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| Name | Class |
|---|---|
| Dentaid SL | INDUSTRY |
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Pilot, randomized and controlled clinical trial for the evaluation of the decrease in the viral load of SARS-CoV-2 in the oropharynx in patients with COVID-19 through the use of mouthwash containing cetylpyridinium chloride (CPC) (0.07%) in mouthwash.
The objective of the clinical trial is to determine the short-term efficacy of cetylpyridinium chloride (CPC) mouthwashes to assess changes in the threshold cycle value of the analysis of the SARS-CoV-2 oropharyngeal saliva sample, in patients diagnosed with COVID-19 and with symptomatology compatible with the disease. A randomized double-blind pilot clinical trial (evaluator and patients) will be developed in patients with a diagnosis of COVID-19 and symptoms of the disease. The experimental group will perform a single rinse with a mouthwash containing Cetylpyridinium Chloride (CPC) while the placebo group will perform the same rinse, but with a harmless liquid that will act as a placebo. The study will be carried out in the Zaragoza III Health Sector, with patients belonging to the Zaragoza II Health Sector, collaborating with the "Seminario" health center and the Lozano Blesa Clinical University Hospital (HCULB). This project will be carried out in accordance with the CONSORT guidelines for clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cetylpyridinium Chloride (CPC) 0,07% | Experimental | patients who rinse with cetylpyiridinium chloride 0,07% mouthwash for 60 seconds |
|
| Placebo: Distilled water with the same flavor and coloring as the product to be evaluated | Placebo Comparator | patients who rinse with distilled water mouthwash for 60 seconds |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDE | Other | one mouthwash containing cetylpyridinium chloride (0.07%) for 60 seconds |
|
| Measure | Description | Time Frame |
|---|---|---|
| Threshold cycle value of SARS-CoV-2 by Polymerase Chain Reaction (PCR) in saliva samples | Threshold cycle value of SARS-CoV-2 by Polymerase Chain Reaction (PCR) in saliva samples before antd 2hours after mouthwashes | 3 months |
| SARS-CoV-2 Nucleocapsid protein in saliva by ELISA | Quantitative determination of SARS-CoV-2 Nucleocapsid protein in saliva by ELISA | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seminario Health Center and Lozano Blesa University Clinical Hospital | Zaragoza | 50009 | Spain |
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Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 40 subjects in the first group and 40 in the second were required to detect a difference equal to or greater than 5 units. The common standard deviation is assumed to be 10 (12). A loss to follow-up rate of 20% has been estimated.
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Randomized double-blind pilot clinical trial (evaluator and patients) in patients with a diagnosis of COVID-19 and symptoms of the disease.
| PLACEBO | Other | one mouthwash containing distilled (placebo) water for 60 seconds |
|
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| D002594 | Cetylpyridinium |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D011726 | Pyridinium Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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