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

May 17, 2022 updated by: WU Beiwen, Ruijin Hospital

A Single-center, Open-label, Randomized Controlled Trial to Evaluate the Efficacy of Sino-nasal and Mouth Cavity Rinse With an Iodine-based Solution in Reducing Viral Load in Asymptomatic Coronavirus Diseases (COVID-19)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of the study is to evaluate if using nasal irrigation and gargling with PVP-I and hypertonic saline solution, can improve the negative conversion rate of SARS-CoV-2 nucleic acid on day 10 and reduce the incidence rate and severity of symptoms associated with COVID-19.

The study is a prospective, single-center, open-label, randomized controlled trial. The subjects who met the inclusion criteria were stratified according to gender, and randomly divided into control group and experimental group. Both groups were treated according to the diagnosis and treatment for novel coronavirus pneumonia (Trial Nine Edition). Of them, the control group is as blank control, and the experimental group was rinsed with PVP-I containing hypertonic lotion prepared by 0.9% Normal saline（NS）, 10% sodium chloride（NaCl）, and povidone-iodine（PVP-I） gargle four times a day.

The participants in the control group and the experimental group will be required to fill in a daily record and report the main complaint of discomfort. The subjects in the experimental group are also asked to record the implementation of oral and nasal flushing every day.

The researchers are going to record the test results of novel coronavirus nucleic acid samples from the nasopharynx of all subjects in the control group and the experimental group every day.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Ruijin Hospital,Shanghai Jiaotong University school of medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
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).
Experimental: PVP-I Nasal Irrigation and gargling
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
The solution is prepared by the researcher, which contains 0.5% PVP-I and 2.27% hypertonic saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
negative conversion rate
Time Frame: the 10th day after entering the Fang Chang Hospital
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants reporting side effects of nasal irrigation
Time Frame: 1-14 days or until the participant reports that they are well
Number of participants in intervention arm reporting side effects
1-14 days or until the participant reports that they are well
negative conversion rate
Time Frame: the 5th 、7th and 14th day after entering the Fang Chang Hospital
the negative conversion rate of novel coronavirus nucleic acid detected by nasopharyngeal sampling
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
Time Frame: 1-14 days or until the nucleic acid result is negative
Number of days
1-14 days or until the nucleic acid result is negative
Intraoral viral load
Time Frame: 10th day of using Nasal Irrigation and gargling
Intraoral viral load as deciphered by Reverse transcription polymerase chain reaction (RT-PCR) testing
10th day of using Nasal Irrigation and gargling
Self-reported clinical discomfort
Time Frame: 1-14 days or until the participant reports that they are well
Number of participants reported, including headache, cough, runny nose, chest pain, fever, muscle soreness / fatigue, diarrhea / nausea / vomiting, loss of taste / smell and other symptoms
1-14 days or until the participant reports that they are well

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2022

Primary Completion (Anticipated)

August 31, 2022

Study Completion (Anticipated)

October 31, 2022

Study Registration Dates

First Submitted

May 15, 2022

First Submitted That Met QC Criteria

May 15, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • xmq21966

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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