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

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.