Evaluation of the RD-X19 Treatment Device in Individuals With Mild to Moderate COVID-19
Condition: COVID19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      This is a randomized, sham controlled, dose finding study of the EmitBio RD-X19 device in
      individuals with symptomatic COVID-19 in the outpatient setting.
    

Detailed description: 
      This is a randomized, sham controlled, dose finding study of the EmitBio RD-X19 device in
      individuals with symptomatic COVID-19 in the outpatient setting. Study subjects will
      self-administer treatment twice daily for 7 days with a one-week follow-up period at Day 14
      (+/- 2 days) and will not be aware of which treatment group to which they have been
      randomized. Clinical outcomes will be assessed via patient reported outcomes (questionnaire
      and diary cards) and virologic outcomes will be assessed post baseline on Days 3, 5, 8, and
      14 via biospecimen collection.

      The primary goal of the study is to evaluate multiple doses of the RD-X19 treatment device
      and establish evidence for safety and efficacy for each of the RD-X19 doses compared to sham
      in SARS-CoV-2 infected individuals with outpatient COVID-19. The primary efficacy outcome is
      time to sustained symptom resolution. Other clinical and microbiological outcomes will also
      be assessed.

      Safety and tolerability (local reactogenicity) will be assessed actively and study subject
      diary card data recorded at each clinic visit by review of potential treatment emergent
      adverse events (TEAEs) and targeted oral and physical examinations. Volunteers will be
      instructed to contact designated clinical trial staff for AEs of a medically-urgent nature as
      soon as is practically possible and to seek immediate medical care, if needed. Study subjects
      who experience progression of disease to a grade 3 severity score (e.g SpO2 ≤ 93%, or
      respiratory rate ≥30/ minute on room air) will be instructed to urgently seek medical care at
      their nearest Urgent Care or Emergency Department. Study subjects who progress to severe
      acute respiratory distress syndrome with substantial risk for mortality without immediate
      medical intervention will be referred directly by site staff to their closest hospital. All
      study subjects who are hospitalized will be tracked to assess time to hospital discharge or
      death; the time and date of these events will be captured as part of the trial data.

      Metabolic, liver, kidney and hematological laboratory evaluations will be performed at
      baseline and at Day 14 or early termination (and potentially during unscheduled) clinic
      visits. Methemoglobin assessments will be performed at baseline and Day 14.
    

Intervention name(s): RD-X19; Sham
Intervention type(s): Device; Device
Intervention description(s): Investigational device that uses safe electromagnetic energy to target the oropharynx.; Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro..
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Volunteers meeting all inclusion criteria and none of the exclusion criteria will be randomized to the RD-X19 treatment arm or the sham treatment arm within each cohort in a 2:1 ratio according to a fixed schedule via a permuted block design.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment