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OpenTrials
Completed

NCT Number: NCT04563689

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

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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Escuela odontologia. Facultad de Salud Hospital del Valle

Cali, 25360, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

placebo rinse

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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 who have decrease in viral load of SARS-CoV-2 in spontaneous saliva measured by quantitative PCR

  2. number of patients with adverse events during 5 days study duration

    Time frame: through study completion in day 5

    description of adverse events

Sponsors and collaborators

Lead sponsor

Dentaid SL

Industry

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 24, 2020
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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