Clinical trial NCT04347954: PVP-I Nasal Sprays and SARS-CoV-2 Nasopharyngeal Titers (for COVID-19)
Official title: Effect of PVP-I Nasal Sprays vs Normal Saline Nasal Sprays on SARS-CoV-2 Nasopharyngeal Titers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: COVID-19
Keywords: nasal spray
PVP-I
COVID-19
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Mean Cycle Threshold (Ct) Values Through Day 3 as a Measure of Change in Viral Titers of SARS-CoV-2
timeFrame: Day 1 (baseline), Day 1 (1 hour), Day 3
Secondary outcomes:
measure: Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays
timeFrame: Assessed on days 3 and 5
measure: Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2
timeFrame: Assessed on days 3 and 5
measure: Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2
timeFrame: Assessed on days 3 and 5
measure: Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2
timeFrame: Assessed on days 3 and 5
measure: Count of Participants Experiencing Loss of Sense of Smell as a Measure of Frequency of Symptoms Related to SARS-CoV-2
timeFrame: Assessed on days 3 and 5
measure: Count of Participants Experiencing Loss of Sense of Taste as a Measure of Frequency of Symptoms Related to SARS-CoV-2
timeFrame: Assessed on days 3 and 5
measure: Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2
timeFrame: Assessed on days 3 and 5
measure: Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2
timeFrame: Assessed on days 3 and 5
measure: Compliance With Study Drug Administration
timeFrame: 5 days
measure: Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT)
timeFrame: Day 1 (baseline), Day 30
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Health Care
state: California
Study officials:
affiliation: Stanford University
name: Jayakar V. Nayak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Neelaysh Vukkadala, MD
role: PRINCIPAL_INVESTIGATOR
References: