Coronavirus InfectionPhase 1NCT04393792
SINUS WASH Pilot Study in Adults Testing Positive for COVID-19
A Phase 1 study testing Povidone-Iodine and Normal saline in people with Coronavirus Infection, run by Hampshire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infection
- What is being tested?
- Povidone-Iodine and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 May 2020to 30 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hampshire Hospitals NHS Foundation Trust
Basingstoke, Hampshire, RG24 9NA
About this study
Official title: 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.
Read the 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 :
- nose rinse and mouthwash with Isotonic saline alone. This will be the control arm.
- 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.
- Conditions
- Coronavirus Infection
- Being tested
- Povidone-Iodine, Normal saline
- Keywords
- COVID-19, sinus rinse, mouth wash, povidone-iodine, coronavirus, Wuhan
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-IodineDrug
Also called Videne Antiseptic Solution
0.23% three times daily (tds) for 3 days
Normal salineDrug
0.9% three times daily (tds) for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Povidone-Iodine | Active comparator | 0.23% sinus rinse and mouthwash three times daily (tds) for days 1-3 of study Receives: Drug: Povidone-Iodine |
| Normal Saline | Placebo comparator | sinus rinse and mouthwash three times daily (tds) for days 1-3 of study Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in viral load in the oral and nasopharyngeal cavity
viral load as measured by real time polymerase chain reaction (PCR)
Measured: Day 0, 2, 3, 7, 14
Secondary outcomes (1)
Symptom severity in primary participants and co-residents
Visual analogue score 1-5 per symptom via a smartphone app
Measured: Days 0 to 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start5 May 2020
- Primary completion30 Mar 2022
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- unblinded parallel group design with 1:1 randomised allocation to treatment or control
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hampshire Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Afroze Khan, MBBS MRCS, Principal investigator, Hampshire Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393792
- Sponsor's protocol ID
- SPON-AK-0420
- Other IDs
- 2020-001721-31
- Status last verified
- Oct 2026
- First submitted
- 18 May 2020
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Sinus Rinse and Mouth Wash Reduce Viral Load in COVID-19 Positive Individuals and Their Co-residents?
- ClinicalTrials.gov ID
- NCT04393792
- Acronym / sponsor ID
- SPON-AK-0420
- Conditions
- Coronavirus Infection
- Keywords
- COVID-19, sinus rinse, mouth wash, povidone-iodine, coronavirus, Wuhan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Hampshire Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 5 May 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 :
- nose rinse and mouthwash with Isotonic saline alone. This will be the control arm.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- unblinded parallel group design with 1:1 randomised allocation to treatment or control
| Arm | Type | Receives |
|---|---|---|
| Povidone-Iodine | Active comparator | Drug: Povidone-Iodine0.23% sinus rinse and mouthwash three times daily (tds) for days 1-3 of study |
| Normal Saline | Placebo comparator | Drug: Normal salinesinus rinse and mouthwash three times daily (tds) for days 1-3 of study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Povidone-IodineAlso: Videne Antiseptic Solution0.23% three times daily (tds) for 3 days | Drug | Povidone-Iodine |
| Normal saline0.9% three times daily (tds) for 3 days | Drug | Normal Saline |
Primary outcome
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)
1 secondary outcome
Symptom severity in primary participants and co-residents
Time frame: Days 0 to 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Afroze Khan, MBBS MRCS principal investigator
Hampshire Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Povidone-Iodine and Normal saline in people with Coronavirus Infection, run by Hampshire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in viral load in the oral and nasopharyngeal cavity (time frame: Day 0, 2, 3, 7, 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.