Phase 2
N=98
COVID-19: Povidone-Iodine Intranasal Prophylaxis in Front-line Healthcare Personnel and Inpatients
COVID-19 · SARS-CoV 2
Bottom Line
View on ClinicalTrials.gov: NCT04364802 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Percent of Healthcare Workers Testing Positive for COVID-19. — 0; 0 percentage of healthcare workers
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Povidone-Iodine Nasal Spray and Gargle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nikita Gupta
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Healthcare Workers Testing Positive for COVID-19. |
0; 0 | — |
| PRIMARY Percent of Patients Testing Positive for COVID-9. |
0; 0 | — |
| PRIMARY Percent of Community Participants Testing Positive for COVID-9. |
0; 0 | — |
| SECONDARY PVP-I Ease of Use |
4.48; 4.43; 4.77 | — |
| SECONDARY PVP-I Comfort |
3.25; 4.00; 3.00 | — |
Summary
Povidone-iodine (PVP-I) is a broad-spectrum antiseptic with activity against bacteria, fungi, and viruses. It has been previously used in both intranasal preparations against Methicillin Resistant Staphylococcus Aureus (MRSA) as well as oral preparations in in-vitro studies of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV), Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV), influenza H1N1, and rotavirus with good efficacy. This study will evaluate the efficacy of PVP-I as prophylaxis in Coronavirus Disease 2019 (COVID19)-negative front-line health care workers, hospital patients, and community members.
Eligibility Criteria
Inclusion Criteria
- healthcare worker OR
- patient with expected hospital stay of 7+ days OR
- patient admitted for major surgery OR
- community member
- COVID19 negative by nasal swab test
- asymptomatic for COVID19
- able to consent
Exclusion Criteria
- positive for COVID19 by nasal swab
- symptomatic for COVID19
- unable to consent
Data sourced from ClinicalTrials.gov (NCT04364802). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.