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

Phase 4

Completed

• Conditions: Covid19; SARS-CoV 2 Infection
• Interventions: Drug: Carrageenan nasal spray and 1% PVP- mouthwash and gargle

• Registration Number: NCT05049213
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-20
• Study Start: 2022-06-24
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-08-13
• Last Update Posted: 2023-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Topical medical treatment	Carrageenan nasal spray and 1% PVP- mouthwash and gargle	Intranasal spray and oral gargling

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
length of hospitalization	up to 14 days	length of hospitalization
days of discharge	up to 30 days	free from quarantine
number of days in an ICU	up to 14 days	number of days in an ICU
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 Non Invasive Ventilation (NIV) was required during hospitalization	up to 14 days	NIV usage during hospitalization
mortality rates	up to 30 days	mortality rates

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan