Covid-19 MedDRA version: 20.0 Level: LLT Classification code 10061986 Term: SARS System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Vedine/Betadine
Product Name: Vedine/Betadine
Pharmaceutical Form: Oromucosal solution
INN or Proposed INN: iodonated Povidone
CAS Number: 9003-39-8
Current Sponsor code: nil
Other descrip
Sponsors
Hampshire Hospitals NHS TRust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Staff who have tested positive for COVID -19 AND in isolation at home. Patients who have been tested positive for Covid-19 on general wards or about to be discharged who are well enough to self administer nasal washes. Household member of affected staff member and household members of affected patients on general ward once discharged to home self-isolation 18 years and over Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Known hypersensitivity to Iodine Those at risk of aspiration due to unsafe swallow Those unable to perform treatment themselves Under 18 years of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does Povidine-Iodine reduce the amount of virus in the nose and throat when applied via a sinus rinse/mouth wash?;Secondary Objective: Does Povidine-Iodine as a nose rinse/mouthwash reduce transmission of the virus to co-residents? Does Povidine-Iodine reduce the symptom severity in postive individuals as reported by self reported questionnaire via smart phone app? ;Primary end point(s): The primary outcome measure will be the change in Viral load in the two arms as measured by real time PCR.;Timepoint(s) of evaluation of this end point: Day 0,2,4,7 and 14 of trial period via oral and nasopharyngeal swabs | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Reduced symptom severity in covid-19 positive participants. Symptoms will be measured by a aggregate symptom score collected by smartphone app. Each symptom scored on a visuala visual analogue scale 0-5 (0-No symptoms-5 severe). Reduced transmission of virus as assessed by percentage of household with postivity for covid-19.;Timepoint(s) of evaluation of this end point: Day 1 to Day 14 of trial period | — |
Countries
United Kingdom
Contacts
Public ContactChief Investigator
Hampshire Hospitals NHS TRust
Outcome results
None listed