A Study to Evaluate the Efficacy of Xlear vs. Placebo for Acute COVID-19 Infection
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ClinicalTrials.gov Identifier: NCT04858620 |
Recruitment Status :
Withdrawn
(no patients enrolled)
First Posted : April 26, 2021
Last Update Posted : October 14, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Covid19 | Drug: Xlear Nasal Spray Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
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 : | August 30, 2020 |
Estimated Primary Completion Date : | August 30, 2021 |
Estimated Study Completion Date : | August 30, 2021 |

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
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Drug: Placebo
Saline nasal spray, 2 puffs per nostrils, every 6 hours |
- Hasten baseline reactive to non-reactive on COVID 19 RT PCR [ Time Frame: 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.
- Change of symptoms [ Time Frame: 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.
- Change of symptoms [ Time Frame: 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."
- Change of symptoms [ Time Frame: 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04858620
United States, Florida | |
Larkin Community Hospital | |
Miami, Florida, United States, 33143 |
Responsible Party: | Gustavo Ferrer, M.D., Principal Investigator, Larkin Community Hospital |
ClinicalTrials.gov Identifier: | NCT04858620 |
Other Study ID Numbers: |
LCH-3-032020 |
First Posted: | April 26, 2021 Key Record Dates |
Last Update Posted: | October 14, 2021 |
Last Verified: | October 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 |
COVID-19 Infections Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |