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

NCT05817045 | Completed Results DMC FDA Device

• 1 other identifier: EB-P30-01
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 48

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

  Baseline through Day 14

• Kaplan-Meier Estimates Time to First of Two Negative SARS-CoV-2 Antigen Tests

  Baseline through Day 14

Other Outcomes (1)

• Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)

  Baseline, Day 5, Day 8, and Day 14 or Early Termination Visit

Study Arms (2)

Active

ACTIVE COMPARATOR

RD-X19 Active Device Investigational device that uses 32 J/cm2 of electromagnetic energy to target the oropharynx.

Device: RD-X19

Sham

SHAM COMPARATOR

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

Interventions

RD-X19 DEVICE

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

Active

Sham 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.

Sham

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive for SARS-CoV-2 as detected using an FDA authorized SARS-CoV-2 antigen test at the screening/baseline visit.
• Negative for Influenza A and B antigen using an FDA-authorized rapid diagnostic test.
• 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).
• Time from appearance of first COVID-19 sign or symptom to screening must be 72 hours or less.
• Males or females, including pregnant and fecund females, 40 years of age and older on the date of enrollment.
• BMI \<40
• Provides written informed consent prior to initiation of any study procedures.
• 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.
• 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.
• Agrees to perform self-diagnostic home testing twice a day, separated by ≥ 6 hours for the entire length of the study.
• 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.
• 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.
• Agrees to avoid nasal and sinus saline lavage during the study period.
• No uncontrolled disease process (chronic or acute), other than COVID-19 signs and symptoms (See section 8.1.1 - General Screening)\*.
• 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.

You may not qualify if:

• Positive for Influenza A and B antigen using an FDA-authorized rapid diagnostic test.
• Individuals \< age 40 on study day 1.
• Individuals who are symptomatic for COVID-19 for more than 72 hours on study day 1.
• 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.
• Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
• History of use of a rescue inhaler for uncontrolled asthma within one month of study day 1.
• History of recurrent alcohol intoxication or other recreational drug use (excluding medically prescribed cannabis) within one month of study day 1.
• 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.
• History of any systemic antiviral therapies within one month of study day 1.
• 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.
• Requirement to use narcotic medication for analgesia.
• History of vasomotor rhinitis with or without post-nasal drip within one month of study day 1.
• History of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to sun exposure.
• 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.
• 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.

Sponsors & Collaborators

• EmitBio Inc.: lead

Study Sites (48)

322 - Desert Clinical Research/CCT Research

Mesa, Arizona, 85213, United States

Location

347 - Velocity Clinical Research

Phoenix, Arizona, 85006, United States

Location

312 - Smart Cures Clinical Research

Anaheim, California, 92806, United States

Location

313 - Benchmark Southern California

Colton, California, 92324, United States

Location

307 - Ark Clinical Research

Long Beach, California, 90815, United States

Location

329 - Valley Clinical Trials

Northridge, California, 91325, United States

Location

348 - San Francisco Research Institute

San Francisco, California, 94127, United States

Location

328 - Mills Clinical Research

West Hollywood, California, 90046, United States

Location

305 - Indago Research and Health Center

Hialeah, Florida, 33012, United States

Location

321 - Helios Clinical Research - Kissimmee

Kissimmee, Florida, 34744, United States

Location

310 - Accel Research Sites - St. Petersburg

Largo, Florida, 33777, United States

Location

306 - Miami Clinical Research

Miami, Florida, 33155, United States

Location

341 - Lifeline Primary Care / CCT Research

Lilburn, Georgia, 30047, United States

Location

349 - Chicago Medical Research

Chicago, Illinois, 60429, United States

Location

333 - Prime Global Research Inc.

Chicago, Illinois, 60462, United States

Location

331 - Chicago Clinical Research Institute

Chicago, Illinois, 60607, United States

Location

345 - The Iowa Clinic/Avacare Legacy

West Des Moines, Iowa, 50266, United States

Location

337 - Versailles Family Medicine/CCT Research

Versailles, Kentucky, 40383, United States

Location

346 - Benchmark Research

Metairie, Louisiana, 70006, United States

Location

323 - Annapolis Internal Medicine/CCT Research

Annapolis, Maryland, 21401, United States

Location

324 - Advanced Primary and Geriatric Care / CCT Research

Rockville, Maryland, 28050, United States

Location

327 - The Research Institute

Springfield, Massachusetts, 01105, United States

Location

315 - Revival Research Institute - Dearborn

Dearborn, Michigan, 48126, United States

Location

314 - Revival Research Institute - Sterling Heights

Sterling Heights, Michigan, 48312, United States

Location

318 - Olive Branch Family Medical Center

Olive Branch, Mississippi, 38654, United States

Location

335 - Clay Platte Family Medicine/CCT Research

Kansas City, Missouri, 64151, United States

Location

336 - St. Louis Medical Professional/CCT Research

St Louis, Missouri, 63119, United States

Location

344 - Skyline Medical Center/ CCT Research

Elkhorn, Nebraska, 68022, United States

Location

326 - Healor Primary Care

Las Vegas, Nevada, 89102, United States

Location

325 - Santa Rosa Medical Centers of Nevada / CCT Research

Las Vegas, Nevada, 89119, United States

Location

302 - WellNow - East Amherst

East Amherst, New York, 14051, United States

Location

316 - WellNow - Niskayuna

Niskayuna, New York, 12304, United States

Location

332 - Prime Global Research Inc.

The Bronx, New York, 10456, United States

Location

338 - Carolina Internal Medicine Associates

Asheville, North Carolina, 28803, United States

Location

320 - M3 Wake Research

Raleigh, North Carolina, 27612, United States

Location

304 - WellNow - Cincinnati

Cincinnati, Ohio, 45215, United States

Location

301 - WellNow - Columbus

Columbus, Ohio, 43214, United States

Location

303 - WellNow - Huber Heights

Dayton, Ohio, 45424, United States

Location

334 - Medical Care/CCT Research

Elizabethton, Tennessee, 37643, United States

Location

308B - Kurr Research @ Complete Health Partners

Hendersonville, Tennessee, 37075, United States

Location

308 - Kur Research @Complete Health Partners

Nashville, Tennessee, 37209, United States

Location

330 - Clinical Trial Network

Houston, Texas, 77074, United States

Location

319 - Helios Clinical Research - Keller

Keller, Texas, 76248, United States

Location

309 - Tranquility Clinical Research

Webster, Texas, 77598, United States

Location

340 - Premier Family Medical/CCT Research

American Fork, Utah, 84003, United States

Location

343 - Cope Family Medicine/ CCT Research

Bountiful, Utah, 84010, United States

Location

342 - Ogden Clinical, Grand View/CCT Research

Roy, Utah, 84067, United States

Location

339 - Olympus Family Medicine/CCT

Salt Lake City, Utah, 84117, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: EmitBio

info@emitbio.com

919-321-1734

Study Officials

• Study Director EB-P30-01

  EmitBio

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Volunteers meeting all inclusion criteria and none of the exclusion criteria will be randomized to the RD-X19 treatment arm or the sham treatment arm within each cohort in a 1:1 ratio according to a fixed schedule via a permuted block design.

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 18, 2023
• Study Start: April 21, 2023
• Primary Completion: June 15, 2024
• Study Completion: June 30, 2024
• Last Updated: October 24, 2024
• Results First Posted: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (48)