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.
1 other identifier
interventional
23
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable covid19
Started Jun 2020
Shorter than P25 for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 18, 2020
CompletedFirst Submitted
Initial submission to the registry
September 22, 2020
CompletedFirst Posted
Study publicly available on registry
September 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2020
CompletedNovember 20, 2020
September 1, 2020
4 months
September 22, 2020
November 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (2)
actve
EXPERIMENTALoral rinse
placebo
PLACEBO COMPARATORdistilled water,
Interventions
rinse 15 ml during 1 min during 5 days, twice daily
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dentaid SLlead
Study Sites (1)
Escuela odontologia. Facultad de Salud Hospital del Valle
Cali, 25360, Colombia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ruben Leon, PhD
Dentaid SL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2020
First Posted
September 24, 2020
Study Start
June 18, 2020
Primary Completion
October 22, 2020
Study Completion
October 23, 2020
Last Updated
November 20, 2020
Record last verified: 2020-09