SINUS WASH Pilot Study in Adults Testing Positive for COVID-19

Can a Sinus Rinse and Mouth Wash Reduce Viral Load in COVID-19 Positive Individuals and Their Co-residents?

COVID-19 is highly infectious and transmission of the virus is thought to be similar to that of influenza which can be transferred through droplets released when a person coughs, sneezes or talks. Studies have shown that nasal rinsing and mouth washes may be an important way to deliver treatments that could reduce the amount of a virus that is present in the nose and mouth. This also could mean that there is less virus available to pass on to others. We want to see if the use of nose rinses and mouth washes using Povidone-Iodine will reduce the the amount of virus in the nose and throat of people who have tested positive for COVID-19 disease and also reduce the spread of infection within their household.

Study Overview

• Status: Recruiting
• Conditions: Coronavirus Infection
• Intervention / Treatment: Drug: Povidone-Iodine; Drug: Normal saline

Detailed Description

COVID-19 is highly infectious and transmission of the virus is thought to be similar to that of influenza which can be transferred through droplets released when a person coughs, sneezes or talks. Studies have shown that nasal rinsing and mouth washes may be an important way to deliver treatments that could reduce the amount of a virus that reaches other parts of the body. This also could mean that there is less virus available to pass on to others.

We want to see if the use of nasal rinsing and mouth washes will reduce the spread of infection within your household by reducing and removing the virus from your mouth and nose.

Once the participants have been recruited they will be randomly allocated to one of two groups. Each arm will have the same number of participants. The two arms will be :

1. nose rinse and mouthwash with Isotonic saline alone. This will be the control arm.
2. nose rinse and mouthwash with Povidone-Iodine taken 3 times a days for three days.

Before treatment begins, each participant will have one pre-treatment swab of the back of the nose and the back of the throat taken.

Once allocated each participant will be asked to have 4 further swabs of the mouth and nose taken on days 2,4,7 & 14.

Participants will be patients and healthcare staff who have tested positive for COVID-19. Healthcare staff who are self isolating will also asked their co-residents/family members at home to take the treatment and provide swabs in the same manner.

Participants who are patients and are admitted to hospital will be well enough to perform the nasal rinses and mouth washes as treatments and provide the same swabs.

All participants will be provided with informational videos on how to do the treatments and how to take the swabs. Participants who are not healthcare staff will have swabs taken as part of the local drive through testing service.

All participants will be asked to download a free smartphone app (Umotif) to upload information about daily symptoms and whether they have provided swabs on the required days.

The swabs will be tested for the amount of virus in the labs at Hampshire Hospitals NHS Foundation Trust and analysed to determine if the treatment arm of Povidone-Iodine is reducing the amount of virus compared to the isotonic saline arm.

All results will be anonymised prior to analysis. The study team will know the participants' study-specific data; no personal data about participants will be used without their explicit consent and only for the purposes of protocol adherence and data to answer the study question.

Once the last swab has been taken and delivered to the laboratory, the trial will have ended for that participant. Results of the swabs will be part of the study data and collated in readiness for analysis by the study statistician.

The results will be made available for peer-reviewed publication and presentation at conferences.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Afroze Khan, MBBS MRCS; Phone Number: +447885903693; Email: Afroze.Khan@nhs.net
• Study Contact Backup: Name: Matthew Dryden; Email: matthew.dryden@hhft.nhs.uk

Study Locations

• United Kingdom
  • Hampshire
    • Basingstoke, Hampshire, United Kingdom, RG24 9NA
      • Recruiting
      • Hampshire Hospitals NHS Foundation Trust
      • Contact: Afroze Khan, MBBS MRCS
      • Contact: Matthew Dryden

Participation Criteria

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:

• Healthcare worker OR patient on a general ward who has had a positive COVID-19 test OR a person who is co-residing with an affected staff member or patient who is now at home in self-isolation.
• capable of giving informed consent
• able to self-administer the sinus rinses and mouth washes
• able to have healthcare professional-led swabs OR self-administer the oral and nasopharyngeal swabs
• aged 18 years and over.

Exclusion Criteria:

• not capable of giving informed consent
• unable to self-administer the sinus rinses and mouth washes
• unable to have healthcare professional-led swabs OR self-administer the oral, nasal and/OR nasopharyngeal swabs
• unable to send swabs to the study team via the approved methods described in participant information leaflet and protocol
• under 18 years of age.
• known hypersensitivity to Iodine
• at risk of aspiration due to an unsafe swallow
• hyperthyroidism or other manifest thyroid diseases
• herpetiform dermatitis (Duhring's disease)
• planned or undergoing radioiodine treatment
• actively Breastfeeding
• pregnant

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Povidone-Iodine; 0.23% sinus rinse and mouthwash three times daily (tds) for days 1-3 of study	Drug: Povidone-Iodine; 0.23% three times daily (tds) for 3 days; Other Names: Videne Antiseptic Solution
Placebo Comparator: Normal Saline; sinus rinse and mouthwash three times daily (tds) for days 1-3 of study	Drug: Normal saline; 0.9% three times daily (tds) for 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in viral load in the oral and nasopharyngeal cavity	viral load as measured by real time polymerase chain reaction (PCR)	Day 0, 2, 3, 7, 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom severity in primary participants and co-residents	Visual analogue score 1-5 per symptom via a smartphone app	Days 0 to 14

Collaborators and Investigators

• Sponsor: Hampshire Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Afroze Khan, MBBS MRCS, Hampshire Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2020
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; coronavirus; povidone-iodine; sinus rinse; mouth wash; Wuhan
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections; Anti-Infective Agents, Local; Anti-Infective Agents; Plasma Substitutes; Blood Substitutes; Povidone-Iodine; Povidone
• Other Study ID Numbers: SPON-AK-0420; 2020-001721-31 (EudraCT Number)

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
• product manufactured in and exported from the U.S.: No