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

Primary Purpose

Covid19

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Xlear Nasal Spray
Placebo
Sponsored by
Larkin Community Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Larkin Community Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Placebo Comparator

Arm Label

No treatment

Treatment

Placebo

Arm Description

Saline nasal spray, 2 puffs per nostrils, every 6 hours

Outcomes

Primary Outcome Measures

Hasten baseline reactive to non-reactive on COVID 19 RT PCR
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

Change of symptoms
Monitor changes in daily symptoms for COVID 19 positive patients using Symptom Assessment Scale (SAS). Symptoms are classified as Mild, Moderate, Severe.
Change of symptoms
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."
Change of symptoms
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.

Full Information

First Posted
February 4, 2021
Last Updated
October 12, 2023
Sponsor
Larkin Community Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04858620
Brief Title
A Study to Evaluate the Efficacy of Xlear vs. Placebo for Acute COVID-19 Infection
Official Title
A Randomized Placebo Control Trial to Evaluate the Efficacy of Xlear vs. Placebo for Acute COVID-19 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Study Period Ended / Not Completed
Study Start Date
August 30, 2020 (Actual)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
August 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Larkin Community Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Care Provider
Masking Description
Masking to care providers
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No treatment
Arm Type
No Intervention
Arm Title
Treatment
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline nasal spray, 2 puffs per nostrils, every 6 hours
Intervention Type
Drug
Intervention Name(s)
Xlear Nasal Spray
Intervention Description
Xylitol plus Grapefruit Seed Extract (Xlear) nasal spray, 2 puffs per nostrils, every 6 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline nasal spray, 2 puffs per nostrils, every 6 hours
Primary Outcome Measure Information:
Title
Hasten baseline reactive to non-reactive on COVID 19 RT PCR
Description
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.
Time Frame
Baseline and 7 days
Secondary Outcome Measure Information:
Title
Change of symptoms
Description
Monitor changes in daily symptoms for COVID 19 positive patients using Symptom Assessment Scale (SAS). Symptoms are classified as Mild, Moderate, Severe.
Time Frame
Baseline and 7 days
Title
Change of symptoms
Description
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."
Time Frame
Baseline and 7 days
Title
Change of symptoms
Description
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.
Time Frame
Baseline and 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 Mild symptoms: Minimum respiratory symptoms or asymptomatic plus positive test 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: Patient with very low viral load (threshold cycle [Ct] > 25 per PCR). Known hypersensitivity to one of the constituents, particularly to xylitol or grapefruit seed extract (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.
Facility Information:
Facility Name
Larkin Community Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States

12. IPD Sharing Statement

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

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