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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05049213

Collaborator

(none)

Enrollment

Location

Arm

15.2

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 SARS-CoV 2 Infection	Drug: Carrageenan nasal spray and 1% PVP- mouthwash and gargle	Phase 4

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

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 24, 2022

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

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 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

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 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

Outcome Measures

Primary Outcome Measures

Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day 8 [7 days]
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 [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)
frequency of adverse effects of interest after anti-septic [10 days]
including nasal discomfort, sneezing, epistaxis, headache and otalgia
number of days in an ICU [up to 14 days]
number of days in an ICU
number of days Non Invasive Ventilation (NIV) was required during hospitalization [up to 14 days]
NIV usage during hospitalization
mortality rates [up to 30 days]
mortality rates
length of hospitalization [up to 14 days]
length of hospitalization
days of discharge [up to 30 days]
free from quarantine

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)