Effect of Local Treatment(Carrageenan Nasal Spray and PVP-I Mouthwash) in Reducing Viral Load in Patients With COVID-19 (LT-COVID19)
Primary Purpose
Covid19, SARS-CoV 2 Infection
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Carrageenan nasal spray and 1% PVP- mouthwash and gargle
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring COVID-19, Anti-septic, Carrageenan, Nasal spray, Povidone-Iodine(PVP-I), Gargle, Mouthwash
Eligibility Criteria
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
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Topical medical treatment
Arm Description
Intranasal spray and oral gargling
Outcomes
Primary Outcome Measures
Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day 8
the mean change of viral titers of COVID-19 between Day 1 and Day 8 by RT-PCR test
Secondary Outcome Measures
symptoms related to COVID-19
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)
frequency of adverse effects of interest after anti-septic
including nasal discomfort, sneezing, epistaxis, headache and otalgia
number of days in an ICU
number of days in an ICU
number of days Non Invasive Ventilation (NIV) was required during hospitalization
NIV usage during hospitalization
mortality rates
mortality rates
length of hospitalization
length of hospitalization
days of discharge
free from quarantine
Full Information
NCT ID
NCT05049213
First Posted
September 16, 2021
Last Updated
August 13, 2023
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05049213
Brief Title
Effect of Local Treatment(Carrageenan Nasal Spray and PVP-I Mouthwash) in Reducing Viral Load in Patients With COVID-19
Acronym
LT-COVID19
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 24, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, SARS-CoV 2 Infection
Keywords
COVID-19, Anti-septic, Carrageenan, Nasal spray, Povidone-Iodine(PVP-I), Gargle, Mouthwash
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topical medical treatment
Arm Type
Experimental
Arm Description
Intranasal spray and oral gargling
Intervention Type
Drug
Intervention Name(s)
Carrageenan nasal spray and 1% PVP- mouthwash and gargle
Other Intervention Name(s)
BETADINE™ Cold Defense Nasal Spray and Povidone Iodine Mouthwash and Gargle
Intervention Description
Day1 to Day7
Intranasal spray 3 times/day, 2~3 spray/nostril/per time
Oral gargling 3 times/day, 15cc/per time
Primary Outcome Measure Information:
Title
Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day 8
Description
the mean change of viral titers of COVID-19 between Day 1 and Day 8 by RT-PCR test
Time Frame
7 days
Secondary Outcome Measure Information:
Title
symptoms related to COVID-19
Description
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)
Time Frame
10 days
Title
frequency of adverse effects of interest after anti-septic
Description
including nasal discomfort, sneezing, epistaxis, headache and otalgia
Time Frame
10 days
Title
number of days in an ICU
Description
number of days in an ICU
Time Frame
up to 14 days
Title
number of days Non Invasive Ventilation (NIV) was required during hospitalization
Description
NIV usage during hospitalization
Time Frame
up to 14 days
Title
mortality rates
Description
mortality rates
Time Frame
up to 30 days
Title
length of hospitalization
Description
length of hospitalization
Time Frame
up to 14 days
Title
days of discharge
Description
free from quarantine
Time Frame
up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Te-Huei Yeh, MD-PhD
Organizational Affiliation
National Taiwan University Hospital, Department of Otolaryngology
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
no plan to share individual participant data (IPD)
Citations:
PubMed Identifier
33538761
Citation
Guenezan J, Garcia M, Strasters D, Jousselin C, Leveque N, Frasca D, Mimoz O. Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Nasopharyngeal Viral Load in Patients With COVID-19: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Apr 1;147(4):400-401. doi: 10.1001/jamaoto.2020.5490.
Results Reference
result
PubMed Identifier
34044151
Citation
Carrouel F, Valette M, Gadea E, Esparcieux A, Illes G, Langlois ME, Perrier H, Dussart C, Tramini P, Ribaud M, Bouscambert-Duchamp M, Bourgeois D. Use of an antiviral mouthwash as a barrier measure in the SARS-CoV-2 transmission in adults with asymptomatic to mild COVID-19: a multicentre, randomized, double-blind controlled trial. Clin Microbiol Infect. 2021 Oct;27(10):1494-1501. doi: 10.1016/j.cmi.2021.05.028. Epub 2021 May 24.
Results Reference
result
PubMed Identifier
33397432
Citation
Hasan MJ, Rumi SKNF, Banu SS, Uddin AKMN, Islam MS, Arefin MK. Virucidal effect of povidone iodine on COVID-19 in the nasopharynx: A structured summary of a study protocol for an open-label randomized clinical trial. Trials. 2021 Jan 4;22(1):2. doi: 10.1186/s13063-020-04963-2.
Results Reference
result
Learn more about this trial
Effect of Local Treatment(Carrageenan Nasal Spray and PVP-I Mouthwash) in Reducing Viral Load in Patients With COVID-19
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