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

NCT04347954 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2021-10-21

Study results available
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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

Interventions

DRUG

Povidone-Iodine 2%

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

DRUG

Povidone-Iodine 0.5%

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

DRUG

Isotonic saline 0.9%

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

Sponsors & Collaborators

Principal Investigators

  • Jayakar V. Nayak, MD, PhD · Stanford University

  • Neelaysh Vukkadala, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-15
Primary Completion
2020-12-13
Completion
2020-12-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04347954 on ClinicalTrials.gov