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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04393792
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : September 17, 2021
Sponsor:
Information provided by (Responsible Party):
Hampshire Hospitals NHS Foundation Trust

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronavirus Infection Drug: Povidone-Iodine Drug: Normal saline Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: unblinded parallel group design with 1:1 randomised allocation to treatment or control
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Can a Sinus Rinse and Mouth Wash Reduce Viral Load in COVID-19 Positive Individuals and Their Co-residents?
Actual Study Start Date : May 5, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. Change in viral load in the oral and nasopharyngeal cavity [ Time Frame: Day 0, 2, 3, 7, 14 ]
    viral load as measured by real time polymerase chain reaction (PCR)


Secondary Outcome Measures :
  1. Symptom severity in primary participants and co-residents [ Time Frame: Days 0 to 14 ]
    Visual analogue score 1-5 per symptom via a smartphone app


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393792


Contacts
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Contact: Afroze Khan, MBBS MRCS +447885903693 Afroze.Khan@nhs.net
Contact: Matthew Dryden matthew.dryden@hhft.nhs.uk

Locations
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United Kingdom
Hampshire Hospitals NHS Foundation Trust Recruiting
Basingstoke, Hampshire, United Kingdom, RG24 9NA
Contact: Afroze Khan, MBBS MRCS         
Contact: Matthew Dryden         
Sponsors and Collaborators
Hampshire Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Afroze Khan, MBBS MRCS Hampshire Hospitals NHS Foundation Trust
More Information
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Responsible Party: Hampshire Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04393792    
Other Study ID Numbers: SPON-AK-0420
2020-001721-31 ( EudraCT Number )
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Hampshire Hospitals NHS Foundation Trust:
COVID-19
sinus rinse
mouth wash
 povidone-iodine
coronavirus
Wuhan
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Povidone-Iodine
Povidone
Plasma Substitutes
Blood Substitutes
Anti-Infective Agents, Local
Anti-Infective Agents