NCT04966013

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

A Phase II, Randomized, Sham Controlled Dose Finding Study of the RD-X19 Treatment Device in Individuals With Mild to Moderate COVID-19

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: EmitBio Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID19

Interventions

Type	Name	Description
DEVICE	RD-X19	Investigational device that uses safe electromagnetic energy to target the oropharynx.
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..

Timeline

• Start date: 2021-06-17
• Primary completion: 2022-01-05
• Completion: 2022-02-23
• First posted: 2021-07-19
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study