Evaluation of the RD-X19 Treatment Device in Individuals With Mild COVID-19

Inclusion Criteria:

1. Positive for SARS-CoV-2 as detected using an FDA authorized SARS-CoV-2 antigen testat the screening/baseline visit.

2. Negative for Influenza A and B antigen using an FDA-authorized rapid diagnostictest.

3. At least two moderate or greater COVID-19 signs and symptoms from the followinglist: cough, sore throat, nasal congestion, headache, chills and/or sweats, myalgia,fatigue, nausea (with or without vomiting) or one moderate or greater symptom andfever (temperature ≥ 100.5 degrees F).

4. Time from appearance of first COVID-19 sign or symptom to screening must be 72 hoursor less.

5. Males or females, including pregnant and fecund females, 40 years of age and olderon the date of enrollment.

6. BMI <40

7. Provides written informed consent prior to initiation of any study procedures.

8. Be able to understand and agrees to fully comply with defined and described studyprocedures and be available for all study visits for the entire study duration.

9. Agrees to collection of a nasopharyngeal swab for qPCR at baseline for the purposesof assessing viral burden as a potential covariate in data analyses and for geneticsequencing to characterize the predominant SARS-CoV-2 variants present in the studypopulation.

10. Agrees to perform self-diagnostic home testing twice a day, separated by ≥ 6 hoursfor the entire length of the study.

11. Agrees to restrict medications used for symptomatic relief of signs and symptoms ofCOVID-19 during the study period, and, if used, to report ALL such medications (including home remedies) to the study staff.

12. Agrees to avoid the use of oral rinses and toothpastes containing alcohol-basedcompounds (e.g. Eucalyptol, Menthol, Thymol, Phenol) and/or Salicylates during thestudy period. Oral rinses, breath fresheners and toothpaste not containing thesecompounds are allowed.

13. Agrees to avoid nasal and sinus saline lavage during the study period.

14. No uncontrolled disease process (chronic or acute), other than COVID-19 signs andsymptoms (See section 8.1.1 - General Screening)*.

15. No physical or mental conditions or attributes at the time of screening, which inthe opinion of the PI, will prevent full adherence to, and completion of, theprotocol.

Exclusion Criteria:

1. Positive for Influenza A and B antigen using an FDA-authorized rapid diagnostictest.

2. Individuals < age 40 on study day 1.

3. Individuals who are symptomatic for COVID-19 for more than 72 hours on study day 1.

4. COVID-19 signs associated with moderate or greater disease with evidence of lowerrespiratory involvement including shortness of breath (SOB) at rest or as determinedby an exertional SOB protocol, SpO2 ≤94, respiratory rate ≥20 breaths per minute,heart rate ≥90 beats per minute, or abnormal pulmonary imaging.

5. Any medical disease or condition that, in the opinion of the site PrincipalInvestigator (PI) or appropriate sub-investigator, precludes study participation.

6. History of use of a rescue inhaler for uncontrolled asthma within one month of studyday 1.

7. History of recurrent alcohol intoxication or other recreational drug use (excludingmedically prescribed cannabis) within one month of study day 1.

8. History of use, within one month of study day 1, of any FDA-authorized treatment forCOVID-19. Use of non-approved putative therapies for COVID-19 (hyroxycholorquine,ivermectin, azithromycin) must be discontinued prior to enrollment in the study.

9. History of any systemic antiviral therapies within one month of study day 1.

10. History of oral or parenteral corticosteroid use within one month of study day 1.Active use of nasal or inhalable steroids is also exclusionary. Topical steroids arenot exclusionary.

11. History of any chronic medical condition that has required adjustments to the type,dose or schedule of medical treatments within one month of study day 1.

12. Requirement to use narcotic medication for analgesia.

13. History of vasomotor rhinitis with or without post-nasal drip within one month ofstudy day 1.

14. History of hypersensitivity or severe allergic reaction (e.g., anaphylaxis,generalized urticaria, angioedema, other significant reaction) to sun exposure.

15. Presence of any oral abnormality (e.g., including, but not limited to, ulcer, oralcandidiasis, oral mucositis, symptomatic gingivitis, history of frequent recurrentaphthous ulcers, burning mouth syndrome, dry mouth syndrome, a disease that canresult in xerostomia (e.g., Sjogren's syndrome), Temporomandibular Joint Syndrome,or other oral disorder that in the opinion of the investigator would interfere withdevice use and evaluation.

16. Any intra-oral metal body piercings that cannot be removed for the duration of thestudy. Metal orthodontia is permitted as braces will be covered by the devicemouthpiece.

17. Any individual without teeth or with a dental malformation that precludes directeduse of the device as intended.

18. Currently enrolled in or plans to participate in another clinical trial with atherapeutic investigational agent for any medical indication that will be receivedduring the study period.