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.

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 Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: CHX0.12+CPC0.05 oral rinse (PerioAidActive Control); Other: placebo rinse

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Cali, Colombia, 25360
    • Escuela odontologia. Facultad de Salud Hospital del Valle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dentaid SL
• Investigators: Study Director: Ruben Leon, PhD, Dentaid SL

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2020
• Primary Completion (Actual): October 22, 2020
• Study Completion (Actual): October 23, 2020

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: COVID-POC1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No