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NCT04347954 · ClinicalTrials.gov registry record · Phase 1
PVP-I Nasal Sprays and SARS-CoV-2 Nasopharyngeal Titers (for COVID-19)
A Phase 1 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT04347954: Completed Phase 1 study, sponsored by Stanford University.
NCT04347954 is a Phase 1 study that has completed, run by Stanford University. The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04347954, a Phase 1 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study 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."
Primary Outcome
Nasopharyngeal swabs were obtained and quantitative reverse transcription-polymerase chain reaction (RT-PCR) testing was performed to determine the viral load in the nasopharynx. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to \~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is consider
Interventions
- DRUG Povidone-Iodine 2%
- DRUG Povidone-Iodine 0.5%
- DRUG Isotonic saline 0.9%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2020-08-15 |
| Est. Completion | 2020-12-13 |
| Phase | Phase 1 |
What the finished NCT04347954 record still lists
NCT04347954 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 3 interventions - of which Povidone-Iodine 2% is the first listed.
NCT04347954 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04347954 about?
NCT04347954 is a clinical study titled "PVP-I Nasal Sprays and SARS-CoV-2 Nasopharyngeal Titers (for COVID-19)". 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 PV...
What is the current status of trial NCT04347954?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2020-08-15. Estimated completion is 2020-12-13.
What interventions are being tested in trial NCT04347954?
The interventions under investigation include: Povidone-Iodine 2% (DRUG), Povidone-Iodine 0.5% (DRUG), Isotonic saline 0.9% (DRUG).
Who is sponsoring clinical trial NCT04347954?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04347954's enrollment target sits among peer trials
47 1053rd of 2000 higher than 943 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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