Light-based Immunomodulation for Guarding Against Human Respiratory Tract Infections

Methods: Subjects 18 years and older working at a DoD medical facility and VA medical facility will be randomized into Active Treatment (Emit Bio ) and sham (inactive device). Basic demographic information will be obtained. Subjects will use the device at home every other day for 5 minutes. Baseline viral upper respiratory PCR panel will be obtained to ensure pre-existing infections are not counted. At first sign of upper respiratory infection symptoms, subjects will contact research personnel and have viral respiratory PCR panel obtained. Research coordinators will also contact subjects every two weeks to ask if they are experiencing or have experienced any upper respiratory symptoms or if they have experienced any side effects of treatment. Subjects reporting any current symptoms or symptoms in the prior 2 weeks will have upper respiratory PCR panel obtained. Any subjects with confirmed or unconfirmed PCR URI will be contacted daily until symptoms subside to assess secondary outcomes including duration of symptoms, missed days of work, outpatient medical visits, ED visits, hospitalizations, medication prescriptions for respiratory illness and over the counter treatments.

Screening visit (Approx 30 min):

• Obtain and document signed Informed Consent document and HIPAA Authorization
• Verify subject eligibility based on inclusion/exclusion criteria (research coordinators may use the electronic medical record to verify inclusion/exclusion)
• Record all medications the subject is taking
• Collect demographic information to include phone number, email address, DoD ID, age, race, ethnicity, sex, whether they directly care for patients, what department they work in, any therapies regularly used to prevent URI (ie zinc, mouth washes, supplements), and immunocompromised state or medications that may suppress the immune system, weight (pounds), height (inches), and BMI

Randomization:

Subjects will be randomized using block randomization (blocks of 6) into one of two research treatment groups, with approximately 50 subjects in each arm for a total of 100 subjects. The study staff assigning subjects to their group will be unblinded to the groups, but patients, investigators, and study staff conducting screening and gathering data will be blinded. The unique study code will be assigned in sequential order beginning with 001.