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Completed

NCT Number: NCT05049213

Effect of Local Treatment(Carrageenan Nasal Spray and PVP-I Mouthwash) in Reducing Viral Load in Patients With COVID-19

The goal of this study is to recruit confirmed Covid-19 patients, to evaluate whether the topical anti-septic can improve clinical outcome in early Severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) infection. During the global pandemic period, an effective and highly available method once be identified, it will reduce the risk of disease transmission and lower the medical burden.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

Oral and nasal disinfection, a simple method with the application of commonly used antiseptic agents is frequently performed in the otolaryngology and dental practice. The ability to deactivate viral particles with a good safety profile may be an important benefit in the control of viral proliferation and shedding. Actually, multiple anti-septic agents demonstrated virucidal properties against SARS-CoV-2 in several in vitro studies. Among these, Povidone-Iodine (PVP-I), common usage in otolaryngology operation and topical therapy, showed high virucidal properties (0.45% PVP-I, throat spray, 4-log drop in viral load) and of great safety. There is also evidence that topical usage of saline can decrease the severity of upper respiratory tract infection. In addition, carrageenan, a sulphated polysaccharide purified from red marine algae, had shown efficacy in inhibiting multiple viruses, including in vitro studies of SARS-CoV-2. Some randomized controlled trials had also shown their abilities in improving patients' symptoms with a good safety profile. Multiple international organizations are conducting relating randomized clinical trials to evaluate whether the topical anti-septic improves clinical outcomes after early SARS-CoV-2 infection. The added value of topical antiseptic agents may be beneficial in improving symptoms, reducing viral load and alleviating the rate of disease progression. Due to relatively low risk, well-toleration to the general population, and highly available characteristics, the potential benefits of these agents deserve more attention.

The goal of this study is to investigate the changes in clinical symptoms and sequential laboratory data in confirmed COVID-19 adult patients at the early disease stage. By applying topical anti-septic which is frequently used in otolaryngology procedures, the investigators will evaluate the impact of this intervention on the symptoms, viral load and the rate of disease progression. During the global pandemic period, an effective and highly available method once be identified, it will reduce the risk of disease transmission and lower the medical burden.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age older than 20 years of age
  • admission with a confirmed positive test for SARS-CoV-2 infection by reverse transcription polymerase chain reaction (RT- PCR)
  • disease onset (start of COVID-19 symptom and PCR test) for ≤ 120 hours
  • available informed consent of this study.
  • Full COVID-19 vaccination(at least after 2nd dose of TFDA-approved vaccine 14 days)

Exclusion criteria

  • receiving oxygen supply before intervention
  • known intolerance/allergy to the study drugs
  • pregnancy
  • sinus/oral operation within 30 days of the beginning of the study
  • using intranasal medication before randomization
  • no available informed consent
  • inability to self-care or reply to questionnaire

Treatment and study plan

Carrageenan nasal spray and 1% PVP- mouthwash and gargle

Drug

Day1 to Day7

  • Intranasal spray 3 times/day, 2~3 spray/nostril/per time
  • Oral gargling 3 times/day, 15cc/per time

Other names: BETADINE™ Cold Defense Nasal Spray and Povidone Iodine Mouthwash and Gargle

Primary outcomes

  1. Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day 8

    Time frame: 7 days

    the mean change of viral titers of COVID-19 between Day 1 and Day 8 by RT-PCR test

Secondary outcomes

  1. symptoms related to COVID-19

    Time frame: 10 days

    including cough, fatigue, shortness of breath, loss of smell, hoarseness, chest pain, abdominal pain, diarrhea, headache, sore throat, muscle pain, etc and Quality of Life using the validated SinoNasal Outcome Tool-22 (SNOT-22, total score range 0-110, higher scores represent worse symptoms)

  2. frequency of adverse effects of interest after anti-septic

    Time frame: 10 days

    including nasal discomfort, sneezing, epistaxis, headache and otalgia

  3. number of days in an ICU

    Time frame: up to 14 days

    number of days in an ICU

  4. number of days Non Invasive Ventilation (NIV) was required during hospitalization

    Time frame: up to 14 days

    NIV usage during hospitalization

  5. mortality rates

    Time frame: up to 30 days

    mortality rates

  6. length of hospitalization

    Time frame: up to 14 days

    length of hospitalization

  7. days of discharge

    Time frame: up to 30 days

    free from quarantine

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Investigating the Therapeutic Role of Topical Medical Treatment in Oral and Nasal Cavities on the Patients With Positive Severe Cute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection

Acronym: LT-COVID19

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 20, 2021
Registry last updated
Aug 15, 2023

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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