Status:
UNKNOWN
Phase I/II Trial of Povidone-iodine (PVP-I) Nasal Swab For Preventing COVID-19 Spread in Healthy Subjects
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
3M
Conditions:
Covid19
Povidone Iodine Adverse Reaction
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief 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 v...
Detailed Description
Specific Aim 1: Evaluate toxicity and tolerability of PVP-I nasal swabs Specific Aim 2: Investigate the dosing of PVP-I nasal swabs. Hypothesis 1: PVP-I nasal swabs have a low toxicity, low side effe...
Eligibility Criteria
Inclusion
- Healthy volunteers from the Boston community
- 18-70 years of age
- In good health, without thyroid or cardiac disease, without symptoms of COVID-19\*
- Normal baseline TSH
Exclusion
- History of thyroid or cardiac disease
- Current BWH employee
- Allergy or hypersensitivity to iodine
- Positive COVID-19 mRNA or antibody test
- 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
- Women who are pregnant or attempting to conceive
- Men who are attempting to conceive with their partner
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04510402
Start Date
August 1 2020
End Date
April 1 2021
Last Update
August 12 2020
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