Virucidal pilot study of Nasodine® (povidone-iodine 0.5%) nasal spray in people in South Africa with COVID-19 and confirmed nasal shedding of SARS-CoV-2 virus.

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000034831

Enrollment

Registered

2021-01-15

Start date

2020-11-20

Completion date

2020-12-15

Last updated

2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of this pilot study is to provide an indication that the in vitro disinfectant activity seen against the SARS-CoV-2 virus translates to disinfection of the nasal cavity in vivo of COVID-19 patients in South Africa. Other objectives include collecting data to guide follow-on clinical studies and to provide insights as to mode of action. Overall, the study will provide important insights into the potential role for a PVP-I nasal spray in managing the risk of infection by the virus.

Interventions

Intervention is an aqueous buffered solution of 0.5% povidone-iodine (PVP-I) contained in a 30 mL bottle closed with a traditional nasal spray pump. Subjects will receive a single dose to their nasal passages, administered by the investigator. The amount a subject receives consists of 8 x 140µL pump actuations (4 into each nostril), being 1.12 mL total volume.

Study design

Allocation

Non-randomised trial

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Adult (18+ years old) patients with (a) confirmed COVID-19 symptoms and (b) symptom onset within the past five days.

Exclusion criteria

• Known iodine sensitivity • Previously diagnosed thyroid disease • Previously diagnosed kidney disease • Known to be pregnant or currently breastfeeding

Outcome results