drugset
drugset / Trial / NCT04748783

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

NCT04748783 ↗

Phase 2 Terminated 2 enrolled University of North Carolina, Chapel Hill Colgate Palmolive · collab
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2021-03-26
Primary completion
2021-04-07
Completion
2021-04-07

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Chlorhexidine gluconate Other / unclassified 10 ml Oral

Indications

COVID-19