Evaluation of the RD-X19 Treatment Device in Individuals With Mild to Moderate COVID-19
- Conditions
- COVID19
- Interventions
- Device: RD-X19Device: Sham
- Registration Number
- NCT04966013
- Lead Sponsor
- EmitBio Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 216
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description RD-X19 Device, Dose A RD-X19 RD-X19. Investigational device that delivers 24 J/cm2 of electromagnetic energy to the oropharynx. RD-X19 Device, Dose B RD-X19 RD-X19. Investigational device that delivers 32 J/cm2 of electromagnetic energy to the oropharynx. Sham Device Sham 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.
- Primary Outcome Measures
Name Time Method Time to Sustained Resolution of COVID-19 Signs and Symptoms in All Subjects (With Mild or Moderate Disease at Baseline). Baseline thru Day 14 Each of eight symptoms (cough, sore throat, nasal congestion, headache, chills and or sweats, myalgia, fatigue, and nausea (with or without vomiting)) will be rated on a 4-point scale from none (0) to severe (3). Time to sustained resolution of COVID-19 signs and symptoms as measured by the time (in hours) when all eight symptoms have been assessed by the subject as none (0) or mild (1) and all symptoms remain at or below 1 until study Day 14. Subjects reporting a persistent fever (100.5 degrees for 36 hours or more) and/or SpO2 levels \<96% with any shortness of breath are considered not to have met the success criterion on that day even if all other symptoms are reported as none (0) or mild (1).
Sustained Resolution of COVID-19 Signs and Symptoms in Subjects With Mild Disease at Baseline. Baseline thru Day 14 Each of eight symptoms (cough, sore throat, nasal congestion, headache, chills and or sweats, myalgia, fatigue, and nausea (with or without vomiting)) will be rated on a 4-point scale from none (0) to severe (3). Time to sustained resolution of COVID-19 signs and symptoms as measured by the time (in hours) when all eight symptoms have been assessed by the subject as none (0) or mild (1) and all symptoms remain at or below 1 until study Day 14. Subjects reporting a persistent fever (100.5 degrees for 36 hours or more) and/or SpO2 levels \<96% with any shortness of breath are considered not to have met the success criterion on that day even if all other symptoms are reported as none (0) or mild (1).
- Secondary Outcome Measures
Name Time Method Medically Attended Visits Baseline thru Day 14 Numbers and percentages of study subjects who require medical attention or intervention attributed to COVID-19;
Severe Disease Progression Baseline thru Day 14 Numbers and percentages of study subjects who progress to severe disease with respiratory rate \>30/minute and/or O2 saturation \</=93% on room air or FiO2 ≥300% with any respiratory distress.
Hospitalizations Baseline thru Day 14 Numbers and percentages of study subjects who require hospitalization for severe COVID-19.
Worsening of Disease Day 3 thru Day 14 Number and percentage of study subjects who experience progression of COVID-19 as defined by an increase of the composite COVID-19 severity score greater than baseline at any point in the study on or after day 3.
Return to Pre-COVID Health Days 8 and 14 Numbers and percentages of study subjects on day 8 and day 14 who answer yes to the following patient-reported global impression assessments, a) return to usual health and b) return to usual activities.
1. In the past 24 hours, have you returned to your usual health (before your COVID-19 illness)? Yes or No
2. In the past 24 hours, have you returned to your usual activities (before your COVID-19 illness)? Yes or No
Note: subjects with missing Data at Day 8 or Day 14 were not included in total subjects analyzedMean Change in Nasopharyngeal Viral Load Days 3, 5, 8 and 14 Mean change in nasopharyngeal viral load from baseline on days 3, 5, 8, and 14.
Proportion of Subjects Demonstrating Clearance of Viral Infection Days 3, 5, 8 and 14 Proportion of subjects demonstrating clearance of viral infection on Days 3, 5, 8 and 14.
Day 8 Composite Resolution Baseline thru Day 8 Proportion of study subjects who achieve Day 8 Composite Resolution.
Endotracheal Ventilation or ECMO Baseline thru Day 14 Number and percentage of study subjects who require endotracheal ventilation or ECMO with or without the use of solumedrol.
Death Baseline thru Day 14 Number and percentage of study subjects who die.
Trial Locations
- Locations (9)
Site 2 - Innovative Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
Site 1 - APF Research LLC
🇺🇸Miami, Florida, United States
Site 8 - WellNow Urgent Care
🇺🇸Kalamazoo, Michigan, United States
Site 9 - Revival Research Institute, LLC
🇺🇸Sterling Heights, Michigan, United States
Site 4 - Peters Medical Research
🇺🇸High Point, North Carolina, United States
Site 7 - WellNow Urgent Care
🇺🇸Cincinnati, Ohio, United States
Site 5 - WellNow Urgent Care
🇺🇸Columbus, Ohio, United States
Site 6 - WellNow Urgent Care
🇺🇸Dayton, Ohio, United States
Site 3 - J&S Studies, Inc.
🇺🇸College Station, Texas, United States