Effect of Local Treatment(Carrageenan Nasal Spray and PVP-I Mouthwash) in Reducing Viral Load in Patients With COVID-19 (LT-COVID19)

August 13, 2023 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Topical medical treatment
Intranasal spray and oral gargling
Drug: Carrageenan nasal spray and 1% PVP- mouthwash and gargle

Day1 to Day7

  1. Intranasal spray 3 times/day, 2~3 spray/nostril/per time
  2. Oral gargling 3 times/day, 15cc/per time
Other Names:
  • BETADINE™ Cold Defense Nasal Spray and Povidone Iodine Mouthwash and Gargle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
10 days
frequency of adverse effects of interest after anti-septic
Time Frame: 10 days
including nasal discomfort, sneezing, epistaxis, headache and otalgia
10 days
number of days in an ICU
Time Frame: up to 14 days
number of days in an ICU
up to 14 days
number of days Non Invasive Ventilation (NIV) was required during hospitalization
Time Frame: up to 14 days
NIV usage during hospitalization
up to 14 days
mortality rates
Time Frame: up to 30 days
mortality rates
up to 30 days
length of hospitalization
Time Frame: up to 14 days
length of hospitalization
up to 14 days
days of discharge
Time Frame: up to 30 days
free from quarantine
up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Te-Huei Yeh, MD-PhD, National Taiwan University Hospital, Department of Otolaryngology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2022

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

September 16, 2021

First Submitted That Met QC Criteria

September 16, 2021

First Posted (Actual)

September 20, 2021

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202106183RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan to share individual participant data (IPD)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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