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

Dentaid SL23 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Covid19

Interventions

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

rinse 15 ml during 1 min during 5 days, twice daily

placebo rinseOTHER

destilled water rinse 15 ml during 1 min during 5 days, twice daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Escuela odontologia. Facultad de Salud Hospital del Valle

Cali, Colombia

Outcomes

Primary Outcomes

exploratory change in viral load

change versus baseline in viral load of SARS-CoV-2 in spontaneous saliva measured by quantitative PCR

Time frame: baseline (pre-rinse) and 15 min, 1 hour, 2 hours and 5 days after initial oral rinse

Secondary Outcomes

number of patients who have decrease in viral load of SARS-CoV-2 in spontaneous saliva measured by quantitative PCR

Time frame: 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

Time frame: through study completion in day 5

Data from ClinicalTrials.gov

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