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

2019 Novel Coronavirus Infection Clinical Trial

Official title: 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)

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• 2019 Novel Coronavirus Infection
• Coronavirus Infections
• COVID-19

• NCT number: NCT05375773
• Study type: Interventional
• Source: Ruijin Hospital
• Contact: Meiqin Xue
• Phone: 18917762673
• Email: xmq21966@rjh.com.cn
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2022
• Completion date: October 31, 2022