Antiviral Efficacy and Acceptability of Mouth Rinses for Inactivation of COVID-19 — COL  

COVID19 Clinical Trial

Official title: Antiviral Efficacy and Acceptability of Therapeutic Antiseptic Mouth Rinses for Inactivation of COVID SARS-2 Virus

Status Terminated

Clinical Trial Summary

Subjects (125) will be randomized to one of five mouthrinses and will be asked to give a saliva sample immediately before and after a 30-60 second mouthwash.

Saliva samples will be collected from subjects at 15-minute intervals thereafter up to one hour (15, 30, 45 and 60 min). The saliva will be used for RT-PCR detection of Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) and viral infectivity assays, along with quantitative cytokine and chemokine concentration (pg/mL, Luminex).

Subjects will complete a short survey on the taste and experience of using the mouthwash.

Peripheral blood will be collected at the end of salivary collection. Subjects, except controls, will be provided materials and oral hygiene instruction related to daily use of oral hygiene products. In the seven-day period between study visit one and study visit two, subjects will be directed to brush with Colgate toothpaste (at least twice per day) and rinse with the Colgate mouthrinse (according to on-label procedures). Controls are asked to carry out their typical oral hygiene regimen with the products they typically use.

All subjects keep a daily diary of oral hygiene performance, product usage, COVID-19 symptoms and exposures. Subjects complete study visit two one week after the baseline visit during which additional salivary (1 time point, 2 mL of saliva over 5 min, no rinse) will occur and blood samples collected. each subject will undergo a periodontal exam.

Clinical Trial Description

Randomized, double-blind prospective trial to test the efficacy and acceptability of therapeutic, antiseptic mouth rinses to inactivate SARS-CoV-2 virus in saliva of SARS-CoV-2+ patients 18-65 years of age. The study will enroll 30 outpatient SARS-CoV-2+ subjects per mouth rinse, (to achieve a total of 25 subjects with full data sets per mouth rinse,) with 5 mouth rinses, requiring us to enroll 125 SARS-CoV-2+ patients. Patients will be randomized to their mouthrinse. These patients will have already had a confirmed SARS-CoV-2+ test prior to enrollment. There will be no stratification to our randomization. All mouthrinses are commercially available Colgate products and will be used according to on-label instructions.

Subjects will be randomized to a mouthrinse and will be asked to give a saliva sample immediately before and after a 30-60 second mouthwash.

Saliva samples will be collected from subjects at 15-minute intervals thereafter up to one hour (15, 30, 45 and 60 min). The saliva samples will be stored and used for RT-PCR detection of SARS-CoV-2 virus and viral infectivity assays, along with quantitative cytokine and chemokine concentration (pg/mL, Luminex).

Subjects will also complete a short survey on the taste and experience of using the mouthwash.

Peripheral blood will be collected at the end of salivary collection. Subjects, except controls, will be provided materials and oral hygiene instruction related to daily use of oral hygiene products provided by the study. In the seven-day period between study visits, subjects will be directed to brush with Colgate toothpaste (at least twice per day) and rinse with the Colgate mouthrinse (according to on-label procedures). Controls are not given Colgate products and will be asked to carry out their typical oral hygiene regimen with the products they typically use. All subjects will be asked to keep a daily diary of oral hygiene performance, product usage, COVID-19 symptoms and exposures.

Subjects will be scheduled to return to the research clinic at one week after the baseline assessment, during which additional salivary (1 time point, 2 mL of saliva over 5 min, no rinse will occur) and blood samples will be collected. At the conclusion of sample collection, the subject will undergo a periodontal exam. Study participation concludes following the periodontal exam at the end of the second on site study visit. Patients with any periodontitis or gingivitis diagnosis will be informed of their diagnosis and will be referred to an oral healthcare provider for further treatment. This study involves two 90-minute visits. ;

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infection
• Coronavirus Infections
• COVID-19
• COVID19
• Infections
• SARS CoV-2 Infection

• NCT number: NCT04748783
• Study type: Interventional
• Source: University of North Carolina, Chapel Hill
• Status: Terminated
• Phase: Phase 2
• Start date: March 26, 2021
• Completion date: April 7, 2021