Back to resultsPilot Study to Evaluate Effect of CHX0.12/CPC 0.05 of SARS-CoV-2 Viral Load in COVID-19 Patients
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
CHX0.12+CPC0.05 oral rinse (PerioAidActive Control)
placebo rinse
Sponsored by
About this trial
This is an interventional other trial for Covid19
Eligibility Criteria
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:
- Pregnant.
- People with impaired lung function who do not allow them to rinse.
- Patients with antiviral treatment for Covid-19.
- 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
Sites / Locations
- Escuela odontologia. Facultad de Salud Hospital del Valle
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
actve
placebo
Arm Description
oral rinse
distilled water,
Outcomes
Primary Outcome Measures
exploratory change in viral load
change versus baseline in viral load of SARS-CoV-2 in spontaneous saliva measured by quantitative PCR
Secondary Outcome Measures
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
number of patients with adverse events during 5 days study duration
description of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04563689
Brief Title
Pilot Study to Evaluate Effect of CHX0.12/CPC 0.05 of SARS-CoV-2 Viral Load in COVID-19 Patients
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 18, 2020 (Actual)
Primary Completion Date
October 22, 2020 (Actual)
Study Completion Date
October 23, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dentaid SL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
actve
Arm Type
Experimental
Arm Description
oral rinse
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
distilled water,
Intervention Type
Other
Intervention Name(s)
CHX0.12+CPC0.05 oral rinse (PerioAidActive Control)
Intervention Description
rinse 15 ml during 1 min during 5 days, twice daily
Intervention Type
Other
Intervention Name(s)
placebo rinse
Intervention Description
destilled water rinse 15 ml during 1 min during 5 days, twice daily
Primary Outcome Measure Information:
Title
exploratory change in viral load
Description
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 Outcome Measure Information:
Title
number of patients who have decrease in viral load of SARS-CoV-2 in spontaneous saliva measured by quantitative PCR
Description
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
Title
number of patients with adverse events during 5 days study duration
Description
description of adverse events
Time Frame
through study completion in day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Pregnant.
People with impaired lung function who do not allow them to rinse.
Patients with antiviral treatment for Covid-19.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruben Leon, PhD
Organizational Affiliation
Dentaid SL
Official's Role
Study Director
Facility Information:
Facility Name
Escuela odontologia. Facultad de Salud Hospital del Valle
City
Cali
ZIP/Postal Code
25360
Country
Colombia
12. IPD Sharing Statement
Learn more about this trial
Pilot Study to Evaluate Effect of CHX0.12/CPC 0.05 of SARS-CoV-2 Viral Load in COVID-19 Patients
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