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

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 effect profile, and high tolerability with daily use.

Hypothesis 2: Twice a day dosing for six weeks will prove safe in this subject population.

Healthy volunteers living in the Boston area between the ages of 18 and 70 years old will be recruited for participation in this study.

Consenting subjects will undergo baseline testing to confirm participants eligibility for this trial. As mentioned above, the target for enrollment is 50 subjects, so it is anticipated that approximately 75 subjects will be recruited, consented, and screened/tested, with about 25 of those subjects being either ineligible after testing or unable to complete the full 12 weeks of the trial. Subjects will apply 3M's PVP-I nasal swabs either once (control group) or twice (treatment group) per day, depending on the group that participants are randomized into. Subjects will apply the nasal swabs daily for six weeks with weekly symptom assessments and testing. After subjects cease nasal swab application, participants will return after another six weeks (i.e. 12 weeks after participants first nasal swab application) for a final round of testing and symptom assessment. Subjects will not need to pay for any nasal swabs or visits during this trial - all study-related items and visits will be covered by the sponsor. Subjects will also be remunerated with up to 100 dollars in gift certificates if participants complete the study and attend the check-ins (50 dollar certificate for completing baseline visit and 50 dollar certificate for coming in at 12 weeks).