NCT04563689CompletedNot Applicable
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
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dentaid SL
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- exploratory change in viral load
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •People with impaired lung function who do not allow them to rinse.
- •Patients with antiviral treatment for Covid-
- •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
Arms & Interventions
actve
Experimental
oral rinse
Intervention: CHX0.12+CPC0.05 oral rinse (PerioAidActive Control) (Other)
placebo
Placebo Comparator
distilled water,
Intervention: placebo rinse (Other)
Outcomes
Primary Outcomes
exploratory change in viral load
Time Frame: 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 Outcomes
- 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(through study completion in day 5)
Investigators
Study Sites (1)
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