UnknownPhase 1/2

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

50 participantsStarted 2020-08

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Number of participants with treatment-related adverse events as assessed by self reporting, metabolic and endocrine metrics

Timeframe: follow up until 12 weeks

Trial details

NCT IDNCT04510402

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-02

Contact for this trial

Raymond M Anchan, MD, PhD

6177324285 ranchan@bwh.harvard.edu

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