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

NCT ID: NCT05817045

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-21
• Study Completion Date: 2024-06-30

Brief 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.

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active

RD-X19 Active Device

Investigational device that uses 32 J/cm2 of electromagnetic energy to target the oropharynx.

Group Type: ACTIVE_COMPARATOR

RD-X19

Intervention Type: DEVICE

Investigational device that uses safe electromagnetic energy to target the oropharynx.

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.

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

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.

Interventions

RD-X19

Investigational device that uses safe electromagnetic energy to target the oropharynx.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EmitBio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director EB-P30-01

Role: STUDY_DIRECTOR

EmitBio

Locations

322 - Desert Clinical Research/CCT Research

Mesa, Arizona, United States

347 - Velocity Clinical Research

Phoenix, Arizona, United States

312 - Smart Cures Clinical Research

Anaheim, California, United States

313 - Benchmark Southern California

Colton, California, United States

307 - Ark Clinical Research

Long Beach, California, United States

329 - Valley Clinical Trials

Northridge, California, United States

348 - San Francisco Research Institute

San Francisco, California, United States

328 - Mills Clinical Research

West Hollywood, California, United States

305 - Indago Research and Health Center

Hialeah, Florida, United States

321 - Helios Clinical Research - Kissimmee

Kissimmee, Florida, United States

310 - Accel Research Sites - St. Petersburg

Largo, Florida, United States

306 - Miami Clinical Research

Miami, Florida, United States

341 - Lifeline Primary Care / CCT Research

Lilburn, Georgia, United States

349 - Chicago Medical Research

Chicago, Illinois, United States

333 - Prime Global Research Inc.

Chicago, Illinois, United States

331 - Chicago Clinical Research Institute

Chicago, Illinois, United States

345 - The Iowa Clinic/Avacare Legacy

West Des Moines, Iowa, United States

337 - Versailles Family Medicine/CCT Research

Versailles, Kentucky, United States

346 - Benchmark Research

Metairie, Louisiana, United States

323 - Annapolis Internal Medicine/CCT Research

Annapolis, Maryland, United States

324 - Advanced Primary and Geriatric Care / CCT Research

Rockville, Maryland, United States

327 - The Research Institute

Springfield, Massachusetts, United States

315 - Revival Research Institute - Dearborn

Dearborn, Michigan, United States

314 - Revival Research Institute - Sterling Heights

Sterling Heights, Michigan, United States

318 - Olive Branch Family Medical Center

Olive Branch, Mississippi, United States

335 - Clay Platte Family Medicine/CCT Research

Kansas City, Missouri, United States

336 - St. Louis Medical Professional/CCT Research

St Louis, Missouri, United States

344 - Skyline Medical Center/ CCT Research

Elkhorn, Nebraska, United States

326 - Healor Primary Care

Las Vegas, Nevada, United States

325 - Santa Rosa Medical Centers of Nevada / CCT Research

Las Vegas, Nevada, United States

302 - WellNow - East Amherst

East Amherst, New York, United States

316 - WellNow - Niskayuna

Niskayuna, New York, United States

332 - Prime Global Research Inc.

The Bronx, New York, United States

338 - Carolina Internal Medicine Associates

Asheville, North Carolina, United States

320 - M3 Wake Research

Raleigh, North Carolina, United States

304 - WellNow - Cincinnati

Cincinnati, Ohio, United States

301 - WellNow - Columbus

Columbus, Ohio, United States

303 - WellNow - Huber Heights

Dayton, Ohio, United States

334 - Medical Care/CCT Research

Elizabethton, Tennessee, United States

308B - Kurr Research @ Complete Health Partners

Hendersonville, Tennessee, United States

308 - Kur Research @Complete Health Partners

Nashville, Tennessee, United States

330 - Clinical Trial Network

Houston, Texas, United States

319 - Helios Clinical Research - Keller

Keller, Texas, United States

309 - Tranquility Clinical Research

Webster, Texas, United States

340 - Premier Family Medical/CCT Research

American Fork, Utah, United States

343 - Cope Family Medicine/ CCT Research

Bountiful, Utah, United States

342 - Ogden Clinical, Grand View/CCT Research

Roy, Utah, United States

339 - Olympus Family Medicine/CCT

Salt Lake City, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

EB-P30-01

Identifier Type: -

Identifier Source: org_study_id