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

NCT ID: NCT04347954

Last Updated: 2021-10-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-15

Study Completion Date

2020-12-13

Brief Summary

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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."

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Povidone-Iodine 2%

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Povidone-Iodine 0.5%

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Isotonic saline 0.9%

Intervention Type DRUG

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

Interventions

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Povidone-Iodine 2%

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

Intervention Type DRUG

Povidone-Iodine 0.5%

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

Intervention Type DRUG

Isotonic saline 0.9%

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jayakar V. Nayak, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Neelaysh Vukkadala, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford Health Care

Stanford, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB-56134

Identifier Type: -

Identifier Source: org_study_id