Pilot Study to Evaluate Effect of CHX0.12/CPC 0.05 of SARS-CoV-2 Viral Load in COVID-19 Patients

Dentaid

Status: Completed

Conditions: Covid19

Treatments: Other: placebo rinse; Other: CHX0.12+CPC0.05 oral rinse (PerioAidActive Control)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04563689

COVID-POC1

Details and patient eligibility

About

Randomized, double-blind, placebo-controlled pilot study to evalaute viral load in saliva of COVID19+ patients using quantitative PCR, before and after use of active or placebo rinses

Enrollment: 23 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Be positive for SARS-CoCV-2 real-time PCR test
2. SARS-CoV-2 patients positive, with home and/or hospitalized care.
3. Have a medical condition that allows them to perform a mouthwash for 1 minute.

Exclusion criteria

1. Pregnant.
2. People with impaired lung function who do not allow them to rinse.
3. Patients with antiviral treatment for Covid-19.
4. Patients with diseases that affect saliva, Sjogren's syndrome, and Systemic Lupus Erythematosus.
5. Any cause of immunosuppression (primary or secondary), including HIV.
6. Chronic kidney disease 3b or older, Coronary heart disease, Uncontrolled diabetes (Hb1Ac >7), Uncontrolled high blood pressure, Uncontrolled thyroid disease, history of cancer less than 1 year

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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23 participants in 2 patient groups, including a placebo group

actve

Experimental group

Description:

oral rinse

Treatment:

Other: CHX0.12+CPC0.05 oral rinse (PerioAidActive Control)

placebo

Placebo Comparator group

Description:

distilled water,

Treatment:

Other: placebo rinse