NCT04858620

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2020

Typical duration for phase_3 covid19

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

February 4, 2021

Last Update Submit

October 12, 2023

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • Change of symptoms

    Baseline and 7 days

  • Change of symptoms

    Baseline and 7 days

  • Change of symptoms

    Baseline and 7 days

Study Arms (3)

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

Xlear Nasal SprayDRUG

Xylitol plus Grapefruit Seed Extract (Xlear) nasal spray, 2 puffs per nostrils, every 6 hours

Treatment
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Larkin Community Hospital

Miami, Florida, 33143, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Masking to care providers
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2021

First Posted

April 26, 2021

Study Start

August 30, 2020

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

October 16, 2023

Record last verified: 2023-10

Locations

US(1)