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

Withdrawn before enrolling · Phase 3 · Has a placebo group

Conditions studied: Covid19

In brief

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.

Key facts

Study ID

NCT04858620

Run by

Larkin Community Hospital

People needed

0

Starts

2020-08-30

Expected to finish

2021-08-30

Last updated by the study team

2023-10-16

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Larkin Community Hospital — Miami, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.