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Study Period Ended/ Not Completed
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| Name | Class |
|---|---|
| Ferrer Medical Innovations | UNKNOWN |
| Xlear, Inc | INDUSTRY |
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The purpose of this study is to assess the efficacy of Xylitol plus Grapefruit Seed Extract (Xlear) nasal spray as an adjunct treatment of COVID-19.
After being informed about the study and potential risk, all patients giving written informed consent will undergo a brief screening period to determine eligibility for the study. Once eligibility is confirmed, patients who meet the eligibility requirements will be randomized placebo control manner. Patient will be assigned to Xlear (2 puffs per nosetrils, 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 RT PCR on Day 7. Follow up will be done on Day 14 for all patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No treatment | No Intervention | No treatment given | |
| Treatment | Experimental | Xylitol plus Grapefruit Seed Extract (Xlear) nasal spray, 2 puffs per nosetrils, every 6 hours |
|
| Placebo | Placebo Comparator | Saline nasal spray, 2 puffs per nosetrils, every 6 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal Spray | Drug | Randomized to placebo and Xlear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline reactive to non-reactive on COVID 19 RT PCR in 7 days | The COVID 19 RT PCR is the gold standard in detecting presence of COVID-19 in patients. The average time from reactivity to non-reactivity is 14 days, | Baseline and 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change of time to clinical recovery from baseline within 7 days | Change in clinical symptoms including but not limited to agnosmia, ageusia, fever, congestion and other clinical symptoms associated with mild COVID-19 infection. | Baseline and 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gustavo Ferrer, MD | Larkin Community Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Larkin Community Hospital Palm Springs Campus | Miami | Florida | 33012 | United States | ||
| Larkin Community Hospital |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D059085 | Nasal Sprays |
| C000716727 | xylitol and grapefruit seed extract drug combination |
| ID | Term |
|---|---|
| D000336 | Aerosols |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 |
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Masking to care providers
| Miami |
| Florida |
| 33143 |
| United States |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Pharmaceutical Preparations |