MedTrace Logo

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

NCT05817045 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2024-10-24

Study results available
· View outcomes & findings →

Summary

This is a randomized, double-blind, sham controlled, stratified, pivotal efficacy and safety study of the EmitBio RD-X19 treatment device in Individuals 40 Years of age and older with Mild COVID-19 in the at-home setting.

Conditions

Interventions

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.

Sponsors & Collaborators

  • EmitBio Inc.

    lead INDUSTRY

Principal Investigators

  • Study Director EB-P30-01 · EmitBio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-21
Primary Completion
2024-06-15
Completion
2024-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05817045 on ClinicalTrials.gov