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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- EmitBio Inc.
- Enrollment
- 330
- Locations
- 48
- Primary Endpoint
- 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)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •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.
Exclusion Criteria
- •Positive for Influenza A and B antigen using an FDA-authorized rapid diagnostic test.
- •Individuals \< age 40 on study day
- •Individuals who are symptomatic for COVID-19 for more than 72 hours on study day
- •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
- •History of recurrent alcohol intoxication or other recreational drug use (excluding medically prescribed cannabis) within one month of study day
- •History of use, within one month of study day 1, of any FDA-authorized treatment for COVID-
- •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
Outcomes
Primary Outcomes
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)
Time Frame: Baseline through Day 14
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.
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)
Time Frame: Baseline through Day 14
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.
Secondary Outcomes
- 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)