Covid19NCT04563689
Pilot Study to Evaluate Effect of CHX0.12/CPC 0.05 of SARS-CoV-2 Viral Load in COVID-19 Patients
A study of Covid19, run by Dentaid SL at 1 site in Colombia.
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 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Covid19
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteColombia
- Study dates
- 18 Jun 2020to 23 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Escuela odontologia. Facultad de Salud Hospital del Valle
Cali, 25360
About this study
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.
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
- Conditions
- Covid19
- Being tested
- CHX0.12+CPC0.05 oral rinse (PerioAidActive Control), placebo rinse
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHX0.12+CPC0.05 oral rinse (PerioAidActive Control)Other
rinse 15 ml during 1 min during 5 days, twice daily
placebo rinseOther
destilled water rinse 15 ml during 1 min during 5 days, twice daily
| Study group | Role | What they receive |
|---|---|---|
| actve | Experimental | oral rinse Receives: Other: CHX0.12+CPC0.05 oral rinse (PerioAidActive Control) |
| placebo | Placebo comparator | distilled water, Receives: Other: placebo rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
exploratory change in viral load
change versus baseline in viral load of SARS-CoV-2 in spontaneous saliva measured by quantitative PCR
Measured: 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
number of patients who have decrease in viral load of SARS-CoV-2 in spontaneous saliva measured by quantitative PCR
Measured: 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
Measured: through study completion in day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start18 Jun 2020
- Primary completion22 Oct 2020
- Study completion23 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentaid SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruben Leon, PhD, Study director, Dentaid SL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563689
- Sponsor's protocol ID
- COVID-POC1
- Status last verified
- Sep 2020
- First submitted
- 22 Sep 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04563689
- Acronym / sponsor ID
- COVID-POC1
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Dentaid SLIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 22 Oct 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| actve | Experimental | Other: CHX0.12+CPC0.05 oral rinse (PerioAidActive Control)oral rinse |
| placebo | Placebo comparator | Other: placebo rinsedistilled water, |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHX0.12+CPC0.05 oral rinse (PerioAidActive Control)rinse 15 ml during 1 min during 5 days, twice daily | Other | actve |
| placebo rinsedestilled water rinse 15 ml during 1 min during 5 days, twice daily | Other | placebo |
Primary outcome
exploratory change in viral load
Time frame: baseline (pre-rinse) and 15 min, 1 hour, 2 hours and 5 days after initial oral rinse
change versus baseline in viral load of SARS-CoV-2 in spontaneous saliva measured by quantitative PCR
2 secondary outcomes
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
number of patients with adverse events during 5 days study duration
Time frame: through study completion in day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruben Leon, PhD study director
Dentaid SL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Covid19, run by Dentaid SL at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exploratory change in viral load (time frame: baseline (pre-rinse) and 15 min, 1 hour, 2 hours and 5 days after initial oral rinse). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.