Phase I/II Trial of Povidone-iodine (PVP-I) Nasal Swab For Preventing COVID-19 Spread in Healthy Subjects

• Status: Not yet recruiting
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Title: Phase I/II Trial (Safety and Dosing) of Povidone-iodine (PVP-I) Nasal Swab For Preventing COVID-19 Spread in Healthy Subjects:

Summary: This study will evaluate in a PH I/II trial in healthy volunteers the safety and tolerability of PVP-I nasal swabs daily application. The intent is to follow with a PH III randomized controlled clinical trial to assess the capacity for PVP-I nasal swabs to mitigate the transmission of respiratory viruses specifically COVID 19.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: 3M
• Treatments: Povidone-Iodine

Criteria

Inclusion Criteria:

1. Healthy volunteers from the Boston community

2. 18-70 years of age

3. In good health, without thyroid or cardiac disease, without symptoms of COVID-19*

4. Normal baseline TSH

Exclusion Criteria:

1. History of thyroid or cardiac disease

2. Current BWH employee

3. Allergy or hypersensitivity to iodine

4. Positive COVID-19 mRNA or antibody test

5. Participation in any other investigational study or drug trial in which receipt of an investigational study drug occurred within 30 days prior to enrollment in this study

6. Women who are pregnant or attempting to conceive

7. Men who are attempting to conceive with their partner