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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04563689

Enrollment

Registered

2020-09-24

Start date

2020-06-18

Completion date

2020-10-23

Last updated

2020-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Brief summary

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

Interventions

OTHERCHX0.12+CPC0.05 oral rinse (PerioAidActive Control)

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

OTHERplacebo rinse

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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 who have decrease in viral load of SARS-CoV-2 in spontaneous saliva measured by quantitative PCR
number of patients with adverse events during 5 days study duration	through study completion in day 5	description of adverse events

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026