 days ]
    Monitor changes in daily symptoms for COVID 19 positive patients using Symptom Assessment Scale (SAS). Symptoms are classified as Mild, Moderate, Severe.

  2. Change of symptoms [ Time Frame: Baseline and 7 days ]
    Monitor changes in daily symptoms for COVID 19 positive patients using Visual Analogue Scale (VAS). Symptoms are classified using a a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

  3. Change of symptoms [ Time Frame: Baseline and 7 days ]
    Monitor changes in daily symptoms for COVID 19 positive patients using Numerical Rating Scale (NRS). Symptoms are classified from 1-10, with 1 being no symptoms and 10 worst symptoms.


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:

  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. Mild symptoms: Minimum respiratory symptoms or asymptomatic plus positive test
  5. 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 2 liters 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 grapefruit seed extract (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.
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): NCT04858620


Locations
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United States, Florida
Larkin Community Hospital
Miami, Florida, United States, 33143
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: NCT04858620    
Other Study ID Numbers: LCH-3-032020
First Posted: April 26, 2021    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases