Phase I/II Trial 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).

Baseline screening will assess the overall health of the subject, confirm that participants
have no underlying cardiac or thyroid conditions, participants are not pregnant (serum hCG
testing will confirm this) nor intend to conceive during the course of this trial, and that
participants are not experiencing any symptoms of COVID-19 (e.g. coughing, fever, shortness
of breath). Further, testing will include thyroid stimulating hormone (TSH), thyroid
peroxidase (TPO) antibody, serum human chorionic gonadotropin (hCG; to test for pregnancy),
urine iodine, and COVID-19 mRNA (for the presence of an active virus) and antibody (as
evidence for previous COVID-19 infection). Some of these tests will be administered weekly,
at baseline only, at six weeks, or at 12 weeks. All research-related phlebotomy for this
study will take place at BWH clinical research phlebotomy labs, such as the Clinical Trials
Hub at 60 Fenwood Road or the Clinical Trials Center at 15 Francis Street. Again, all tests
are covered by study funding and subjects will never be charged for them.

Once subjects' test results are returned and participants are deemed eligible for the study,
participants will meet with the investigator in a clinical exam room (with masks and 6 feet
social distance), and the investigator will demonstrate how to apply the nasal swabs so that
the subject can continue to apply the swabs by themselves for the duration of the study. The
investigator will assure that the subject has learned how to apply the nasal swab correctly
and safely and that the subject understands the importance of daily, regimented application.
Alternatively, if the subject would prefer to minimize in-person contact with others,
participants can obtain the study drug from the investigator or study staff and learn how to
apply the swabs through a Zoom meeting. Further, a video detailing these instructions will be
sent to subjects with detailed application instructions.

Subjects will also be given a questionnaire to fill out at each weekly check-in, which will
assess any side effects participants may be experiencing related to this drug (questionnaire
is attached to this IRB submission on Insight). Questions will be focused on symptoms of
hyperthyroidism (e.g. palpitations, tremulousness, weight loss, irritability) and
hypothyroidism (e.g. fatigue, weight gain, sluggishness, hair loss). Subjects will also be
informed at the time of enrollment that if participants start experiencing any troubling side
effects, participants should stop applying swabs and alert study staff or an investigator of
these side effects as soon as participants can. If this happens, or if a subject's test
results reveal markers that are outside of reference ranges, participants will be withdrawn
from the study and investigators will explain why participants are being withdrawn.
Investigators will closely monitor the safety of patients and alert the FDA and the BWH IRB
if any adverse events occur. However, given the proven safety of PVP-I and the weekly testing
and assessments the investigators are conducting, the investigators do not anticipate that
any adverse events will occur.

The overall study, from initiation and patient recruitment to data analysis and synthesis of
a detailed report is anticipated to take six months.