Clinical trial NCT05049213: Effect of Local Treatment(Carrageenan Nasal Spray and PVP-I Mouthwash) in Reducing Viral Load in Patients With COVID-19
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Covid19
SARS-CoV 2 Infection
Keywords: COVID-19
Anti-septic
Carrageenan
Nasal spray
Povidone-Iodine(PVP-I)
Gargle
Mouthwash
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline naso-pharyngeal viral load quantified by RT-PCR at Day 8
timeFrame: 7 days
Secondary outcomes:
measure: symptoms related to COVID-19
timeFrame: 10 days
measure: frequency of adverse effects of interest after anti-septic
timeFrame: 10 days
measure: number of days in an ICU
timeFrame: up to 14 days
measure: number of days Non Invasive Ventilation (NIV) was required during hospitalization
timeFrame: up to 14 days
measure: mortality rates
timeFrame: up to 30 days
measure: length of hospitalization
timeFrame: up to 14 days
measure: days of discharge
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital, Department of Otolaryngology
name: Te-Huei Yeh, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. 2021 Apr 1;147(4):400-401. doi: 10.1001/jamaoto.2020.5490.
citation: 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.
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: 10.1186/s13063-020-04963-2.