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

• ClinicalTrials.gov Identifier: NCT04858620
• Recruitment Status: Withdrawn
• First Posted: April 26, 2021
• Last Update Posted: October 14, 2021
• Sponsor: Larkin Community Hospital
• Information provided by (Responsible Party): Gustavo Ferrer, M.D., Larkin Community Hospital

Tracking Information

• First Submitted Date: February 4, 2021
• First Posted Date: April 26, 2021
• Last Update Posted Date: October 14, 2021
• Actual Study Start Date: August 30, 2020
• Estimated Primary Completion Date: August 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 22, 2021)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 22, 2021)

• 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.
• 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."
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Care Provider)
Masking Description:

Masking to care providers

Primary Purpose: Treatment

• Condition: Covid19

Intervention

• Drug: Xlear Nasal Spray
  Xylitol plus Grapefruit Seed Extract (Xlear) nasal spray, 2 puffs per nostrils, every 6 hours
• Drug: Placebo
  Saline nasal spray, 2 puffs per nostrils, every 6 hours

Study Arms

• No Intervention: No treatment
• Experimental: Treatment
  Intervention: Drug: Xlear Nasal Spray
• Placebo Comparator: Placebo
  Saline nasal spray, 2 puffs per nostrils, every 6 hours
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: October 6, 2021): 0
• Original Estimated Enrollment (submitted: April 22, 2021): 200
• Estimated Study Completion Date: August 30, 2021
• Estimated Primary Completion Date: August 30, 2021 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04858620
• Other Study ID Numbers: LCH-3-032020
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Gustavo Ferrer, M.D., Larkin Community Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Larkin Community Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Larkin Community Hospital
• Verification Date: October 2021