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

• Sponsor: Larkin Community Hospital (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT04858620
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 0

Study Details

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.

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

• Study Type: Interventional
• 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: Aug 30, 2020
• Anticipated Primary Completion Date: Aug 30, 2021
• Anticipated Study Completion Date: Aug 30, 2021

Arms and Interventions

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

Primary Outcome Measures

1. Hasten baseline reactive to non-reactive on COVID 19 RT PCR [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Larkin Community Hospital	Miami	Florida	United States	33143

Sponsors and Collaborators

• Larkin Community Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gustavo Ferrer, M.D., Principal Investigator, Larkin Community Hospital
• ClinicalTrials.gov Identifier: NCT04858620
• Other Study ID Numbers: LCH-3-032020
• First Posted: Apr 26, 2021
• Last Update Posted: Oct 14, 2021
• Last Verified: Oct 1, 2021

• 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: COVID-19

Study Results

No Results Posted as of Oct 14, 2021