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

Covid19 Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04563689
• Other study ID #: COVID-POC1
• Status: Completed
• Phase: N/A
• Start date: June 18, 2020
• Est. completion date: October 23, 2020

Study information

• Verified date: September 2020
• Source: Dentaid SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 23, 2020
• Est. primary completion date: October 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

Other:
• CHX0.12+CPC0.05 oral rinse (PerioAidActive Control)
rinse 15 ml during 1 min during 5 days, twice daily
• placebo rinse
destilled water rinse 15 ml during 1 min during 5 days, twice daily

Locations

Country	Name	City	State
Colombia	Escuela odontologia. Facultad de Salud Hospital del Valle	Cali

Sponsors (1)

Lead Sponsor	Collaborator
Dentaid SL

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	number of patients with adverse events during 5 days study duration	description of adverse events	through study completion in day 5