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

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Other: placebo rinse; Other: CHX0.12+CPC0.05 oral rinse (PerioAidActive Control)

• Registration Number: NCT04563689
• Lead Sponsor: Dentaid SL

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-18
• Status Verified: 2020-09
• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-24
• Primary Completion: 2020-10-22
• Study Completion: 2020-10-23
• Last Update Submitted: 2020-11-19
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo rinse	distilled water,
actve	CHX0.12+CPC0.05 oral rinse (PerioAidActive Control)	oral rinse

Primary Outcome Measures

Name	Time	Method
exploratory change in viral load	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

Secondary Outcome Measures

Name	Time	Method
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 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	through study completion in day 5	description of adverse events

Trial Locations

Locations (1)

Escuela odontologia. Facultad de Salud Hospital del Valle; 🇨🇴 Cali, Colombia