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

March 11, 2024 updated by: EmitBio Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, sham controlled, stratified, pivotal efficacy and safety study of the EmitBio RD-X19 device in individuals age 40 and older with mild COVID-19 (as defined by NIH and FDA) in the at-home setting. Study subjects will self-administer treatment twice daily, 5 minutes per treatment for 7 consecutive days. Subjects will remain on study for a total of 14 study days (± 2 days) for treatment and follow-up. Neither study subject nor clinical trial personnel will be aware of the subject's treatment assignment. Clinical safety and efficacy outcomes will be assessed via self-assessed signs and symptoms (e-diary entries twice a day during the entire study period) with daily study staff checks, including home visits, and/or clinic visits for objective clinical assessments (vital signs, targeted physical exams, oropharyngeal exams) on study days 1, 5, 8 and 14.

The primary goal of the study is to evaluate the safety and efficacy of the RD-X19 treatment device to provide sufficient evidence to FDA to justify the authorization and/or approval of the device for treatment of subjects with mild COVID-19, age 40 and older in the home setting. Every attempt will be made to continue to follow safety in any study subject choosing to terminate the study early and all study subjects who progress to moderate or more severe forms of COVID-19 will be immediately referred for appropriate medical care. Medically necessary care of study participants will always take precedence over research.

Study Type

Interventional

Enrollment (Estimated)

326

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Study Director EB-P30-01
  • Phone Number: 919.321.1734
  • Email: info@emitbio.com

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85213
        • Recruiting
        • 322 - Desert Clinical Research/CCT Research
        • Contact:
        • Principal Investigator:
          • David Shockey, MD
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • 347 - Velocity Clinical Research
        • Contact:
          • Wendy Barrett
          • Phone Number: 602-368-1928
        • Principal Investigator:
          • Jeffrey Zacher, MD
    • California
      • Anaheim, California, United States, 92806
        • Recruiting
        • 312 - Smart Cures Clinical Research
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nadar Sobh, MD
      • Colton, California, United States, 92324
      • Long Beach, California, United States, 90815
      • Northridge, California, United States, 91325
        • Recruiting
        • 329 - Valley Clinical Trials
        • Contact:
        • Principal Investigator:
          • Massoud Azizad, MD
      • San Francisco, California, United States, 94127
        • Recruiting
        • 348 - San Francisco Research Institute
        • Contact:
          • Moazama Gul
          • Phone Number: 415-769-4102
        • Principal Investigator:
          • Mark Savant, MD
      • West Hollywood, California, United States, 90046
    • Florida
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • 305 - Indago Research and Health Center
        • Contact:
        • Principal Investigator:
          • Jose Cardona, MD
      • Kissimmee, Florida, United States, 34744
      • Largo, Florida, United States, 33777
        • Terminated
        • 310 - Accel Research Sites - St. Petersburg
      • Miami, Florida, United States, 33155
    • Georgia
      • Lilburn, Georgia, United States, 30047
        • Recruiting
        • 341 - Lifeline Primary Care / CCT Research
        • Contact:
        • Principal Investigator:
          • Aziz Pirani, MD
    • Illinois
      • Chicago, Illinois, United States, 60429
        • Terminated
        • 349 - Chicago Medical Research
      • Chicago, Illinois, United States, 60462
        • Terminated
        • 333 - Prime Global Research Inc.
      • Chicago, Illinois, United States, 60607
        • Terminated
        • 331 - Chicago Clinical Research Institute
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • 345 - The Iowa Clinic/Avacare Legacy
        • Contact:
        • Principal Investigator:
          • Lena R Freese, MD
    • Kentucky
      • Versailles, Kentucky, United States, 40383
        • Recruiting
        • 337 - Versailles Family Medicine/CCT Research
        • Principal Investigator:
          • Brian Smith, MD
        • Contact:
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Terminated
        • 346 - Benchmark Research
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Recruiting
        • 323 - Annapolis Internal Medicine/CCT Research
        • Principal Investigator:
          • Titus Abraham, MD
        • Contact:
      • Rockville, Maryland, United States, 28050
        • Recruiting
        • 324 - Advanced Primary and Geriatric Care / CCT Research
        • Principal Investigator:
          • Ravi Passi, MD
        • Contact:
    • Massachusetts
      • Springfield, Massachusetts, United States, 01105
        • Terminated
        • 327 - The Research Institute
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Recruiting
        • 315 - Revival Research Institute - Dearborn
        • Principal Investigator:
          • Abdulhassan Saad, MD
        • Contact:
      • Sterling Heights, Michigan, United States, 48312
        • Terminated
        • 314 - Revival Research Institute - Sterling Heights
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • Recruiting
        • 318 - Olive Branch Family Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Randall Huling, MD
    • Missouri
      • Kansas City, Missouri, United States, 64151
        • Recruiting
        • 335 - Clay Platte Family Medicine/CCT Research
        • Contact:
        • Principal Investigator:
          • Scott Kuennen, MD
      • Saint Louis, Missouri, United States, 63119
        • Recruiting
        • 336 - St. Louis Medical Professional/CCT Research
        • Principal Investigator:
          • Hany Salama, MD
        • Contact:
    • Nebraska
      • Elkhorn, Nebraska, United States, 68022
        • Recruiting
        • 344 - Skyline Medical Center/ CCT Research
        • Principal Investigator:
          • William Fitzgibbons, MD
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • 326 - Healor Primary Care
        • Contact:
        • Principal Investigator:
          • Raj Singh, MD
      • Las Vegas, Nevada, United States, 89119
        • Recruiting
        • 325 - Santa Rosa Medical Centers of Nevada / CCT Research
        • Contact:
        • Principal Investigator:
          • Syed Pervaiz, MD
    • New York
      • Bronx, New York, United States, 10456
        • Recruiting
        • 332 - Prime Global Research Inc.
        • Principal Investigator:
          • Rubaba Hussain, MD
        • Contact:
      • E. Amherst, New York, United States, 14051
        • Recruiting
        • 302 - WellNow - East Amherst
        • Contact:
        • Principal Investigator:
          • Jeanne Lomas, MD
      • Niskayuna, New York, United States, 12304
        • Recruiting
        • 316 - WellNow - Niskayuna
        • Contact:
        • Principal Investigator:
          • Gilbert Jenouri, MD
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Recruiting
        • 338 - Carolina Internal Medicine Associates
        • Contact:
        • Principal Investigator:
          • Pam Cavanaugh, MD
      • Raleigh, North Carolina, United States, 27612
        • Recruiting
        • 320 - M3 Wake Research
        • Contact:
        • Principal Investigator:
          • Robert McGarrah, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45215
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • 301 - WellNow - Columbus
        • Principal Investigator:
          • Steve Choi, MD
        • Contact:
      • Dayton, Ohio, United States, 45424
    • Tennessee
      • Elizabethton, Tennessee, United States, 37643
        • Recruiting
        • 334 - Medical Care/CCT Research
        • Contact:
        • Principal Investigator:
          • Jeff Hopland, MD
      • Hendersonville, Tennessee, United States, 37075
        • Terminated
        • 308B - Kurr Research @ Complete Health Partners
      • Nashville, Tennessee, United States, 37209
        • Terminated
        • 308 - Kur Research @Complete Health Partners
    • Texas
      • Houston, Texas, United States, 77074
        • Recruiting
        • 330 - Clinical Trial Network
        • Contact:
        • Principal Investigator:
          • Maxwell Axler, MD
      • Keller, Texas, United States, 76248
      • Webster, Texas, United States, 77598
        • Recruiting
        • 309 - Tranquility Clinical Research
        • Contact:
        • Principal Investigator:
          • Joe Pouzar, MD
    • Utah
      • American Fork, Utah, United States, 84003
        • Recruiting
        • 340 - Premier Family Medical/CCT Research
        • Contact:
        • Principal Investigator:
          • Joshua Hardman, MD
      • Bountiful, Utah, United States, 84010
        • Terminated
        • 343 - Cope Family Medicine/ CCT Research
      • Roy, Utah, United States, 84067
        • Recruiting
        • 342 - Ogden Clinical, Grand View/CCT Research
        • Contact:
        • Principal Investigator:
          • Kelly Amann, MD
      • Salt Lake City, Utah, United States, 84117
        • Terminated
        • 339 - Olympus Family Medicine/CCT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Positive for SARS-CoV-2 as detected using an FDA authorized SARS-CoV-2 antigen test at the screening/baseline visit.
  2. Negative for Influenza A and B antigen using an FDA-authorized rapid diagnostic test.
  3. At least two moderate or greater COVID-19 signs and symptoms from the following list: cough, sore throat, nasal congestion, headache, chills and/or sweats, myalgia, fatigue, nausea (with or without vomiting) or one moderate or greater symptom and fever (temperature ≥ 100.5 degrees F).
  4. Time from appearance of first COVID-19 sign or symptom to screening must be 72 hours or less.
  5. Males or females, including pregnant and fecund females, 40 years of age and older on the date of enrollment.
  6. BMI <40
  7. Provides written informed consent prior to initiation of any study procedures.
  8. Be able to understand and agrees to fully comply with defined and described study procedures and be available for all study visits for the entire study duration.
  9. Agrees to collection of a nasopharyngeal swab for qPCR at baseline for the purposes of assessing viral burden as a potential covariate in data analyses and for genetic sequencing to characterize the predominant SARS-CoV-2 variants present in the study population.
  10. Agrees to perform self-diagnostic home testing twice a day, separated by ≥ 6 hours for the entire length of the study.
  11. Agrees to restrict medications used for symptomatic relief of signs and symptoms of COVID-19 during the study period, and, if used, to report ALL such medications (including home remedies) to the study staff.
  12. Agrees to avoid the use of oral rinses and toothpastes containing alcohol-based compounds (e.g. Eucalyptol, Menthol, Thymol, Phenol) and/or Salicylates during the study period. Oral rinses, breath fresheners and toothpaste not containing these compounds are allowed.
  13. Agrees to avoid nasal and sinus saline lavage during the study period.
  14. No uncontrolled disease process (chronic or acute), other than COVID-19 signs and symptoms (See section 8.1.1 - General Screening)*.
  15. No physical or mental conditions or attributes at the time of screening, which in the opinion of the PI, will prevent full adherence to, and completion of, the protocol.

Exclusion Criteria:

  1. Positive for Influenza A and B antigen using an FDA-authorized rapid diagnostic test.
  2. Individuals < age 40 on study day 1.
  3. Individuals who are symptomatic for COVID-19 for more than 72 hours on study day 1.
  4. COVID-19 signs associated with moderate or greater disease with evidence of lower respiratory involvement including shortness of breath (SOB) at rest or as determined by an exertional SOB protocol, SpO2 ≤94, respiratory rate ≥20 breaths per minute, heart rate ≥90 beats per minute, or abnormal pulmonary imaging.
  5. Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
  6. History of use of a rescue inhaler for uncontrolled asthma within one month of study day 1.
  7. History of recurrent alcohol intoxication or other recreational drug use (excluding medically prescribed cannabis) within one month of study day 1.
  8. History of use, within one month of study day 1, of any FDA-authorized treatment for COVID-19. Use of non-approved putative therapies for COVID-19 (hyroxycholorquine, ivermectin, azithromycin) must be discontinued prior to enrollment in the study.
  9. History of any systemic antiviral therapies within one month of study day 1.
  10. History of oral or parenteral corticosteroid use within one month of study day 1. Active use of nasal or inhalable steroids is also exclusionary. Topical steroids are not exclusionary.
  11. History of any chronic medical condition that has required adjustments to the type, dose or schedule of medical treatments within one month of study day 1.
  12. Requirement to use narcotic medication for analgesia.
  13. History of vasomotor rhinitis with or without post-nasal drip within one month of study day 1.
  14. History of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to sun exposure.
  15. Presence of any oral abnormality (e.g., including, but not limited to, ulcer, oral candidiasis, oral mucositis, symptomatic gingivitis, history of frequent recurrent aphthous ulcers, burning mouth syndrome, dry mouth syndrome, a disease that can result in xerostomia (e.g., Sjogren's syndrome), Temporomandibular Joint Syndrome, or other oral disorder that in the opinion of the investigator would interfere with device use and evaluation.
  16. Any intra-oral metal body piercings that cannot be removed for the duration of the study. Metal orthodontia is permitted as braces will be covered by the device mouthpiece.
  17. Any individual without teeth or with a dental malformation that precludes directed use of the device as intended.
  18. Currently enrolled in or plans to participate in another clinical trial with a therapeutic investigational agent for any medical indication that will be received during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active

RD-X19 Active Device

Investigational device that uses safe electromagnetic energy to target the oropharynx.
Device: RD-X19
Investigational device that uses safe electromagnetic energy to target the oropharynx.
Sham Comparator: Sham

RD-X19 Sham Device

Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV2 in vitro.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained resolution of COVID-19 signs and symptoms
Time Frame: Baseline through Day 14
Time to sustained resolution of COVID-19 signs and symptoms without subsequent symptom recurrence or disease progression until the end of the study.
Baseline through Day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first of two consecutive negative antigen tests
Time Frame: Baseline through Day 14
[Key] Time to the first of two consecutive negative SARS-CoV-2 antigen tests without subsequent virological rebound.
Baseline through Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EmitBio Inc.

Investigators

  • Study Director: Study Director EB-P30-01, EmitBio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

August 15, 2024

Study Registration Dates

First Submitted

April 14, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EB-P30-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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