Phase I/II Safety, Dose Finding & Antiviral Activity of RD-X19 in Mild/Moderate Outpatient COVID-19

Inclusion Criteria

• Positive for SARS-CoV-2 antigen via nasal swab at or within the past 24 hours of the screening visit detected using an FDA authorized SARS-CoV-2 antigen test.
• Onset of signs and symptoms consistent with COVID-19* no longer than within the past 3 days* and have either a) a fever of at least 100 °F or b) at least two moderate or severe symptoms (cough, sore throat, nasal congestion, headache, chills/sweats, muscle or joint pain, fatigue, and nausea) at the time of screening.
• Provides written informed consent prior to initiation of any study procedures.
• Be able to understand and agrees to comply with planned study procedures and be available for all study visits.
• Agrees to the collection of nasopharyngeal swabs, oropharyngeal swabs, oral saliva specimen collection and venous blood specimens per protocol.
• Agrees to refrain from using oral antiseptics (e.g. hydrogen peroxide rinse, Listerine) or mouthwashes of any kind during the study.
• Male or non-pregnant female, 18 to 65 years of age, inclusive, at time of enrollment.
• No uncontrolled disease process (chronic or acute), other than COVID-19 signs and symptoms*.
• No physical or mental conditions or attributes at the time of screening, which in the opinion of the PI, will prevent full adherence to, and completion of, the protocol.

Exclusion Criteria

• Positive urine pregnancy test at screening.
• Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
• Presence of self-reported or medically documented uncontrolled significant medical or psychiatric condition(s) other than COVID-19.
• Reports a recent positive test result (within the past 6 months) for hepatitis B surface antigen, hepatitis C virus antibody, or HIV-1 antibodies at screening.
• Has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 1 month of Study Day 1.
• COVID-19 signs associated with acute respiratory distress or imminent serious medical outcomes. ^^
• BMI ≥36
• Subjects living (e.g., siblings, spouses, relatives, roommates) in the same household cannot be enrolled.
• Has participated in another investigational study involving any intervention for SARS-CoV-2/COVID- 19 within the past 6 months or any clinical trial with interventional investigational product within 30 days of screening.
• Currently enrolled in or plans to participate in another clinical trial with an interventional investigational agent that will be received during the studyperiod.
• History of hospitalization within the past 60 days.
• History of systemic antiviral therapies within the past 30 days.
• History of oral corticoid steroid use within the past 14 days or steroid injection within the past 6 months. Active use of nasal or inhalable steroids is also exclusionary. Topical steroids are not exclusionary.
• Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to nitrites, nitrates, or sun exposure.
• Has any oral abnormality (e.g. ulcer, oral mucositis, gingivitis) that in the opinion of the investigator would interfere with device use, or intra-oral metal body piercings that cannot be removed for the duration of the study. Metal orthodontia is permitted as braces will be covered by the device mouthpiece.