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

Study Overview
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Brief Summary
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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

Official Title
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Efecto de un Enjuague Bucal Con Clorhexidina al 0.12% y Cloruro de Cetil Piridinio al 0.05% en la Carga Viral en Saliva en Pacientes COVID-19 + Hospitalizados o Que Esten Recibiendo Cuidado médico en Casa en Cali - 2020.

Conditions
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Covid19

Intervention / Treatment
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* Other: CHX0.12+CPC0.05 oral rinse (PerioAidActive Control)
* Other: placebo rinse


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be positive for SARS-CoCV-2 real-time PCR test SARS-CoV-2 patients positive, with home and/or hospitalized care. Have a medical condition that allows them to perform a mouthwash for 1 minute. Exclusion Criteria: Pregnant. People with impaired lung function who do not allow them to rinse. Patients with antiviral treatment for Covid-19. Patients with diseases that affect saliva, Sjogren's syndrome, and Systemic Lupus Erythematosus. Any cause of immunosuppression (primary or secondary), including HIV. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: actve<br>oral rinse | Other: CHX0.12+CPC0.05 oral rinse (PerioAidActive Control)<br>* rinse 15 ml during 1 min during 5 days, twice daily<br>|
| Placebo Comparator: placebo<br>distilled water, | Other: placebo rinse<br>* destilled water rinse 15 ml during 1 min during 5 days, twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exploratory change in viral load | change versus baseline in viral load of SARS-CoV-2 in spontaneous saliva measured by quantitative PCR | baseline (pre-rinse) and 15 min, 1 hour, 2 hours and 5 days after initial oral rinse | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients who have decrease in viral load of SARS-CoV-2 in spontaneous saliva measured by quantitative PCR | number of patients who have decrease in viral load of SARS-CoV-2 in spontaneous saliva measured by quantitative PCR | 15 min, 1 hour, 2 hours and 5 days after initial oral rinse | 
| number of patients with adverse events during 5 days study duration | description of adverse events | through study completion in day 5 |