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

Stanford University

Status and phase: Completed; Phase 2; Phase 1

Conditions: COVID-19

Treatments: Drug: Povidone-Iodine 0.5%; Drug: Povidone-Iodine 2%; Drug: Isotonic saline 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT04347954

IRB-56134

Details and patient eligibility

About

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."

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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47 participants in 3 patient groups, including a placebo group

Povidone-Iodine 2%

Experimental group

Description:

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.

Treatment:

Drug: Povidone-Iodine 2%

Povidone-Iodine 0.5%

Experimental group

Description:

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

Treatment:

Drug: Povidone-Iodine 0.5%

Isotonic saline 0.9%

Placebo Comparator group

Description:

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.

Treatment:

Drug: Isotonic saline 0.9%