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

Inclusion Criteria

• Positive for SARS-CoV-2 as detected using an FDA authorized SARS-CoV-2 antigen test at the screening/baseline visit.
• Negative for Influenza A and B antigen using an FDA-authorized rapid diagnostic test.
• At least two moderate or greater COVID-19 signs and symptoms from the following list: cough, sore throat, nasal congestion, headache, chills and/or sweats, myalgia, fatigue, nausea (with or without vomiting) or one moderate or greater symptom and fever (temperature ≥ 100.5 degrees F).
• Time from appearance of first COVID-19 sign or symptom to screening must be 72 hours or less.
• Males or females, including pregnant and fecund females, 40 years of age and older on the date of enrollment.
• BMI <40
• Provides written informed consent prior to initiation of any study procedures.
• Be able to understand and agrees to fully comply with defined and described study procedures and be available for all study visits for the entire study duration.
• Agrees to collection of a nasopharyngeal swab for qPCR at baseline for the purposes of assessing viral burden as a potential covariate in data analyses and for genetic sequencing to characterize the predominant SARS-CoV-2 variants present in the study population.
• Agrees to perform self-diagnostic home testing twice a day, separated by ≥ 6 hours for the entire length of the study.
• Agrees to restrict medications used for symptomatic relief of signs and symptoms of COVID-19 during the study period, and, if used, to report ALL such medications (including home remedies) to the study staff.
• Agrees to avoid the use of oral rinses and toothpastes containing alcohol-based compounds (e.g. Eucalyptol, Menthol, Thymol, Phenol) and/or Salicylates during the study period. Oral rinses, breath fresheners and toothpaste not containing these compounds are allowed.
• Agrees to avoid nasal and sinus saline lavage during the study period.
• No uncontrolled disease process (chronic or acute), other than COVID-19 signs and symptoms (See section 8.1.1 - General Screening)*.
• 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 for Influenza A and B antigen using an FDA-authorized rapid diagnostic test.
• Individuals < age 40 on study day 1.
• Individuals who are symptomatic for COVID-19 for more than 72 hours on study day 1.
• COVID-19 signs associated with moderate or greater disease with evidence of lower respiratory involvement including shortness of breath (SOB) at rest or as determined by an exertional SOB protocol, SpO2 ≤94, respiratory rate ≥20 breaths per minute, heart rate ≥90 beats per minute, or abnormal pulmonary imaging.
• Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
• History of use of a rescue inhaler for uncontrolled asthma within one month of study day 1.
• History of recurrent alcohol intoxication or other recreational drug use (excluding medically prescribed cannabis) within one month of study day 1.
• History of use, within one month of study day 1, of any FDA-authorized treatment for COVID-19. Use of non-approved putative therapies for COVID-19 (hyroxycholorquine, ivermectin, azithromycin) must be discontinued prior to enrollment in the study.
• History of any systemic antiviral therapies within one month of study day 1.
• 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 are not exclusionary.
• 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.
• Requirement to use narcotic medication for analgesia.
• History of vasomotor rhinitis with or without post