NCT05049213

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19
• SARS-CoV 2 Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-06-24
• Primary completion: 2022-08-01
• Completion: 2022-08-01
• First posted: 2021-09-20
• Last updated: 2023-08-15

Locations

1 site across 1 country: Taiwan