PVP-I Nasal Sprays and SARS-CoV-2 Nasopharyngeal Titers (for COVID-19)

COVID-19 Clinical Trial

Official title:

Effect of PVP-I Nasal Sprays vs Normal Saline Nasal Sprays on SARS-CoV-2 Nasopharyngeal Titers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04347954
• Other study ID #: IRB-56134
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 15, 2020
• Est. completion date: December 13, 2020

Study information

• Verified date: October 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 13, 2020
• Est. primary completion date: December 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Povidone-Iodine 2%
Two sprays to each nare of PVP-I 2% via nasal spray bottle, four times a day
• Povidone-Iodine 0.5%
Two sprays to each nare of PVP-I 0.5% via nasal spray bottle, four times a day
• Isotonic saline 0.9%
Two sprays to each nare of isotonic saline (0.9% NaCl) via nasal spray bottle, four times a day

Locations

Country	Name	City	State
United States	Stanford Health Care	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Cycle Threshold (Ct) Values Through Day 3 as a Measure of Change in Viral Titers of SARS-CoV-2	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 considered the lower limit of detection of this RT-PCR test for SARS-CoV-2.	Day 1 (baseline), Day 1 (1 hour), Day 3
Secondary	Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays	Participants were asked on day 3 whether they experienced the adverse event since baseline, then asked on day 5 whether they experienced the adverse event since day 3 (collected by questionnaire). Adverse events of interest include: Nasal burning/pain, headaches, ear pain, sneezing, and nose bleeds.	Assessed on days 3 and 5
Secondary	Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2	Count of participants that experienced fevers at either mild, moderate, or severe intensity. Participants were asked on day 3 whether they experienced the symptom since baseline, then asked on day 5 whether they experienced the symptom since day 3. Participants rated the severity of their symptoms on a 4-point Likert scale with "1" representing 'not experiencing that symptom,' "2" representing mild symptoms, "3" representing 'moderate symptoms,' and "4" representing 'severe symptoms.'	Assessed on days 3 and 5
Secondary	Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2	Count of participants that experienced chills at either mild, moderate, or severe intensity. Participants were asked on day 3 whether they experienced the symptom since baseline, then asked on day 5 whether they experienced the symptom since day 3. Participants rated the severity of their symptoms on a 4-point Likert scale with "1" representing 'not experiencing that symptom,' "2" representing mild symptoms, "3" representing 'moderate symptoms,' and "4" representing 'severe symptoms.'	Assessed on days 3 and 5
Secondary	Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2	Count of participants that experienced fatigue at either mild, moderate, or severe intensity. Participants were asked on day 3 whether they experienced the symptom since baseline, then asked on day 5 whether they experienced the symptom since day 3. Participants rated the severity of their symptoms on a 4-point Likert scale with "1" representing 'not experiencing that symptom,' "2" representing mild symptoms, "3" representing 'moderate symptoms,' and "4" representing 'severe symptoms.'	Assessed on days 3 and 5
Secondary	Count of Participants Experiencing Loss of Sense of Smell as a Measure of Frequency of Symptoms Related to SARS-CoV-2	Count of participants that experienced loss of sense of smell at either mild, moderate, or severe intensity. Participants were asked on day 3 whether they experienced the symptom since baseline, then asked on day 5 whether they experienced the symptom since day 3. Participants rated the severity of their symptoms on a 4-point Likert scale with "1" representing 'not experiencing that symptom,' "2" representing mild symptoms, "3" representing 'moderate symptoms,' and "4" representing 'severe symptoms.'	Assessed on days 3 and 5
Secondary	Count of Participants Experiencing Loss of Sense of Taste as a Measure of Frequency of Symptoms Related to SARS-CoV-2	Count of participants that experienced loss of sense of taste at either mild, moderate, or severe intensity. Participants were asked on day 3 whether they experienced the symptom since baseline, then asked on day 5 whether they experienced the symptom since day 3. Participants rated the severity of their symptoms on a 4-point Likert scale with "1" representing 'not experiencing that symptom,' "2" representing mild symptoms, "3" representing 'moderate symptoms,' and "4" representing 'severe symptoms.'	Assessed on days 3 and 5
Secondary	Count of Participants Experiencing Nasal Congestion as a Measure of Frequency of Symptoms Related to SARS-CoV-2	Count of participants that experienced nasal congestion at either mild, moderate, or severe intensity. Participants were asked on day 3 whether they experienced the symptom since baseline, then asked on day 5 whether they experienced the symptom since day 3. Participants rated the severity of their symptoms on a 4-point Likert scale with "1" representing 'not experiencing that symptom,' "2" representing mild symptoms, "3" representing 'moderate symptoms,' and "4" representing 'severe symptoms.'	Assessed on days 3 and 5
Secondary	Count of Participants Experiencing Sore Throat as a Measure of Frequency of Symptoms Related to SARS-CoV-2	Count of participants that experienced sore throat at either mild, moderate, or severe intensity. Participants were asked on day 3 whether they experienced the symptom since baseline, then asked on day 5 whether they experienced the symptom since day 3. Participants rated the severity of their symptoms on a 4-point Likert scale with "1" representing 'not experiencing that symptom,' "2" representing mild symptoms, "3" representing 'moderate symptoms,' and "4" representing 'severe symptoms.'	Assessed on days 3 and 5
Secondary	Compliance With Study Drug Administration	Participants were asked to estimated doses completed at day 5 (0-25%, 26-50%, 51-75%, or 76-100%). The count of participants who estimated their compliance to be within each range is reported.	5 days
Secondary	Count of Participants Normosmia, Microsmia, or Anosmia as a Measure of Change in the University of Pennsylvania Smell Identification Test (UPSIT)	Participants scratch test cards and attempt to identify the smell from a multiple choice set of options. Their scores are then computed and categorized as normosmia (normal), mild, moderate, or severe microsmia (loss of smell), or anosmia (total loss of smell).	Day 1 (baseline), Day 30