Covid19Phase 4LT-COVID19NCT05049213
Effect of Local Treatment(Carrageenan Nasal Spray and PVP-I Mouthwash) in Reducing Viral Load in Patients With COVID-19
A Phase 4 study testing Carrageenan nasal spray and 1% PVP- mouthwash and gargle in people with Covid19 and SARS-CoV 2 Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Covid19, SARS-CoV 2 Infection
- What is being tested?
- Carrageenan nasal spray and 1% PVP- mouthwash and gargle
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Jun 2022to 1 Aug 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Covid19, SARS-CoV 2 Infection
- Being tested
- Carrageenan nasal spray and 1% PVP- mouthwash and gargle
- Keywords
- COVID-19, Anti-septic, Carrageenan, Nasal spray, Povidone-Iodine(PVP-I), Gargle, Mouthwash
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carrageenan nasal spray and 1% PVP- mouthwash and gargleDrug
Also called BETADINE™ Cold Defense Nasal Spray and Povidone Iodine Mouthwash and Gargle
Day1 to Day7
- Intranasal spray 3 times/day, 2~3 spray/nostril/per time
- Oral gargling 3 times/day, 15cc/per time
| Study group | Role | What they receive |
|---|---|---|
| Topical medical treatment | Experimental | Intranasal spray and oral gargling Receives: Drug: Carrageenan nasal spray and 1% PVP- mouthwash and gargle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (7)
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)
Measured: 10 days
frequency of adverse effects of interest after anti-septic
including nasal discomfort, sneezing, epistaxis, headache and otalgia
Measured: 10 days
number of days in an ICU
number of days in an ICU
Measured: up to 14 days
number of days Non Invasive Ventilation (NIV) was required during hospitalization
NIV usage during hospitalization
Measured: up to 14 days
mortality rates
mortality rates
Measured: up to 30 days
length of hospitalization
length of hospitalization
Measured: up to 14 days
days of discharge
free from quarantine
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start24 Jun 2022
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Te-Huei Yeh, MD-PhD, Principal investigator, National Taiwan University Hospital, Department of Otolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049213
- Sponsor's protocol ID
- 202106183RIND
- Acronym
- LT-COVID19
- Status last verified
- Jul 2023
- First submitted
- 16 Sep 2021
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share individual participant data (IPD)
Publications
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.
PubMed 33538761Carrouel 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.
PubMed 34044151Hasan 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.
PubMed 33397432
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05049213
- Acronym / sponsor ID
- LT-COVID19 / 202106183RIND
- Conditions
- Covid19, SARS-CoV 2 Infection
- Keywords
- COVID-19, Anti-septic, Carrageenan, Nasal spray, Povidone-Iodine(PVP-I), Gargle, Mouthwash
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 24 Jun 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topical medical treatment | Experimental | Drug: Carrageenan nasal spray and 1% PVP- mouthwash and gargleIntranasal spray and oral gargling |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carrageenan nasal spray and 1% PVP- mouthwash and gargleAlso: BETADINE™ Cold Defense Nasal Spray and Povidone Iodine Mouthwash and GargleDay1 to Day7 1. Intranasal spray 3 times/day, 2~3 spray/nostril/per time 2. Oral gargling 3 times/day, 15cc/per time | Drug | Topical medical treatment |
Primary outcome
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 secondary outcomes
symptoms related to COVID-19
Time frame: 10 days
frequency of adverse effects of interest after anti-septic
Time frame: 10 days
number of days in an ICU
Time frame: up to 14 days
number of days Non Invasive Ventilation (NIV) was required during hospitalization
Time frame: up to 14 days
mortality rates
Time frame: up to 30 days
length of hospitalization
Time frame: up to 14 days
days of discharge
Time frame: up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Results publication: PubMed 33538761Guenezan 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 publication: PubMed 34044151Carrouel 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 publication: PubMed 33397432Hasan 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.
- Individual participant dataSharing planned: No. no plan to share individual participant data (IPD)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Te-Huei Yeh, MD-PhD principal investigator
National Taiwan University Hospital, Department of Otolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carrageenan nasal spray and 1% PVP- mouthwash and gargle in people with Covid19 and SARS-CoV 2 Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day 8 (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05049213, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.