Antiviral Efficacy and Acceptability of Mouth Rinses for Inactivation of COVID-19
Status:
Terminated
Trial end date:
2021-04-07
Target enrollment:
Participant gender:
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.