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

Larkin Community Hospital

Status and phase: Withdrawn; Phase 3

Conditions: Covid19

Treatments: Drug: Placebo; Drug: Xlear Nasal Spray

Study type: Interventional

Funder types: Other

Identifiers

NCT04858620

LCH-3-032020

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 3 patient groups, including a placebo group

No treatment

No Intervention group

Treatment

Experimental group

Treatment:

Drug: Xlear Nasal Spray

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo