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

Launched by EMITBIO INC. · Apr 14, 2023

Keywords

ClinConnect Summary

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 v...

Gender

ALL

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.