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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05817045
• Other study ID #: EB-P30-01
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2023
• Est. completion date: August 15, 2024

Study information

• Verified date: March 2024
• Source: KNOWBio Inc.
• Contact: Study Director EB-P30-01
• Phone: 919.321.1734
• Email: info[@]emitbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 326
• Est. completion date: August 15, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
United States	340 - Premier Family Medical/CCT Research	American Fork	Utah
United States	312 - Smart Cures Clinical Research	Anaheim	California
United States	323 - Annapolis Internal Medicine/CCT Research	Annapolis	Maryland
United States	338 - Carolina Internal Medicine Associates	Asheville	North Carolina
United States	343 - Cope Family Medicine/ CCT Research	Bountiful	Utah
United States	332 - Prime Global Research Inc.	Bronx	New York
United States	331 - Chicago Clinical Research Institute	Chicago	Illinois
United States	333 - Prime Global Research Inc.	Chicago	Illinois
United States	349 - Chicago Medical Research	Chicago	Illinois
United States	304 - WellNow - Cincinnati	Cincinnati	Ohio
United States	313 - Benchmark Southern California	Colton	California
United States	301 - WellNow - Columbus	Columbus	Ohio
United States	303 - WellNow - Huber Heights	Dayton	Ohio
United States	315 - Revival Research Institute - Dearborn	Dearborn	Michigan
United States	302 - WellNow - East Amherst	E. Amherst	New York
United States	334 - Medical Care/CCT Research	Elizabethton	Tennessee
United States	344 - Skyline Medical Center/ CCT Research	Elkhorn	Nebraska
United States	308B - Kurr Research @ Complete Health Partners	Hendersonville	Tennessee
United States	305 - Indago Research and Health Center	Hialeah	Florida
United States	330 - Clinical Trial Network	Houston	Texas
United States	335 - Clay Platte Family Medicine/CCT Research	Kansas City	Missouri
United States	319 - Helios Clinical Research - Keller	Keller	Texas
United States	321 - Helios Clinical Research - Kissimmee	Kissimmee	Florida
United States	310 - Accel Research Sites - St. Petersburg	Largo	Florida
United States	325 - Santa Rosa Medical Centers of Nevada / CCT Research	Las Vegas	Nevada
United States	326 - Healor Primary Care	Las Vegas	Nevada
United States	341 - Lifeline Primary Care / CCT Research	Lilburn	Georgia
United States	307 - Ark Clinical Research	Long Beach	California
United States	322 - Desert Clinical Research/CCT Research	Mesa	Arizona
United States	346 - Benchmark Research	Metairie	Louisiana
United States	306 - Miami Clinical Research	Miami	Florida
United States	308 - Kur Research @Complete Health Partners	Nashville	Tennessee
United States	316 - WellNow - Niskayuna	Niskayuna	New York
United States	329 - Valley Clinical Trials	Northridge	California
United States	318 - Olive Branch Family Medical Center	Olive Branch	Mississippi
United States	347 - Velocity Clinical Research	Phoenix	Arizona
United States	320 - M3 Wake Research	Raleigh	North Carolina
United States	324 - Advanced Primary and Geriatric Care / CCT Research	Rockville	Maryland
United States	342 - Ogden Clinical, Grand View/CCT Research	Roy	Utah
United States	336 - St. Louis Medical Professional/CCT Research	Saint Louis	Missouri
United States	339 - Olympus Family Medicine/CCT	Salt Lake City	Utah
United States	348 - San Francisco Research Institute	San Francisco	California
United States	327 - The Research Institute	Springfield	Massachusetts
United States	314 - Revival Research Institute - Sterling Heights	Sterling Heights	Michigan
United States	337 - Versailles Family Medicine/CCT Research	Versailles	Kentucky
United States	309 - Tranquility Clinical Research	Webster	Texas
United States	345 - The Iowa Clinic/Avacare Legacy	West Des Moines	Iowa
United States	328 - Mills Clinical Research	West Hollywood	California

Sponsors (1)

Lead Sponsor	Collaborator
EmitBio Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained resolution of COVID-19 signs and symptoms	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	Time to first of two consecutive negative antigen tests	[Key] Time to the first of two consecutive negative SARS-CoV-2 antigen tests without subsequent virological rebound.	Baseline through Day 14