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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04347954
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Stanford University

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."

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Povidone-Iodine 2% Drug: Povidone-Iodine 0.5% Drug: Isotonic saline 0.9% Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of PVP-I Nasal Sprays vs Normal Saline Nasal Sprays on SARS-CoV-2 Nasopharyngeal Titers
Actual Study Start Date : August 15, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Povidone-Iodine 2%

Participants will administer PVP-I 2% nasal spray for 5 days. Nasopharyngeal swabs will be taken on Day 1 at baseline, Day 1 at four hours post-first dose, and Day 5.

Participants will complete a daily symptom journal from Day 1 through Day 5.

Drug: Povidone-Iodine 2%
Two sprays to each nare of PVP-I 2% via nasal spray bottle, four times a day

Experimental: Povidone-Iodine 0.5%

Participants will administer PVP-I 0.5% nasal spray for 5 days. Nasopharyngeal swabs will be taken on Day 1 at baseline, Day 1 at four hours post-first dose, and Day 5.

Participants will complete a daily symptom journal from Day 1 through Day 5

Drug: Povidone-Iodine 0.5%
Two sprays to each nare of PVP-I 0.5% via nasal spray bottle, four times a day

Placebo Comparator: Isotonic saline 0.9%

Participants will administer two sprays of isotonic saline nasal spray for 5 days. Nasopharyngeal swabs will be taken on Day 1 at baseline, Day 1 at four hours post-first dose, and Day 5.

Participants will complete a daily symptom journal from Day 1 through Day 5.

Drug: Isotonic saline 0.9%
Two sprays to each nare of isotonic saline (0.9% NaCl) via nasal spray bottle, four times a day




Primary Outcome Measures :
  1. Mean change in viral titers of SARS-CoV-2 [ Time Frame: Day 1 (baseline), Day 1 (4 hours), Day 5 ]
    Nasopharyngeal swabs will be obtained and quantitative polymerase chain reaction (PCR) testing will be performed to determine the viral load in the nasopharynx


Secondary Outcome Measures :
  1. Frequency of adverse effects of interest after nasal sprays [ Time Frame: Up to 5 days ]

    Adverse effects of interest include:

    • Nasal burning/pain
    • Headaches
    • Ear pain
    • Sneezing
    • Nose bleeds

  2. Frequency of symptoms related to SARS-CoV-2 [ Time Frame: Up to 5 days ]

    Symptoms of interest include:

    • Fever
    • Fatigue
    • Change in smell
    • Change in taste
    • Nasal obstruction
    • Chills
    • Sore throat

  3. Compliance with study drug administration [ Time Frame: Up to 5 days ]
    Self report by participants (survey) of estimated doses completed.

  4. Change from baseline in University of Pennsylvania Smell Identification Test (UPSIT) [ Time Frame: Day 1 (baseline), Day 30 ]
    Participants scratch the cards and attempt to identify the smell from a multiple choice set of options. Their scores are then computed and categorized as normal, mild, moderate, or severe microsmia (loss of smell).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04347954


Locations
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United States, California
Stanford Health Care Recruiting
Stanford, California, United States, 94305
Contact: Study Team    650-725-6500    covid19study@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Jayakar V. Nayak, MD, PhD Stanford University
Principal Investigator: Neelaysh Vukkadala, MD Stanford University
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04347954    
Other Study ID Numbers: IRB-56134
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Stanford University:
nasal spray
PVP-I
COVID-19
Additional relevant MeSH terms:
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Iodine
Cadexomer iodine
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes