Covid19Phase 3NCT04854486
Impact of GSE and Xylitol (Xlear) on COVID-19 Symptoms and Time to PCR Negativisation in COVID-19 Patients
A Phase 3 study testing GSE and Xylitol in people with Covid19, run by Larkin Community Hospital at 2 sites in United States.
Trial summary
This clinical trial aims to ascertain the impact of GSE and Xylitol (XLEAR) in decreasing the time of negativisation in PCR testing in patients with COVID-19. 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?
- GSE and Xylitol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Dec 2021to 16 Nov 2022
- 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
- 1- Mild symptoms: Minimum respiratory symptoms or asymptomatic plus positive test
- 2- 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 2lt of oxygen)
Who cannot join
- Patients with Severe symptoms: Hypoxia (SpO2 <88% not corrected by 2 lt nc oxygen) plus severe shortness of breath (excluded)
- Patient with very low viral load (threshold cycle [Ct] > 25 per PCR).
- Known hypersensitivity to one of the constituents, particularly to xylitol or 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Larkin Community Hospital Palm Springs Campus
Miami, Florida, 33012
Larkin Community Hospital
Miami, Florida, 33143
About this study
Official title: Impact of GSE and Xylitol (Xlear) in Symptoms and Time to PCR Negativisation of Patients With Acute COVID-19 Infection
This clinical trial aims to ascertain the impact of GSE and Xylitol (XLEAR) in decreasing the time of negativisation in PCR testing in patients with COVID-19.
- Conditions
- Covid19
- Being tested
- GSE and Xylitol, Control Placebo
- Keywords
- intranasal spray, Covid19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSE and XylitolOther
Participants are given the experimental treatment to be used for 7 days.
Control PlaceboDrug
Saline
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Xylitol + GSE Receives: Other: GSE and Xylitol |
| Control placebo | Placebo comparator | Saline Receives: Drug: Control Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of time to negativisation via PCR
There will be a change in the time to negativisation via PCR as compared to the average 14-day time to negative result.
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 posted22 Apr 2021
- Study start16 Dec 2021
- Primary completion30 Mar 2022
- Study completion16 Nov 2022
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
- Parallel groups
- Model description
- Placebo controlled
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- 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
- NCT04854486
- Sponsor's protocol ID
- LCH-2-112020
- Status last verified
- Oct 2023
- First submitted
- 17 Apr 2021
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
- Impact of GSE and Xylitol (Xlear) in Symptoms and Time to PCR Negativisation of Patients With Acute COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04854486
- Acronym / sponsor ID
- LCH-2-112020
- Conditions
- Covid19
- Keywords
- intranasal spray, 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
- 16 Dec 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 22 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 clinical trial aims to ascertain the impact of GSE and Xylitol (XLEAR) in decreasing the time of negativisation in PCR testing in patients with COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: GSE and XylitolXylitol + GSE |
| Control placebo | Placebo comparator | Drug: Control PlaceboSaline |
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
- 1- Mild symptoms: Minimum respiratory symptoms or asymptomatic plus positive test
- 2- 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 2lt of oxygen)
Key exclusion criteria (13 listed)
- Patients with Severe symptoms: Hypoxia (SpO2 <88% not corrected by 2 lt nc oxygen) plus severe shortness of breath (excluded)
- Patient with very low viral load (threshold cycle [Ct] > 25 per PCR).
- Known hypersensitivity to one of the constituents, particularly to xylitol or 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.
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 |
|---|---|---|
| GSE and XylitolParticipants are given the experimental treatment to be used for 7 days. | Other | Treatment Group |
| Control PlaceboSaline | Drug | Control placebo |
Primary outcome
Change of time to negativisation via PCR
Time frame: Baseline and 7 days
There will be a change in the time to negativisation via PCR as compared to the average 14-day time to negative result.
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.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GSE and Xylitol in people with Covid19, run by Larkin Community Hospital at 2 sites 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 13 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 2 sites 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?
Change of time to negativisation via 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.