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

NCT04393792 | Unknown Phase 1

• 2 other identifiers: SPON-AK-04202020-001721-31
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronavirus Infection

Keywords

COVID-19; sinus rinse; mouth wash; povidone-iodine; coronavirus; Wuhan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Symptom severity in primary participants and co-residents

  Days 0 to 14

Study Arms (2)

Povidone-Iodine

ACTIVE COMPARATOR

0.23% sinus rinse and mouthwash three times daily (tds) for days 1-3 of study

Drug: Povidone-Iodine

Normal Saline

PLACEBO COMPARATOR

sinus rinse and mouthwash three times daily (tds) for days 1-3 of study

Drug: Normal saline

Interventions

Povidone-Iodine DRUG

0.23% three times daily (tds) for 3 days

Also known as: Videne Antiseptic Solution

Povidone-Iodine

Normal saline DRUG

0.9% three times daily (tds) for 3 days

Normal Saline

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hampshire Hospitals NHS Foundation Trust: lead

Study Sites (1)

Hampshire Hospitals NHS Foundation Trust

Basingstoke, Hampshire, RG24 9NA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

Povidone-Iodine; Saline Solution

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Afroze Khan, MBBS MRCS

  Hampshire Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Afroze Khan, MBBS MRCS

CONTACT

+447885903693; Afroze.Khan@nhs.net

Matthew Dryden

CONTACT

matthew.dryden@hhft.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: unblinded parallel group design with 1:1 randomised allocation to treatment or control

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 19, 2020
• Study Start: May 5, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)