Phase 2
N=47
PVP-I Nasal Sprays and SARS-CoV-2 Nasopharyngeal Titers (for COVID-19)
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04347954 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Mean Cycle Threshold (Ct) Values Through Day 3 as a Measure of Change in Viral Titers of SARS-CoV-2 — 24.36; 26.03; 28.42; 25.71 cycles
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Povidone-Iodine 2% (Drug); Povidone-Iodine 0.5% (Drug); Isotonic saline 0.9% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Cycle Threshold (Ct) Values Through Day 3 as a Measure of Change in Viral Titers of SARS-CoV-2 |
24.36; 26.03; 28.42; 25.71; 26.46; 27.45 | — |
| SECONDARY Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays |
4; 2; 13; 2; 2; 13 | — |
| SECONDARY Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2 |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2 |
1; 0; 1; 2; 0; 0 | — |
| SECONDARY Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2 |
4; 5; 6; 1; 2; 0 | — |
| SECONDARY Count of Participants Experiencing Loss of Sense of Smell as a Measure of Frequency of Symptoms Related to SARS-CoV-2 |
2; 3; 2; 0; 2; 1 | — |
| SECONDARY Count of Participants Experiencing Loss of Sense of Taste as a Measure of Frequency of Symptoms Related to SARS-CoV-2 |
3; 4; 3; 0; 1; 0 | — |
| SECONDARY Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2 |
5; 5; 7; 3; 2; 4 | — |
| SECONDARY Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2 |
4; 0; 4; 0; 0; 0 | — |
| SECONDARY Compliance With Study Drug Administration |
11; 11; 13; 0; 0; 0 | — |
| SECONDARY Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT) |
2; 4; 5; 0; 0; 0 | — |
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."
Eligibility Criteria
Inclusion Criteria
- Diagnosis of COVID-19 by lab test within 5 days of study participation
Exclusion Criteria
- Allergy to "iodine, " shellfish, or food dye
- Receiving intranasal steroids
- Sinus surgery within 30 days of beginning the study
- Intubated at the time of enrollment
- Pregnancy
- Participation in other COVID-19 studies - to be determined on a case by case basis
Data sourced from ClinicalTrials.gov (NCT04347954). 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.