Covid19Phase 3NCT04858620
A Study to Evaluate the Efficacy of Xlear vs. Placebo for Acute COVID-19 Infection
A Phase 3 study testing Xlear Nasal Spray in people with Covid19, run by Larkin Community Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Xlear Nasal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2020to 30 Aug 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Placebo Control Trial to Evaluate the Efficacy of Xlear vs. Placebo for Acute COVID-19 Infection
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Xlear Nasal Spray, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xlear Nasal SprayDrug
Xylitol plus Grapefruit Seed Extract (Xlear) nasal spray, 2 puffs per nostrils, every 6 hours
PlaceboDrug
Saline nasal spray, 2 puffs per nostrils, every 6 hours
| Study group | Role | What they receive |
|---|---|---|
| No treatment | No intervention | Not described |
| Treatment | Experimental | Not described Receives: Drug: Xlear Nasal Spray |
| Placebo | Placebo comparator | Saline nasal spray, 2 puffs per nostrils, every 6 hours Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 7 days
Secondary outcomes (3)
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.
Measured: Baseline and 7 days
Change of symptoms
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."
Measured: Baseline and 7 days
Change of symptoms
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.
Measured: Baseline and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start30 Aug 2020
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Why it stopped: Study Period Ended / Not Completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larkin Community Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858620
- Sponsor's protocol ID
- LCH-3-032020
- Status last verified
- Oct 2023
- First submitted
- 4 Feb 2021
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo Control Trial to Evaluate the Efficacy of Xlear vs. Placebo for Acute COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04858620
- Acronym / sponsor ID
- LCH-3-032020
- Conditions
- Covid19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study Period Ended / Not Completed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Larkin Community HospitalUniversity, hospital or other
- Study start
- 30 Aug 2020 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No treatment | No intervention | – |
| Treatment | Experimental | Drug: Xlear Nasal Spray |
| Placebo | Placebo comparator | Drug: PlaceboSaline nasal spray, 2 puffs per nostrils, every 6 hours |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xlear Nasal SprayXylitol plus Grapefruit Seed Extract (Xlear) nasal spray, 2 puffs per nostrils, every 6 hours | Drug | Treatment |
| PlaceboSaline nasal spray, 2 puffs per nostrils, every 6 hours | Drug | Placebo |
Primary outcome
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.
3 secondary outcomes
Change of symptoms
Time frame: Baseline and 7 days
Change of symptoms
Time frame: Baseline and 7 days
Change of symptoms
Time frame: Baseline and 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xlear Nasal Spray in people with Covid19, run by Larkin Community Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hasten baseline reactive to non-reactive on COVID 19 RT PCR (time frame: Baseline and 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023; AzTrials last refreshed its copy on 2 Nov 2026.