The purpose of trial is to determine if daily usage of a photobiomodulation device will decrease the incidence of upper respiratory tract infections (URI) due to COVID, influenza or other viruses.The RD-X10 device is handheld, can be self-administered, and has been shown to be safe in invivo studies.

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.

Group 1: Active RD-X19 every other day for 3 months Group 2: Sham RD-X19 every other day for 3 months

Visit 1 (week 0) (may be same day as screening visit) (approx. 30 minutes):

• Subject will be given the RD-X19 device and shown how to use the device
• Subjects will be instructed to use the device for 5 minutes every other day
• Subject will be given "Instructions for Treatment" handout

Visits 2-7 (weeks 2-12) (approx. 30 min) can be performed virtually or in person

• Subjects will be asked if they have experienced any upper respiratory symptoms in the last 2 weeks, this may include cough, congestion, sore throat, fatigue, runny nose, sinus pain or pressure, fever (subjective or Temp >100 F), sneezing.
• Subjects experiencing any of the above symptoms will be tested for URI causing viruses using PCR based testing.
• 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. They will also be assessed daily using the WURSS 24 (Wisconsin Upper Respiratory Symptom Survey) daily symptom report until they report a score of 0 for question 1 (How sick do you feel today?)
• Subjects who have not experienced any URI symptoms will be assessed for adherence to RDX19 over the previous 2 weeks and encouraged to continue using the device. They will also be asked if they are experiencing any side effects of the treatment such as throat or mouth irritation, sores in the mouth or on the lips or any other perceived side effects.

Device will only be used for a single patient and should be returned to research staff at the end of the study for disposal.

Inclusion Criteria:

• Active Duty and DoD Beneficiaries (i.e. former military, spouse, dependent child) aged 18 years and older who work in the Mike O'Callaghan Military Medical Center at Nellis Air Force Base.

Exclusion Criteria:

• Unable to comfortably insert RD-X19 into the mouth and keep in place for 5 minutes
• Plans for head, neck or mouth surgery during the study period
• Plans for major dental procedures (ie implants, wisdom teeth extraction etc) during the study

Demographic and clinical data will be acquired from participants. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier for the NLM Data Archive (NDA) (clinicaltrials.gov) will be collected for each subject. Sufficient data from this project will be preserved to enable sharing via NDA data of sufficient quality to validate and replicate research findings described in the Aims. NLM requires data measured from human subjects to be shared using the NDA. Demographic data, clinical data, data collection tools and study protocols will be made available in the NDA.

All data will be deposited to clinicaltrials following the usual NDA data submission dates.

Data will be findable for the research community through the NDA Collection that will be established when this application is funded. For all publications, an NDA study will be created. Each of those studies is assigned a digital object identifier (DOI). This data DOI will be referenced in the publication to allow the research community easy access to the exact data used in the publication.

The research community will have access to data when the study ends. As required by NDA, studies will also be created that contain the data used for every publication. Those studies will be shared when the pre-print is available. NDA studies have digital object identifiers (DOI) to aid in findability. We will include that DOI in relevant publications. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.

double blind