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

Covid19 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05049213
• Other study ID #: 202106183RIND
• Status: Completed
• Phase: Phase 4
• Start date: June 24, 2022
• Est. completion date: August 1, 2022

Study information

• Verified date: July 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Infections
• SARS-CoV 2 Infection

Intervention

Drug:
• Carrageenan nasal spray and 1% PVP- 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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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 asymptomati — View 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. 2 — View 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: 10.11 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 days
Secondary	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)	10 days
Secondary	frequency of adverse effects of interest after anti-septic	including nasal discomfort, sneezing, epistaxis, headache and otalgia	10 days
Secondary	number of days in an ICU	number of days in an ICU	up to 14 days
Secondary	number of days Non Invasive Ventilation (NIV) was required during hospitalization	NIV usage during hospitalization	up to 14 days
Secondary	mortality rates	mortality rates	up to 30 days
Secondary	length of hospitalization	length of hospitalization	up to 14 days
Secondary	days of discharge	free from quarantine	up to 30 days