Povidone Iodine Nasal Irrigation and Gargling to Reduce Viral Load in Asymptomatic Patients With COVID-19

NCT05375773 | Unknown

• 1 other identifier: xmq21966
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The emergence of a novel coronavirus(SARS-CoV-2) in late 2019 has resulted in a global epidemic of the infectious condition COVID-19. Since March 2022, the Omicron mutant has caused widespread transmission in Shanghai, China, and is characterized by the majority of asymptomatic patients. Although showing no obvious symptoms, the asymptomatic patients have high transmissibility because of high viral loads in their oropharynx and nasopharynx. Therefore，this study puts forwards the hypothesis that local flushing treatment in the sino-nasal and mouth cavity can reduce the viral load to reduce their transmissibility. Nasal Irrigation and gargling is a safe and commonly used mechanism to treat a variety of sinonasal diseases including sinusitis, rhinitis, and upper respiratory tract infections. Povidone-iodine(PVP-I) is a water-soluble complex of povidone, a carrier molecule, and iodine, which has powerful microbicidal activity. Also, recent evidence of in-vitro virucidal action of povidone-iodine in Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS CoV-2) has been supported. Therefore, the study is designed to assess the virucidal effect of nasal irrigation and gargling with PVP-I against SARS-CoV-2 located in the throat. The hypothesis was that the treatment would be effective in improving the negative conversion rate of SARS-CoV-2 nucleic acid on day 10.

Conditions

2019 Novel Coronavirus Infection

Keywords

Povidone-Iodine; Nasal Lavage and gargling

Outcome Measures

Primary Outcomes (1)

• negative conversion rate

  On the 10th day after entering the Fang Chang Hospital, the negative conversion rate of novel coronavirus nucleic acid detected by nasopharyngeal sampling. the "turning negative" is defined as the person whose nucleic acid detection is negative for two times after an interval of more than 24 hours according to the diagnosis and treatment for novel coronavirus pneumonia (Trial Nine Edition).

  the 10th day after entering the Fang Chang Hospital

Secondary Outcomes (5)

• negative conversion rate

  the 5th 、7th and 14th day after entering the Fang Chang Hospital

• the length of time for patient s when nucleic acid result turns to be negative

  1-14 days or until the nucleic acid result is negative

• Intraoral viral load

  10th day of using Nasal Irrigation and gargling

• Number of participants reporting side effects of nasal irrigation

  1-14 days or until the participant reports that they are well

• Self-reported clinical discomfort

  1-14 days or until the participant reports that they are well

Study Arms (2)

Control group

NO INTERVENTION

Participants in the Control group accept standard treatment for the management of their symptoms according to the diagnosis and treatment for novel coronavirus pneumonia (Trial Nine Edition).

PVP-I Nasal Irrigation and gargling

EXPERIMENTAL

Participants in the intervention arm will be required to perform Nasal Irrigation and gargling 4 times daily. They will also accept standard treatment for the management of their symptoms according to the diagnosis and treatment for novel coronavirus pneumonia (Trial Nine Edition).

Other: PVP-I Nasal Irrigation and gargling

Interventions

PVP-I Nasal Irrigation and gargling OTHER

The solution is prepared by the researcher, which contains 0.5% PVP-I and 2.27% hypertonic saline

PVP-I Nasal Irrigation and gargling

Eligibility Criteria

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

You may qualify if:

• Patients nucleic acid testing positive for COVID-19.
• Diagnose as asymptomatic patients infected by COVID-19, and receive medical observation at a Fang Chang Hospital.
• Be able to understand this study, willing to participate in, and sign the informed consent form.
• Commit to follow the research procedures and cooperate in the implementation of the whole process research.
• Can communicate with researchers through smart phones.

You may not qualify if:

• The nucleic acid test result of novel coronavirus has always been negative after entering the Fang Chang Hospital.
• patients who have history of nasal surgery, or current use of nasal saline irrigation or other intranasal medications.
• Patients with thyroid diseases , respiratory diseases or other serious basic diseases.
• Allergy to iodine.
• Participation in another prospective COVID related research project(clinical trial).
• Pregnancy or lactation
• Patients with immune deficiency (such as patients with malignant tumors, organ or bone marrow transplantation, patients with AIDS, and those taking immunosuppressive drugs within 3 months before screening).
• Other patients considered unsuitable by the investigator to participate in this study

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital,Shanghai Jiaotong University school of medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (11)

• Zou L, Ruan F, Huang M, Liang L, Huang H, Hong Z, Yu J, Kang M, Song Y, Xia J, Guo Q, Song T, He J, Yen HL, Peiris M, Wu J. SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients. N Engl J Med. 2020 Mar 19;382(12):1177-1179. doi: 10.1056/NEJMc2001737. Epub 2020 Feb 19. No abstract available.

  PMID: 32074444 BACKGROUND

• Koksal T, Cizmeci MN, Bozkaya D, Kanburoglu MK, Sahin S, Tas T, Yuksel CN, Tatli MM. Comparison between the use of saline and seawater for nasal obstruction in children under 2 years of age with acute upper respiratory infection. Turk J Med Sci. 2016 Jun 23;46(4):1004-13. doi: 10.3906/sag-1507-18.

  PMID: 27513397 BACKGROUND

• Slapak I, Skoupa J, Strnad P, Hornik P. Efficacy of isotonic nasal wash (seawater) in the treatment and prevention of rhinitis in children. Arch Otolaryngol Head Neck Surg. 2008 Jan;134(1):67-74. doi: 10.1001/archoto.2007.19.

  PMID: 18209140 BACKGROUND

• Ramalingam S, Graham C, Dove J, Morrice L, Sheikh A. A pilot, open labelled, randomised controlled trial of hypertonic saline nasal irrigation and gargling for the common cold. Sci Rep. 2019 Jan 31;9(1):1015. doi: 10.1038/s41598-018-37703-3.

  PMID: 30705369 BACKGROUND

• Ramalingam S, Cai B, Wong J, Twomey M, Chen R, Fu RM, Boote T, McCaughan H, Griffiths SJ, Haas JG. Antiviral innate immune response in non-myeloid cells is augmented by chloride ions via an increase in intracellular hypochlorous acid levels. Sci Rep. 2018 Sep 11;8(1):13630. doi: 10.1038/s41598-018-31936-y.

  PMID: 30206371 BACKGROUND

• Vogt PM, Hauser J, Mueller S, Bosse B, Hopp M. Efficacy of Conventional and Liposomal Povidone-Iodine in Infected Mesh Skin Grafts: An Exploratory Study. Infect Dis Ther. 2017 Dec;6(4):545-555. doi: 10.1007/s40121-017-0172-z. Epub 2017 Oct 10.

  PMID: 29019097 BACKGROUND

• Eggers M, Koburger-Janssen T, Eickmann M, Zorn J. In Vitro Bactericidal and Virucidal Efficacy of Povidone-Iodine Gargle/Mouthwash Against Respiratory and Oral Tract Pathogens. Infect Dis Ther. 2018 Jun;7(2):249-259. doi: 10.1007/s40121-018-0200-7. Epub 2018 Apr 9.

  PMID: 29633177 BACKGROUND

• Kariwa H, Fujii N, Takashima I. Inactivation of SARS coronavirus by means of povidone-iodine, physical conditions and chemical reagents. Dermatology. 2006;212 Suppl 1(Suppl 1):119-23. doi: 10.1159/000089211.

  PMID: 16490989 BACKGROUND

• Eggers M, Eickmann M, Zorn J. Rapid and Effective Virucidal Activity of Povidone-Iodine Products Against Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and Modified Vaccinia Virus Ankara (MVA). Infect Dis Ther. 2015 Dec;4(4):491-501. doi: 10.1007/s40121-015-0091-9. Epub 2015 Sep 28.

  PMID: 26416214 BACKGROUND

• Anderson DE, Sivalingam V, Kang AEZ, Ananthanarayanan A, Arumugam H, Jenkins TM, Hadjiat Y, Eggers M. Povidone-Iodine Demonstrates Rapid In Vitro Virucidal Activity Against SARS-CoV-2, The Virus Causing COVID-19 Disease. Infect Dis Ther. 2020 Sep;9(3):669-675. doi: 10.1007/s40121-020-00316-3. Epub 2020 Jul 8.

  PMID: 32643111 BACKGROUND

• Arefin MK, Rumi SKNF, Uddin AKMN, Banu SS, Khan M, Kaiser A, Chowdhury JA, Khan MAS, Hasan MJ. Virucidal effect of povidone iodine on COVID-19 in the nasopharynx: an open-label randomized clinical trial. Indian J Otolaryngol Head Neck Surg. 2022 Oct;74(Suppl 2):2963-2967. doi: 10.1007/s12070-021-02616-7. Epub 2021 May 18.

  PMID: 34026595 BACKGROUND

MeSH Terms

Conditions

COVID-19

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

Central Study Contacts

Meiqin Xue

CONTACT

18917762673; xmq21966@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical nursing professor

Study Record Dates

• First Submitted: May 15, 2022
• First Posted: May 17, 2022
• Study Start: April 16, 2022
• Primary Completion: August 31, 2022
• Study Completion: October 31, 2022
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)