PVP-I Nasal Sprays and SARS-CoV-2 Nasopharyngeal Titers (for COVID-19)
Summary
The study aims to determine the safety and efficacy of povidone-iodine (PVP-I) containing nasal sprays as compared to isotonic saline nasal sprays in COVID-19 positive patients. The primary outcome measure is SARS-CoV-2 viral titers in the nasal cavity and nasopharynx. In vitro studies have shown PVP-I to be highly virucidal against the viruses which cause SARS and MERS. Additionally, clinical studies have shown PVP-I saline sprays to be well tolerated in human subjects. PVP-I oral rinses and sprays have been trialed as methods to reduce the incidence and symptoms of viruses which cause the "common cold."
Timeline
- Start
- 2020-08-15
- Primary completion
- 2020-12-13
- Completion
- 2020-12-13
Outcome
Missed primary endpoint
registry analysis (other test); Isotonic Saline 0.9% vs Povidone-Iodine 0.5%; Mean Difference (Net) -0.349 (95% CI -1.584 to 0.886) NCT04347954 ↗
registry analysis (other test); Isotonic Saline 0.9% vs Povidone-Iodine 2%; Mean Difference (Net) -1.059 (95% CI -2.318 to 0.201) NCT04347954 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Povidone-Iodine | Other / unclassified | 0.5 % | Intranasal |
| Subject | Povidone-Iodine | Other / unclassified | 2 % | Intranasal |