A Phase 1 interventional study of Povidone-Iodine and Normal saline in Coronavirus Infection, sponsored by Hampshire Hospitals NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-17.
Sponsored by Hampshire Hospitals NHS Foundation Trust · Phase 1, Interventional, and Treatment
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.
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 :
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Hampshire Hospitals NHS Foundation Trust is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
0.23% sinus rinse and mouthwash three times daily (tds) for days 1-3 of study
Drug: Povidone-Iodine
sinus rinse and mouthwash three times daily (tds) for days 1-3 of study
Drug: Normal saline
0.23% three times daily (tds) for 3 days
Also known as: Videne Antiseptic Solution
0.9% three times daily (tds) for 3 days
Change in viral load in the oral and nasopharyngeal cavity
viral load as measured by real time polymerase chain reaction (PCR)
Time frame: Day 0, 2, 3, 7, 14
Symptom severity in primary participants and co-residents
Visual analogue score 1-5 per symptom via a smartphone app
Time frame: Days 0 to 14
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Hampshire Hospitals NHS Foundation Trust