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

NCT ID: NCT04563689

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-18

Study Completion Date

2020-10-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

actve

oral rinse

Group Type EXPERIMENTAL

CHX0.12+CPC0.05 oral rinse (PerioAidActive Control)

Intervention Type OTHER

rinse 15 ml during 1 min during 5 days, twice daily

placebo

distilled water,

Group Type PLACEBO_COMPARATOR

placebo rinse

Intervention Type OTHER

destilled water rinse 15 ml during 1 min during 5 days, twice daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CHX0.12+CPC0.05 oral rinse (PerioAidActive Control)

rinse 15 ml during 1 min during 5 days, twice daily

Intervention Type OTHER

placebo rinse

destilled water rinse 15 ml during 1 min during 5 days, twice daily

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dentaid SL

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ruben Leon, PhD

Role: STUDY_DIRECTOR

Dentaid SL

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Escuela odontologia. Facultad de Salud Hospital del Valle

Cali, , Colombia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Colombia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

COVID-POC1

Identifier Type: -

Identifier Source: org_study_id