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

NCT04347954 | Completed Phase 1 Results FDA Drug

• 1 other identifier: IRB-56134
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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."

Conditions

COVID-19

Keywords

nasal spray; PVP-I; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Count of Participants Experiencing Adverse Events of Interest After Nasal Sprays

  Assessed on days 3 and 5

• Count of Participants Experiencing Fevers as a Measure of Frequency of Symptoms Related to SARS-CoV-2

  Assessed on days 3 and 5

• Count of Participants Experiencing Chills as a Measure of Frequency of Symptoms Related to SARS-CoV-2

  Assessed on days 3 and 5

• Count of Participants Experiencing Fatigue as a Measure of Frequency of Symptoms Related to SARS-CoV-2

  Assessed on days 3 and 5

• Count of Participants Experiencing Loss of Sense of Smell as a Measure of Frequency of Symptoms Related to SARS-CoV-2

  Assessed on days 3 and 5

Study Arms (3)

Povidone-Iodine 2%

EXPERIMENTAL

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%

Povidone-Iodine 0.5%

EXPERIMENTAL

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%

Isotonic saline 0.9%

PLACEBO COMPARATOR

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%

Interventions

Povidone-Iodine 2% DRUG

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

Povidone-Iodine 2%

Povidone-Iodine 0.5% DRUG

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

Povidone-Iodine 0.5%

Isotonic saline 0.9% DRUG

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

Isotonic saline 0.9%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of COVID-19 by lab test within 5 days of study participation

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Health Care

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

The study did not meet its accrual goal of 45 participants with analyzable data.

Results Point of Contact

• Title: Jayakar Nayak, MD, PhD
• Organization: Stanford University

jnayak@stanford.edu

(650) 723-5281

Study Officials

• Jayakar V. Nayak, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Neelaysh Vukkadala, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 15, 2020
• Study Start: August 15, 2020
• Primary Completion: December 13, 2020
• Study Completion: December 13, 2020
• Last Updated: October 21, 2021
• Results First Posted: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)