A pilot study of the ability of povidone-iodine (PVP-I) 0.5% aqueous solution oral/nasal spray and mouthwash to kill the SARS-CoV-2 virus in people with COVID-19

Not Applicable

• Conditions: COVID-19 (SARS-CoV-2 infection); Infections and Infestations

• Registration Number: ISRCTN13447477
• Lead Sponsor: Royal Surrey County Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-22
• Last Update Posted: 2 November 2020
• Study Completion: 2021-02-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Adults aged =18 years and =75 years
2. Have confirmed COVID-19 symptoms and symptom onset within the past 10 days
3. Recently (within last 3-4 days) hospitalised with COVID-19 disease
4. COVID-19 disease proven by PCR testing for SARS-CoV-2 within the last 4 days
5. Capable of using a nasal spray device and the mouthwash required by the trial
6. Capacity and capability to give informed consent to take part in the trial

Exclusion Criteria

1. Known sensitivity to PVP-I aqueous antiseptic solution or any of its listed excipients
2. Previously diagnosed thyroid disease
3. Chronic renal failure (stage =3 by eGFR MDRD)
4. Acute renal failure (KDIGO =stage 2: creatinine =2x baseline)
5. Known pregnancy or currently breastfeeding
6. Current requirement for invasive or non-invasive ventilation or planned within next 6 hours
7. Patient undergoing or soon to undergo radioiodine treatment
8. Known dermatitis herpetiformis (Duhring's disease)
9. Current participation in research that is designed to, or is expected to alter the COVID-19 disease course or viral load.
10. Inability to communicate in English or read English

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amounts of cultured SARS-CoV-2 and quantitative PCR results of viral RNA in saliva and nasal samples at baseline, and 5 further time points up to 2 h after administration. Results will be expressed as actual counts per ml saliva and the mean log reduction after application of PVP-I determined, taking into account any dilution effect by the mouthwash or spray which will be analysed in a control group given water instead of PVP-I

Secondary Outcome Measures

Name	Time	Method
Salivary viral loads after administration of PVP-I nasal spray or PVP-I mouthwash, at baseline, 5, and 20 min