Clinical trial NCT05817045: Evaluation of the RD-X19 Treatment Device in Individuals With Mild COVID-19
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: KNOWBio Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-18
Enrollment: 330
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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)
timeFrame: Baseline through Day 14
measure: 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)
timeFrame: Baseline through Day 14
Secondary outcomes:
measure: 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
timeFrame: Baseline through Day 14
measure: Kaplan-Meier Estimates Time to First of Two Negative SARS-CoV-2 Antigen Tests
timeFrame: Baseline through Day 14
Other outcomes:
measure: Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)
timeFrame: Baseline, Day 5, Day 8, and Day 14 or Early Termination Visit
Locations:
city: Mesa
country: United States
facility: 322 - Desert Clinical Research/CCT Research
state: Arizona
city: Phoenix
country: United States
facility: 347 - Velocity Clinical Research
state: Arizona
city: Anaheim
country: United States
facility: 312 - Smart Cures Clinical Research
state: California
city: Colton
country: United States
facility: 313 - Benchmark Southern California
state: California
city: Long Beach
country: United States
facility: 307 - Ark Clinical Research
state: California
city: Northridge
country: United States
facility: 329 - Valley Clinical Trials
state: California
city: San Francisco
country: United States
facility: 348 - San Francisco Research Institute
state: California
city: West Hollywood
country: United States
facility: 328 - Mills Clinical Research
state: California
city: Hialeah
country: United States
facility: 305 - Indago Research and Health Center
state: Florida
city: Kissimmee
country: United States
facility: 321 - Helios Clinical Research - Kissimmee
state: Florida
city: Largo
country: United States
facility: 310 - Accel Research Sites - St. Petersburg
state: Florida
city: Miami
country: United States
facility: 306 - Miami Clinical Research
state: Florida
city: Lilburn
country: United States
facility: 341 - Lifeline Primary Care / CCT Research
state: Georgia
city: Chicago
country: United States
facility: 349 - Chicago Medical Research
state: Illinois
city: Chicago
country: United States
facility: 333 - Prime Global Research Inc.
state: Illinois
city: Chicago
country: United States
facility: 331 - Chicago Clinical Research Institute
state: Illinois
city: West Des Moines
country: United States
facility: 345 - The Iowa Clinic/Avacare Legacy
state: Iowa
city: Versailles
country: United States
facility: 337 - Versailles Family Medicine/CCT Research
state: Kentucky
city: Metairie
country: United States
facility: 346 - Benchmark Research
state: Louisiana
city: Annapolis
country: United States
facility: 323 - Annapolis Internal Medicine/CCT Research
state: Maryland
city: Rockville
country: United States
facility: 324 - Advanced Primary and Geriatric Care / CCT Research
state: Maryland
city: Springfield
country: United States
facility: 327 - The Research Institute
state: Massachusetts
city: Dearborn
country: United States
facility: 315 - Revival Research Institute - Dearborn
state: Michigan
city: Sterling Heights
country: United States
facility: 314 - Revival Research Institute - Sterling Heights
state: Michigan
city: Olive Branch
country: United States
facility: 318 - Olive Branch Family Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: 335 - Clay Platte Family Medicine/CCT Research
state: Missouri
city: Saint Louis
country: United States
facility: 336 - St. Louis Medical Professional/CCT Research
state: Missouri
city: Elkhorn
country: United States
facility: 344 - Skyline Medical Center/ CCT Research
state: Nebraska
city: Las Vegas
country: United States
facility: 326 - Healor Primary Care
state: Nevada
city: Las Vegas
country: United States
facility: 325 - Santa Rosa Medical Centers of Nevada / CCT Research
state: Nevada
city: Bronx
country: United States
facility: 332 - Prime Global Research Inc.
state: New York
city: E. Amherst
country: United States
facility: 302 - WellNow - East Amherst
state: New York
city: Niskayuna
country: United States
facility: 316 - WellNow - Niskayuna
state: New York
city: Asheville
country: United States
facility: 338 - Carolina Internal Medicine Associates
state: North Carolina
city: Raleigh
country: United States
facility: 320 - M3 Wake Research
state: North Carolina
city: Cincinnati
country: United States
facility: 304 - WellNow - Cincinnati
state: Ohio
city: Columbus
country: United States
facility: 301 - WellNow - Columbus
state: Ohio
city: Dayton
country: United States
facility: 303 - WellNow - Huber Heights
state: Ohio
city: Elizabethton
country: United States
facility: 334 - Medical Care/CCT Research
state: Tennessee
city: Hendersonville
country: United States
facility: 308B - Kurr Research @ Complete Health Partners
state: Tennessee
city: Nashville
country: United States
facility: 308 - Kur Research @Complete Health Partners
state: Tennessee
city: Houston
country: United States
facility: 330 - Clinical Trial Network
state: Texas
city: Keller
country: United States
facility: 319 - Helios Clinical Research - Keller
state: Texas
city: Webster
country: United States
facility: 309 - Tranquility Clinical Research
state: Texas
city: American Fork
country: United States
facility: 340 - Premier Family Medical/CCT Research
state: Utah
city: Bountiful
country: United States
facility: 343 - Cope Family Medicine/ CCT Research
state: Utah
city: Roy
country: United States
facility: 342 - Ogden Clinical, Grand View/CCT Research
state: Utah
city: Salt Lake City
country: United States
facility: 339 - Olympus Family Medicine/CCT
state: Utah
Study officials:
affiliation: EmitBio
name: Study Director EB-P30-01
role: STUDY_DIRECTOR
References: