SINUS WASH Pilot Study in Adults Testing Positive for COVID-19
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|ClinicalTrials.gov Identifier: NCT04393792|
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : May 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Coronavirus Infection||Drug: Povidone-Iodine Drug: Normal saline||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||unblinded parallel group design with 1:1 randomised allocation to treatment or control|
|Masking:||None (Open Label)|
|Official Title:||Can a Sinus Rinse and Mouth Wash Reduce Viral Load in COVID-19 Positive Individuals and Their Co-residents?|
|Estimated Study Start Date :||May 2020|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
Active Comparator: Povidone-Iodine
0.23% sinus rinse and mouthwash three times daily (tds) for days 1-3 of study
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
- 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)
- 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
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
|Contact: Afroze Khan, MBBS MRCS||+447885903693||Afroze.Khan@nhs.net|
|Contact: Matthew Drydenfirstname.lastname@example.org|
|Hampshire Hospitals NHS Foundation Trust||Recruiting|
|Basingstoke, Hampshire, United Kingdom, RG24 9NA|
|Contact: Afroze Khan, MBBS MRCS|
|Contact: Matthew Dryden|
|Principal Investigator:||Afroze Khan, MBBS MRCS||Hampshire Hospitals NHS Foundation Trust|