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 0,07%.

Summary

Participation Requirements

Description

CPC is a monocationic molecule in nature, with a substantivity of 3 to 5 hours, soluble in alcohol and in aqueous solutions, and can act as a detergent and antiseptic. It is neither corrosive nor oxidizing and has a neutral pH. It has viricidal activity, since its mechanism of action is linked to th...

CPC is a monocationic molecule in nature, with a substantivity of 3 to 5 hours, soluble in alcohol and in aqueous solutions, and can act as a detergent and antiseptic. It is neither corrosive nor oxidizing and has a neutral pH. It has viricidal activity, since its mechanism of action is linked to the alteration of the lipid envelope, allowing the degradation of the lipid bilayer in enveloped viruses -such as respiratory syncytial virus and coronaviruses-, through physicochemical interactions, causing the breakdown and inactivation of the virus. Substantial viricidal activity is observed even at very low concentrations of CPC without development of resistance. Furthermore, the CPC in the formulation reduces the mortality and morbidity associated with the influenza virus in vivo. In 2015 the Scientific Committee on Consumer Safety (SCSS) of the European Union (SCCS / 1548/15) reviewed the CPC's toxicity, local toxicology and safety data, with safety conclusions for concentrations less than 0.1% for its oral use. Study procedures will be as follows: The study activities will take place in 1 day (total interval of 3 hours from the baseline sample collection to the last sample collection). The investigator will obtain the informed consent of subjects with a positive result of PCR or antigen test for SARS-CoV-2 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), instruct the subject in the procedure of self-collection of a saliva sample and the subject will self-collect the first saliva sample in front of the investigator, who will be able to correct the errors observed in the self-take. Hour 0: 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 refrain from brushing their teeth, eating and drinking, except water, and may return home. Hour 1: One hour after mouthwash use, the subject will self-collect the second saliva sample. The subject must refrain from brushing teeth, eating and drinking, except water, until the third sample is collected at 3 hours. Hour 3: Three hours after the use of the mouthwash, the subject will self-collect the third saliva sample.

Tracking Information