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

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: Completed
• Conditions: COVID-19
• Intervention / Treatment: Device: RD-X19; Device: Sham

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 (Actual): 330
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85213
      • 322 - Desert Clinical Research/CCT Research
    • Phoenix, Arizona, United States, 85006
      • 347 - Velocity Clinical Research
  • California
    • Anaheim, California, United States, 92806
      • 312 - Smart Cures Clinical Research
    • Colton, California, United States, 92324
      • 313 - Benchmark Southern California
    • Long Beach, California, United States, 90815
      • 307 - Ark Clinical Research
    • Northridge, California, United States, 91325
      • 329 - Valley Clinical Trials
    • San Francisco, California, United States, 94127
      • 348 - San Francisco Research Institute
    • West Hollywood, California, United States, 90046
      • 328 - Mills Clinical Research
  • Florida
    • Hialeah, Florida, United States, 33012
      • 305 - Indago Research and Health Center
    • Kissimmee, Florida, United States, 34744
      • 321 - Helios Clinical Research - Kissimmee
    • Largo, Florida, United States, 33777
      • 310 - Accel Research Sites - St. Petersburg
    • Miami, Florida, United States, 33155
      • 306 - Miami Clinical Research
  • Georgia
    • Lilburn, Georgia, United States, 30047
      • 341 - Lifeline Primary Care / CCT Research
  • Illinois
    • Chicago, Illinois, United States, 60429
      • 349 - Chicago Medical Research
    • Chicago, Illinois, United States, 60462
      • 333 - Prime Global Research Inc.
    • Chicago, Illinois, United States, 60607
      • 331 - Chicago Clinical Research Institute
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • 345 - The Iowa Clinic/Avacare Legacy
  • Kentucky
    • Versailles, Kentucky, United States, 40383
      • 337 - Versailles Family Medicine/CCT Research
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • 346 - Benchmark Research
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • 323 - Annapolis Internal Medicine/CCT Research
    • Rockville, Maryland, United States, 28050
      • 324 - Advanced Primary and Geriatric Care / CCT Research
  • Massachusetts
    • Springfield, Massachusetts, United States, 01105
      • 327 - The Research Institute
  • Michigan
    • Dearborn, Michigan, United States, 48126
      • 315 - Revival Research Institute - Dearborn
    • Sterling Heights, Michigan, United States, 48312
      • 314 - Revival Research Institute - Sterling Heights
  • Mississippi
    • Olive Branch, Mississippi, United States, 38654
      • 318 - Olive Branch Family Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64151
      • 335 - Clay Platte Family Medicine/CCT Research
    • Saint Louis, Missouri, United States, 63119
      • 336 - St. Louis Medical Professional/CCT Research
  • Nebraska
    • Elkhorn, Nebraska, United States, 68022
      • 344 - Skyline Medical Center/ CCT Research
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • 326 - Healor Primary Care
    • Las Vegas, Nevada, United States, 89119
      • 325 - Santa Rosa Medical Centers of Nevada / CCT Research
  • New York
    • Bronx, New York, United States, 10456
      • 332 - Prime Global Research Inc.
    • E. Amherst, New York, United States, 14051
      • 302 - WellNow - East Amherst
    • Niskayuna, New York, United States, 12304
      • 316 - WellNow - Niskayuna
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • 338 - Carolina Internal Medicine Associates
    • Raleigh, North Carolina, United States, 27612
      • 320 - M3 Wake Research
  • Ohio
    • Cincinnati, Ohio, United States, 45215
      • 304 - WellNow - Cincinnati
    • Columbus, Ohio, United States, 43214
      • 301 - WellNow - Columbus
    • Dayton, Ohio, United States, 45424
      • 303 - WellNow - Huber Heights
  • Tennessee
    • Elizabethton, Tennessee, United States, 37643
      • 334 - Medical Care/CCT Research
    • Hendersonville, Tennessee, United States, 37075
      • 308B - Kurr Research @ Complete Health Partners
    • Nashville, Tennessee, United States, 37209
      • 308 - Kur Research @Complete Health Partners
  • Texas
    • Houston, Texas, United States, 77074
      • 330 - Clinical Trial Network
    • Keller, Texas, United States, 76248
      • 319 - Helios Clinical Research - Keller
    • Webster, Texas, United States, 77598
      • 309 - Tranquility Clinical Research
  • Utah
    • American Fork, Utah, United States, 84003
      • 340 - Premier Family Medical/CCT Research
    • Bountiful, Utah, United States, 84010
      • 343 - Cope Family Medicine/ CCT Research
    • Roy, Utah, United States, 84067
      • 342 - Ogden Clinical, Grand View/CCT Research
    • Salt Lake City, Utah, United States, 84117
      • 339 - Olympus Family Medicine/CCT

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
Active Comparator: Active; RD-X19 Active Device Investigational device that uses 32 J/cm2 of electromagnetic energy to target the oropharynx.	Device: RD-X19; Investigational device that uses safe electromagnetic energy to target the oropharynx.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Sustained Resolution of COVID-19 Signs and Symptoms Without Subsequent Symptom Recurrence or Disease Progression (Until the End of the Study)	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 that are hospitalized will be censored at 360 hours, which corresponds to the end of the time window for the day 14. A subject not satisfying case (i) or (ii), who takes nirmatrelvir/ritonavir or molnupiravir after initiating study treatment will be censored at the time that they first took this antiviral medication. Subjects not satisfying case (i), (ii), or (iii) will be censored at the last time that they have e-diary data recorded.	Baseline through Day 14
Kaplan-Meier Estimates for Time to Sustained Resolution of COVID-19 Signs and Symptoms Without Subsequent Symptom Recurrence or Disease Progression (Until the End of the Study) Full Analysis Set (FAS)	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 that are hospitalized will be censored at 360 hours, which corresponds to the end of the time window for the day 14 visit. A subject not satisfying case (i) or (ii), who takes nirmatrelvir/ritonavir or molnupiravir after initiating study treatment will be censored at the time that they first took this antiviral medication. Subjects not satisfying case (i), (ii), or (iii) will be censored at the last time that they have e-diary data recorded.	Baseline through Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Two Negative SARS-CoV-2 Antigen Tests (With a Minimum Time Between Tests of Six Hours) Without Subsequent Virological Rebound During the Subject's Remaining Time on Study	Number of subjects with two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound during the subject's remaining time on study. Subjects that are hospitalized will be censored at 360 hours, which corresponds to the end of the time window for the day 14 visit. A subject not satisfying case (i) or (ii), who takes nirmatrelvir/ritonavir or molnupiravir after initiating study treatment will be censored at the time that they first took this antiviral medication. Subjects not satisfying case (i), (ii), or (iii) will be censored at the last time that they have e-diary data recorded	Baseline through Day 14
Kaplan-Meier Estimates Time to First of Two Negative SARS-CoV-2 Antigen Tests	time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virologic rebound (during the subject's remaining time on study) Full Analysis Set (FAS)	Baseline through Day 14

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)	The following are secondary qualitative measures (each taking the values yes, no) recorded at the post-baseline clinic visits for COVID-related assessment: In the past 24 hours, have you returned to your usual health (before your COVID-19 illness)? In the past 24 hours, have you returned to your usual activities (before your COVID-19 illness)?	Baseline, Day 5, Day 8, and Day 14 or Early Termination Visit

Collaborators and Investigators

• Sponsor: EmitBio Inc.
• Investigators: Study Director: Study Director EB-P30-01, EmitBio

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2023
• Primary Completion (Actual): June 15, 2024
• Study Completion (Actual): June 30, 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): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• 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