NCT04662671

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

Phase I/II Randomized, Dose Escalation Study to Evaluate the Safety and Antiviral Activity of the RD-X19 Device in SARS-CoV-2 Infected Individuals With Uncomplicated COVID-19

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: EmitBio Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This randomized, Phase I/II feasibility study will evaluate the safety and efficacy of the RD-X19 device in SARS-CoV-2 infected individuals with uncomplicated COVID-19.

Detailed description

This is a randomized, sham-controlled dose escalation and bioeffect study. The primary goal of the study is to evaluate the safety of the RD-X19 device in SARS-CoV-2 infected individuals with outpatient COVID-19 and to assess the reduction of SARS-CoV-2 viral load in each dose group compared to sham controls. The primary safety measure is absence of device-related serious adverse events or patterns of severity ≥2 device-related adverse events. Safety and tolerability (local reactogenicity) will be assessed actively on each clinic visit by review of potential adverse events (AEs) and targeted physical examination, as required. Metabolic, liver, kidney and hematological laboratory evaluations will be performed at baseline and at Day 8 or early termination (and potentially during unscheduled) clinic visits. Methemoglobin assessments will be performed at baseline and Day 8. Various efficacy assessments will explore the impact of RD-X19 treatment on the reduction in log10 SARS-CoV-2 viral load and alleviation of symptoms associated with COVID-19. Both the magnitude of reduction as a function of dose as well as time to clearance will be assessed.

Conditions

• COVID19

Interventions

Type	Name	Description
DEVICE	RD-X19	Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens.

Timeline

• Start date: 2020-11-18
• Primary completion: 2020-12-09
• Completion: 2021-01-30
• First posted: 2020-12-10
• Last updated: 2022-09-08
• Results posted: 2022-09-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study