A Study to Evaluate the Efficacy of Xlear vs. Placebo for... | NCT04858620

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

NCT04858620

Sponsor

Larkin Community Hospital

Status

Withdrawn

Last Update Posted

Oct 16, 2023Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Covid19

Interventions

Xlear Nasal Spray
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study Period Ended / Not Completed

Expanded Access Info

Start Date

Aug 30, 2020Actual

Primary Completion Date

Aug 30, 2021Estimated

Completion Date

Aug 30, 2021Estimated

First Submitted Date

Feb 4, 2021

First Submission Date that Met QC Criteria

Apr 22, 2021

First Posted Date

Apr 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2023

Last Update Posted Date

Oct 16, 2023Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Xlear Nasal Spray	Drug	Xylitol plus Grapefruit Seed Extract (Xlear) nasal spray, 2 puffs per nostrils, every 6 hours	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline and 7 days

Secondary Outcomes

Measure	Description	Time Frame
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.	Baseline and 7 days
Change of symptoms

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections