Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04757818
Status:
COMPLETED
Last Update Posted:
2021-07-19
First Post:
2021-02-16
Brief Title:
Double-blind Randomized Parallel Placebo-controlled Clinical Study to Evaluate the Viral Load of SARS-CoV-2 COVID-19 in the Oral Cavity of SARS-CoV-2 Positive Subjects After the Use of a Mouthwash Containing Cetylpyridinium Chloride 007
Sponsor:
Dentaid SL
Organization:
Dentaid SL
Study Overview
Official Title:
Double-blind Randomized Parallel Placebo-controlled Clinical Study to Evaluate the Viral Load of SARS-CoV-2 in the Oral Cavity of SARS-CoV-2 Positive Subjects After the Use of a Mouthwash Containing Cetylpyridinium Chloride 007
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
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:
CPC COVID
Brief Summary:
Double-blind parallel randomized placebo-controlled clinical study Subjects with confirmed SARS-CoV-2 infection by PCR or antigen rapid test asymptomatic or with mild COVID-19 symptoms will be included Subjects who agree to participate and who are eligible will be randomized to perform a mouth rinse and gargle with a 007 CPC mouthwash experimental or with a substance of the same color placebo Saliva samples will be collected at baseline ie before wash and 1 hour and 3 hours after wash Saliva samples will be transferred to a central laboratory for SARS-CoV-2 viral load determination nucleocapsid protein levels determination rapid antigen testing viral infectivity analysis and storage
Detailed Description:
Study procedures will be as follows
The study procedures will take place in 1 day total interval of 3 hours from the baseline sample collection to the last sample collection
The study samples will be saliva samples 1-15 ml collected at baseline and 1 and 3 hours after the intervention The intervention will be the use of a mouthwash washes and gargles for one minute with 15 ml of either CPC Protect CPC group or colored distilled water control group
Candidates with a positive result of PCR or antigen rapid test for SARS-CoV-2 will be identified by study nurses certified nursing assistants and dentists at primary health care centers of the Metro Nord health administrative region of Catalonia The investigator will obtain the candidates informed consent and will verify that the subject meets all the inclusion criteria and none of the exclusion criteria The researcher will assign a correlative kit number randomization and instruct the subject in the procedure of self-collection of a saliva sample
Baseline The subject will self-collect the baseline saliva sample in front of the investigator who will be able to correct the errors observed in the procedure
Hour 0 After the obtention of the baseline saliva sample the subject will rinse and gargle with 15 mL of mouthwash experimental or placebo for 1 minute 30 seconds of rinsing and 30 seconds of gargling
The researcher will indicate to the subject the hours in which the second and third saliva samples should be taken The subject must avoid brushing their teeth eating and drinking except water until the rest of the saliva samples are collected and may return home
Hour 1 One hour after mouthwash use the subject will self-collect the second saliva sample 1-hour sample
Hour 3 Three hours after mouthwash use the subject will self-collect the third saliva sample 3-hour sample
The investigator will contact the subject to confirm the correct collection of saliva samples 1 hour and 3 hours at the indicated times and will record it in the study application
Saliva samples will be collected at the center andor at the subjects residence and will be transferred to the Clinical Laboratory Metropolitana Nord in Hospital Universitari Germans Trias i Pujol HUGTiP for the viral load analysis by RT-PCR The remaining saliva volume will be transferred to IrsiCaixas Laboratory located in the HUGTiP for the ELISA analysis and the rest of the analysis and for storage in those cases where the subjects IC is available for it
The study procedures will take place in 1 day total interval of 3 hours from the baseline sample collection to the last sample collection
The study samples will be saliva samples 1-15 ml collected at baseline and 1 and 3 hours after the intervention The intervention will be the use of a mouthwash washes and gargles for one minute with 15 ml of either CPC Protect CPC group or colored distilled water control group
Candidates with a positive result of PCR or antigen rapid test for SARS-CoV-2 will be identified by study nurses certified nursing assistants and dentists at primary health care centers of the Metro Nord health administrative region of Catalonia The investigator will obtain the candidates informed consent and will verify that the subject meets all the inclusion criteria and none of the exclusion criteria The researcher will assign a correlative kit number randomization and instruct the subject in the procedure of self-collection of a saliva sample
Baseline The subject will self-collect the baseline saliva sample in front of the investigator who will be able to correct the errors observed in the procedure
Hour 0 After the obtention of the baseline saliva sample the subject will rinse and gargle with 15 mL of mouthwash experimental or placebo for 1 minute 30 seconds of rinsing and 30 seconds of gargling
The researcher will indicate to the subject the hours in which the second and third saliva samples should be taken The subject must avoid brushing their teeth eating and drinking except water until the rest of the saliva samples are collected and may return home
Hour 1 One hour after mouthwash use the subject will self-collect the second saliva sample 1-hour sample
Hour 3 Three hours after mouthwash use the subject will self-collect the third saliva sample 3-hour sample
The investigator will contact the subject to confirm the correct collection of saliva samples 1 hour and 3 hours at the indicated times and will record it in the study application
Saliva samples will be collected at the center andor at the subjects residence and will be transferred to the Clinical Laboratory Metropolitana Nord in Hospital Universitari Germans Trias i Pujol HUGTiP for the viral load analysis by RT-PCR The remaining saliva volume will be transferred to IrsiCaixas Laboratory located in the HUGTiP for the ELISA analysis and the rest of the analysis and for storage in those cases where the subjects IC is available for it
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None