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

NCT05049213 | Completed Phase 4

• 1 other identifier: 202106183RIND
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; SARS-CoV 2 Infection

Keywords

COVID-19; Anti-septic; Carrageenan; Nasal spray; Povidone-Iodine(PVP-I); Gargle; Mouthwash

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• symptoms related to COVID-19

  10 days

• frequency of adverse effects of interest after anti-septic

  10 days

• number of days in an ICU

  up to 14 days

• number of days Non Invasive Ventilation (NIV) was required during hospitalization

  up to 14 days

• mortality rates

  up to 30 days

Study Arms (1)

Topical medical treatment

EXPERIMENTAL

Intranasal spray and oral gargling

Drug: Carrageenan nasal spray and 1% PVP- mouthwash and gargle

Interventions

Carrageenan nasal spray and 1% PVP- mouthwash and gargle DRUG

Day1 to Day7 1. Intranasal spray 3 times/day, 2\~3 spray/nostril/per time 2. Oral gargling 3 times/day, 15cc/per time

Also known as: BETADINE™ Cold Defense Nasal Spray and Povidone Iodine Mouthwash and Gargle

Topical medical treatment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 33538761 RESULT

• 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 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.

  PMID: 34044151 RESULT

• 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: 10.1186/s13063-020-04963-2.

  PMID: 33397432 RESULT

MeSH Terms

Conditions

COVID-19

Interventions

Mouthwashes

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Te-Huei Yeh, MD-PhD

  National Taiwan University Hospital, Department of Otolaryngology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 20, 2021
• Study Start: June 24, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 15, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)