Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-30 @ 8:47 AM
Study NCT ID:
NCT04931004
Status:
UNKNOWN
Last Update Posted:
2021-06-23
First Post:
2021-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Rinse to Reduced Expelled Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) During COVID-19 Infection
Sponsor:
Rutgers, The State University of New Jersey
Organization:
Study Overview
Official Title:
Effect of Oral Hygiene Products on Reducing Expelled/Exhaled SARS-CoV-2
Status:
UNKNOWN
Status Verified Date:
2021-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective, cross-sectional study evaluating the effect of commercially available mouthwashes on expelled/exhaled SARS-CoV-2 viral load using face mask sampling.
Detailed Description:
The study will consist of a Control Phase to optimize procedures for measuring expelled/exhaled viral load, and a Evaluation phase comparing different commercially available mouthwashes.
In the Control Phase. up to 20 COVID-19 patients will be asked to undergo a sequence of face mask sampling and saliva collections prior to and after an oral rinse with (i) water and (ii) a commercially-available cetylpyridinium chloride (CPC) mouthwash.
Based on outcomes of the Control Phase, the study will proceed into the Evaluation Phase, which will randomize approximately 40 COVID-19 patients to receive 1 of 4 commercially available Colgate mouthwashes following standard package instructions. Face mask sampling and saliva will be collected prior to and after the mouth rinse to assess impact on SARS-CoV-2 viral load.
In the Control Phase. up to 20 COVID-19 patients will be asked to undergo a sequence of face mask sampling and saliva collections prior to and after an oral rinse with (i) water and (ii) a commercially-available cetylpyridinium chloride (CPC) mouthwash.
Based on outcomes of the Control Phase, the study will proceed into the Evaluation Phase, which will randomize approximately 40 COVID-19 patients to receive 1 of 4 commercially available Colgate mouthwashes following standard package instructions. Face mask sampling and saliva will be collected prior to and after the mouth rinse to assess impact on SARS-CoV-2 viral load.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: