COVID19
Conditions
Brief summary
This is a randomized, sham controlled, dose finding study of the EmitBio RD-X19 device in individuals with symptomatic COVID-19 in the outpatient setting.
Detailed description
This is a randomized, sham controlled, dose finding study of the EmitBio RD-X19 device in individuals with symptomatic COVID-19 in the outpatient setting. Study subjects will self-administer treatment twice daily for 7 days with a one-week follow-up period at Day 14 (+/- 2 days) and will not be aware of which treatment group to which they have been randomized. Clinical outcomes will be assessed via patient reported outcomes (questionnaire and diary cards) and virologic outcomes will be assessed post baseline on Days 3, 5, 8, and 14 via biospecimen collection. The primary goal of the study is to evaluate multiple doses of the RD-X19 treatment device and establish evidence for safety and efficacy for each of the RD-X19 doses compared to sham in SARS-CoV-2 infected individuals with outpatient COVID-19. The primary efficacy outcome is time to sustained symptom resolution. Other clinical and microbiological outcomes will also be assessed. Safety and tolerability (local reactogenicity) will be assessed actively and study subject diary card data recorded at each clinic visit by review of potential treatment emergent adverse events (TEAEs) and targeted oral and physical examinations. Volunteers will be instructed to contact designated clinical trial staff for AEs of a medically-urgent nature as soon as is practically possible and to seek immediate medical care, if needed. Study subjects who experience progression of disease to a grade 3 severity score (e.g SpO2 ≤ 93%, or respiratory rate ≥30/ minute on room air) will be instructed to urgently seek medical care at their nearest Urgent Care or Emergency Department. Study subjects who progress to severe acute respiratory distress syndrome with substantial risk for mortality without immediate medical intervention will be referred directly by site staff to their closest hospital. All study subjects who are hospitalized will be tracked to assess time to hospital discharge or death; the time and date of these events will be captured as part of the trial data. Metabolic, liver, kidney and hematological laboratory evaluations will be performed at baseline and at Day 14 or early termination (and potentially during unscheduled) clinic visits. Methemoglobin assessments will be performed at baseline and Day 14.
Interventions
DEVICERD-X19
Investigational device that uses safe electromagnetic energy to target the oropharynx.
DEVICESham
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..
Sponsors
EmitBio Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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 2:1 ratio according to a fixed schedule via a permuted block design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Positive for SARS-CoV-2 as detected using an FDA authorized SARS-CoV-2 antigen test at or within 24 hours of the screening visit. 2. COVID-19 signs and symptoms within 72 hours from symptom onset, including at least two moderate\* or greater symptoms from: cough, sore throat, nasal congestion, headache, unexplained chills and/or sweats, myalgia, fatigue, nausea (with or without vomiting). o Alternatively, subjects with the presence of at least one moderate symptom and either a) a fever with an oral temperature of at least 100.5° F or b) shortness of breath/difficulty breathing on exertion (e.g., walking, going up and down stairs) are also eligible for enrollment. 3. BMI \<40 4. Provides written informed consent prior to initiation of any study procedures. 5. Be able to understand and agrees to comply with planned study procedures and be available for all study visits. 6. Agrees to the collection of saliva, nasopharyngeal, and venous blood specimens per protocol. 7. Males or females, 18 to 65 years of age, inclusive. 8. No uncontrolled disease process(es) based on patient reported medical history (chronic or acute), other than direct COVID-19 signs and symptoms. 9. 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. * Symptom scoring is independent from the classification of COVID-19 disease severity at baseline. Guidance to study subjects for grading of signs and symptoms will be based on definitions used for the grading of TEAEs: * None (Grade 0): Not present * Mild (Grade 1): Symptoms that are usually transient and may require only minimal or no palliative or specific therapeutic intervention and generally do not interfere with the subject's usual activities of daily living. * Moderate (Grade 2): Symptoms that are usually alleviated with palliative or specific therapeutic intervention. The symptoms interfere with usual activities of daily living causing discomfort but pose no significant or permanent risk of harm to the study subject. * Severe (Grade 3): Events interrupt usual activities of daily living, or significantly effect clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating.
Exclusion criteria
1. Positive urine pregnancy test at screening or females who intend to become pregnant during the study. 2. COVID-19 signs associated with severe respiratory distress or imminent serious medical outcomes.\^\^ \^\^Potential Study Subjects Presenting with any of the following should be referred for immediate medical care and are not eligible for the study * Fever \> 104° F * Cough with sputum production * Rales and/or rhonchi * Difficulty breathing with respiratory distress defined by a respiratory rate ≥30 per minute, heart rate ≥125 per minute, SpO2 ≤93% on room air at sea level or PaO2/FiO2 \<300. * Persistent pain or pressure in the chest * Confusion 3. Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation. 4. Reports a recent positive test result (within the past 6 months) for hepatitis A, hepatitis B or, hepatitis C virus antibody, or HIV-1 antibodies at screening. 5. Has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 1 month of Study Day 1. 6. Currently enrolled in or plans to participate in another clinical trial with a therapeutic investigational agent (e.g., monoclonal antibody, oral protease inhibitor) that will be received during the study period. 7. History of systemic antiviral therapies (e.g., remdesivir) within the past 30 days. 8. History of oral or parenteral corticosteroid use within the past 30 days. Active use of nasal or inhalable steroids is also exclusionary. Topical steroids are not exclusionary. 9. Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to sun exposure. 10. Currently undergoing photodynamic therapy (PDT) or photochemotherapy (PUVA) for an unrelated disease or condition that utilizes photosensitizing drugs including but not limited to 5-aminolevulinic acid, Methyl-5-aminolevulinic acid, porfimer sodium, methoxsalen (8-methoxypsoralen), 5-methoxypsoralen, trioxsalen. 11. Has any oral abnormality (e.g., ulcer, oral candidiasis, oral mucositis, gingivitis) that in the opinion of the investigator would interfere with device use and evaluation. 12. Any intra-oral body piercings that cannot be removed and remain removed for the duration of the study. Metal orthodontia is permitted as braces will be covered by the device mouthpiece. 13. Any individual without teeth or with a dental malformation that precludes directed use of the device as intended.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Sustained Resolution of COVID-19 Signs and Symptoms in All Subjects (With Mild or Moderate Disease at Baseline). | Baseline thru 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 reporting a persistent fever (100.5 degrees for 36 hours or more) and/or SpO2 levels \<96% with any shortness of breath are considered not to have met the success criterion on that day even if all other symptoms are reported as none (0) or mild (1). |
| Sustained Resolution of COVID-19 Signs and Symptoms in Subjects With Mild Disease at Baseline. | Baseline thru 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 reporting a persistent fever (100.5 degrees for 36 hours or more) and/or SpO2 levels \<96% with any shortness of breath are considered not to have met the success criterion on that day even if all other symptoms are reported as none (0) or mild (1). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalizations | Baseline thru Day 14 | Numbers and percentages of study subjects who require hospitalization for severe COVID-19. |
| Worsening of Disease | Day 3 thru Day 14 | Number and percentage of study subjects who experience progression of COVID-19 as defined by an increase of the composite COVID-19 severity score greater than baseline at any point in the study on or after day 3. |
| Return to Pre-COVID Health | Days 8 and 14 | Numbers and percentages of study subjects on day 8 and day 14 who answer yes to the following patient-reported global impression assessments, a) return to usual health and b) return to usual activities. 1. In the past 24 hours, have you returned to your usual health (before your COVID-19 illness)? Yes or No 2. In the past 24 hours, have you returned to your usual activities (before your COVID-19 illness)? Yes or No Note: subjects with missing Data at Day 8 or Day 14 were not included in total subjects analyzed |
| Mean Change in Nasopharyngeal Viral Load | Days 3, 5, 8 and 14 | Mean change in nasopharyngeal viral load from baseline on days 3, 5, 8, and 14. |
| Medically Attended Visits | Baseline thru Day 14 | Numbers and percentages of study subjects who require medical attention or intervention attributed to COVID-19; |
| Day 8 Composite Resolution | Baseline thru Day 8 | Proportion of study subjects who achieve Day 8 Composite Resolution. |
| Endotracheal Ventilation or ECMO | Baseline thru Day 14 | Number and percentage of study subjects who require endotracheal ventilation or ECMO with or without the use of solumedrol. |
| Death | Baseline thru Day 14 | Number and percentage of study subjects who die. |
| Proportion of Subjects Demonstrating Clearance of Viral Infection | Days 3, 5, 8 and 14 | Proportion of subjects demonstrating clearance of viral infection on Days 3, 5, 8 and 14. |
| Severe Disease Progression | Baseline thru Day 14 | Numbers and percentages of study subjects who progress to severe disease with respiratory rate \>30/minute and/or O2 saturation \</=93% on room air or FiO2 ≥300% with any respiratory distress. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RD-X19 Device, Dose A RD-X19. Investigational device that uses safe electromagnetic energy to target the oropharynx.
RD-X19: Investigational device that uses safe electromagnetic energy to target the oropharynx. | 28 |
| RD-X19 Device, Dose B RD-X19. Investigational device that uses safe electromagnetic energy to target the oropharynx.
RD-X19: Investigational device that uses safe electromagnetic energy to target the oropharynx. | 117 |
| 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: 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.. | 71 |
| Total | 216 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | RD-X19 Device, Dose A | Total | Sham Device | RD-X19 Device, Dose B |
|---|---|---|---|---|
| Age, Continuous Age in years | 38.3 years STANDARD_DEVIATION 11.76 | 38.4 years STANDARD_DEVIATION 12.69 | 38.6 years STANDARD_DEVIATION 13.39 | 38.3 years STANDARD_DEVIATION 12.57 |
| Baseline disease Severity Mild COVID | 26 Participants | 135 Participants | 45 Participants | 64 Participants |
| Baseline disease Severity Moderate COVID | 2 Participants | 81 Participants | 26 Participants | 53 Participants |
| COVID-19 Composite Severity Score | 1.496 units on a scale STANDARD_DEVIATION 0.4481 | 1.468 units on a scale STANDARD_DEVIATION 0.4654 | 1.438 units on a scale STANDARD_DEVIATION 0.4914 | 1.480 units on a scale STANDARD_DEVIATION 0.4563 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 67 Participants | 22 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 149 Participants | 49 Participants | 93 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 4 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 23 Participants | 5 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 5 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 27 Participants | 184 Participants | 63 Participants | 94 Participants |
| Region of Enrollment United States | 28 participants | 216 participants | 71 participants | 117 participants |
| Sex: Female, Male Female | 13 Participants | 111 Participants | 35 Participants | 63 Participants |
| Sex: Female, Male Male | 15 Participants | 105 Participants | 36 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 117 | 0 / 71 |
| other Total, other adverse events | 19 / 28 | 55 / 117 | 39 / 71 |
| serious Total, serious adverse events | 4 / 28 | 3 / 117 | 2 / 71 |
Outcome results
Primary
Sustained Resolution of COVID-19 Signs and Symptoms in Subjects With Mild Disease at Baseline.
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 reporting a persistent fever (100.5 degrees for 36 hours or more) and/or SpO2 levels \<96% with any shortness of breath are considered not to have met the success criterion on that day even if all other symptoms are reported as none (0) or mild (1).
Time frame: Baseline thru Day 14
Population: Cohort B, subject of subjects with mild disease at baseline
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| RD-X19 Device, Dose B | Sustained Resolution of COVID-19 Signs and Symptoms in Subjects With Mild Disease at Baseline. | Median Time of Sustained Resolution | 99.3 Time in hours |
| RD-X19 Device, Dose B | Sustained Resolution of COVID-19 Signs and Symptoms in Subjects With Mild Disease at Baseline. | 25th Percentile of Time to Sustained Resolution | 54.8 Time in hours |
| RD-X19 Device, Dose B | Sustained Resolution of COVID-19 Signs and Symptoms in Subjects With Mild Disease at Baseline. | 75th Percentile of Time to Sustained Resolution | 164.8 Time in hours |
| RD-X19 Device, Cohort A | Sustained Resolution of COVID-19 Signs and Symptoms in Subjects With Mild Disease at Baseline. | 75th Percentile of Time to Sustained Resolution | 196.6 Time in hours |
| RD-X19 Device, Cohort A | Sustained Resolution of COVID-19 Signs and Symptoms in Subjects With Mild Disease at Baseline. | Median Time of Sustained Resolution | 119.5 Time in hours |
| RD-X19 Device, Cohort A | Sustained Resolution of COVID-19 Signs and Symptoms in Subjects With Mild Disease at Baseline. | 25th Percentile of Time to Sustained Resolution | 47.9 Time in hours |
| Sham Device | Sustained Resolution of COVID-19 Signs and Symptoms in Subjects With Mild Disease at Baseline. | Median Time of Sustained Resolution | 172.1 Time in hours |
| Sham Device | Sustained Resolution of COVID-19 Signs and Symptoms in Subjects With Mild Disease at Baseline. | 25th Percentile of Time to Sustained Resolution | 87.9 Time in hours |
| Sham Device | Sustained Resolution of COVID-19 Signs and Symptoms in Subjects With Mild Disease at Baseline. | 75th Percentile of Time to Sustained Resolution | 254.7 Time in hours |
p-value: 0.151295% CI: [0.887, 2.172]Regression, Cox
Primary
Time to Sustained Resolution of COVID-19 Signs and Symptoms in All Subjects (With Mild or Moderate Disease at Baseline).
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 reporting a persistent fever (100.5 degrees for 36 hours or more) and/or SpO2 levels \<96% with any shortness of breath are considered not to have met the success criterion on that day even if all other symptoms are reported as none (0) or mild (1).
Time frame: Baseline thru Day 14
Population: Cohort B, subjects with mild or moderate disease at baseline. Primary analysis was not performed on Cohort A
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| RD-X19 Device, Dose B | Time to Sustained Resolution of COVID-19 Signs and Symptoms in All Subjects (With Mild or Moderate Disease at Baseline). | 25th Percentile of Time to Sustained Resolution | 63.8 Time in hours |
| RD-X19 Device, Dose B | Time to Sustained Resolution of COVID-19 Signs and Symptoms in All Subjects (With Mild or Moderate Disease at Baseline). | Median of Time to Sustained Resolution | 113.5 Time in hours |
| RD-X19 Device, Dose B | Time to Sustained Resolution of COVID-19 Signs and Symptoms in All Subjects (With Mild or Moderate Disease at Baseline). | 75th Percentile of Time to Sustained Resolution | 190.6 Time in hours |
| RD-X19 Device, Cohort A | Time to Sustained Resolution of COVID-19 Signs and Symptoms in All Subjects (With Mild or Moderate Disease at Baseline). | 25th Percentile of Time to Sustained Resolution | 91.6 Time in hours |
| RD-X19 Device, Cohort A | Time to Sustained Resolution of COVID-19 Signs and Symptoms in All Subjects (With Mild or Moderate Disease at Baseline). | 75th Percentile of Time to Sustained Resolution | 266.3 Time in hours |
| RD-X19 Device, Cohort A | Time to Sustained Resolution of COVID-19 Signs and Symptoms in All Subjects (With Mild or Moderate Disease at Baseline). | Median of Time to Sustained Resolution | 172.1 Time in hours |
| Sham Device | Time to Sustained Resolution of COVID-19 Signs and Symptoms in All Subjects (With Mild or Moderate Disease at Baseline). | Median of Time to Sustained Resolution | 115.1 Time in hours |
| Sham Device | Time to Sustained Resolution of COVID-19 Signs and Symptoms in All Subjects (With Mild or Moderate Disease at Baseline). | 75th Percentile of Time to Sustained Resolution | 196.6 Time in hours |
| Sham Device | Time to Sustained Resolution of COVID-19 Signs and Symptoms in All Subjects (With Mild or Moderate Disease at Baseline). | 25th Percentile of Time to Sustained Resolution | 55.4 Time in hours |
Comparison: Log Rank Test and Cox PH Regression analyses were performed unstratifiedp-value: 0.978495% CI: [0.717, 1.408]Regression, Cox
Secondary
Day 8 Composite Resolution
Proportion of study subjects who achieve Day 8 Composite Resolution.
Time frame: Baseline thru Day 8
Population: N (%) subjects achieving success on Composite Resolution
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RD-X19 Device, Dose B | Day 8 Composite Resolution | 14 Participants |
| RD-X19 Device, Cohort A | Day 8 Composite Resolution | 81 Participants |
| Sham Device | Day 8 Composite Resolution | 48 Participants |
Secondary
Death
Number and percentage of study subjects who die.
Time frame: Baseline thru Day 14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RD-X19 Device, Dose B | Death | 0 Participants |
| RD-X19 Device, Cohort A | Death | 0 Participants |
| Sham Device | Death | 0 Participants |
Secondary
Endotracheal Ventilation or ECMO
Number and percentage of study subjects who require endotracheal ventilation or ECMO with or without the use of solumedrol.
Time frame: Baseline thru Day 14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RD-X19 Device, Dose B | Endotracheal Ventilation or ECMO | 0 Participants |
| RD-X19 Device, Cohort A | Endotracheal Ventilation or ECMO | 0 Participants |
| Sham Device | Endotracheal Ventilation or ECMO | 0 Participants |
Secondary
Hospitalizations
Numbers and percentages of study subjects who require hospitalization for severe COVID-19.
Time frame: Baseline thru Day 14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RD-X19 Device, Dose B | Hospitalizations | 4 Participants |
| RD-X19 Device, Cohort A | Hospitalizations | 3 Participants |
| Sham Device | Hospitalizations | 2 Participants |
Secondary
Mean Change in Nasopharyngeal Viral Load
Mean change in nasopharyngeal viral load from baseline on days 3, 5, 8, and 14.
Time frame: Days 3, 5, 8 and 14
Population: Subjects with Mild and Moderate Disease at Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RD-X19 Device, Dose B | Mean Change in Nasopharyngeal Viral Load | Day 8 | -3.663 Log10 copies/mL | Standard Deviation 1.8057 |
| RD-X19 Device, Dose B | Mean Change in Nasopharyngeal Viral Load | Day 14 | -4.827 Log10 copies/mL | Standard Deviation 1.6769 |
| RD-X19 Device, Dose B | Mean Change in Nasopharyngeal Viral Load | Day 3 | -0.849 Log10 copies/mL | Standard Deviation 0.8828 |
| RD-X19 Device, Dose B | Mean Change in Nasopharyngeal Viral Load | Day 5 | -2.218 Log10 copies/mL | Standard Deviation 0.9273 |
| RD-X19 Device, Cohort A | Mean Change in Nasopharyngeal Viral Load | Day 3 | -1.269 Log10 copies/mL | Standard Deviation 1.0666 |
| RD-X19 Device, Cohort A | Mean Change in Nasopharyngeal Viral Load | Day 5 | -2.649 Log10 copies/mL | Standard Deviation 1.6975 |
| RD-X19 Device, Cohort A | Mean Change in Nasopharyngeal Viral Load | Day 14 | -5.584 Log10 copies/mL | Standard Deviation 1.5876 |
| RD-X19 Device, Cohort A | Mean Change in Nasopharyngeal Viral Load | Day 8 | -4.132 Log10 copies/mL | Standard Deviation 1.9791 |
| Sham Device | Mean Change in Nasopharyngeal Viral Load | Day 14 | -5.084 Log10 copies/mL | Standard Deviation 2.1024 |
| Sham Device | Mean Change in Nasopharyngeal Viral Load | Day 3 | -0.928 Log10 copies/mL | Standard Deviation 1.7048 |
| Sham Device | Mean Change in Nasopharyngeal Viral Load | Day 5 | -2.107 Log10 copies/mL | Standard Deviation 1.9003 |
| Sham Device | Mean Change in Nasopharyngeal Viral Load | Day 8 | -3.744 Log10 copies/mL | Standard Deviation 1.8545 |
Secondary
Medically Attended Visits
Numbers and percentages of study subjects who require medical attention or intervention attributed to COVID-19;
Time frame: Baseline thru Day 14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RD-X19 Device, Dose B | Medically Attended Visits | 5 Participants |
| RD-X19 Device, Cohort A | Medically Attended Visits | 5 Participants |
| Sham Device | Medically Attended Visits | 2 Participants |
Secondary
Proportion of Subjects Demonstrating Clearance of Viral Infection
Proportion of subjects demonstrating clearance of viral infection on Days 3, 5, 8 and 14.
Time frame: Days 3, 5, 8 and 14
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RD-X19 Device, Dose B | Proportion of Subjects Demonstrating Clearance of Viral Infection | Day 3 | 0 Participants |
| RD-X19 Device, Dose B | Proportion of Subjects Demonstrating Clearance of Viral Infection | Day 5 | 0 Participants |
| RD-X19 Device, Dose B | Proportion of Subjects Demonstrating Clearance of Viral Infection | Day 8 | 1 Participants |
| RD-X19 Device, Dose B | Proportion of Subjects Demonstrating Clearance of Viral Infection | Day 14 | 2 Participants |
| RD-X19 Device, Cohort A | Proportion of Subjects Demonstrating Clearance of Viral Infection | Day 14 | 68 Participants |
| RD-X19 Device, Cohort A | Proportion of Subjects Demonstrating Clearance of Viral Infection | Day 3 | 2 Participants |
| RD-X19 Device, Cohort A | Proportion of Subjects Demonstrating Clearance of Viral Infection | Day 8 | 34 Participants |
| RD-X19 Device, Cohort A | Proportion of Subjects Demonstrating Clearance of Viral Infection | Day 5 | 15 Participants |
| Sham Device | Proportion of Subjects Demonstrating Clearance of Viral Infection | Day 14 | 34 Participants |
| Sham Device | Proportion of Subjects Demonstrating Clearance of Viral Infection | Day 5 | 6 Participants |
| Sham Device | Proportion of Subjects Demonstrating Clearance of Viral Infection | Day 8 | 19 Participants |
| Sham Device | Proportion of Subjects Demonstrating Clearance of Viral Infection | Day 3 | 4 Participants |
Secondary
Return to Pre-COVID Health
Numbers and percentages of study subjects on day 8 and day 14 who answer yes to the following patient-reported global impression assessments, a) return to usual health and b) return to usual activities. 1. In the past 24 hours, have you returned to your usual health (before your COVID-19 illness)? Yes or No 2. In the past 24 hours, have you returned to your usual activities (before your COVID-19 illness)? Yes or No Note: subjects with missing Data at Day 8 or Day 14 were not included in total subjects analyzed
Time frame: Days 8 and 14
Population: Visit 4/Day8
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RD-X19 Device, Dose B | Return to Pre-COVID Health | Subjects who returned to usual health on Day 8 | 10 Participants |
| RD-X19 Device, Dose B | Return to Pre-COVID Health | Subjects who returned to usual health on Day 14 | 17 Participants |
| RD-X19 Device, Dose B | Return to Pre-COVID Health | Subjects who returned to usual activities on Day 8 | 9 Participants |
| RD-X19 Device, Dose B | Return to Pre-COVID Health | Subjects who returned to usual activities on Day 14 | 16 Participants |
| RD-X19 Device, Cohort A | Return to Pre-COVID Health | Subjects who returned to usual activities on Day 8 | 74 Participants |
| RD-X19 Device, Cohort A | Return to Pre-COVID Health | Subjects who returned to usual health on Day 14 | 84 Participants |
| RD-X19 Device, Cohort A | Return to Pre-COVID Health | Subjects who returned to usual health on Day 8 | 54 Participants |
| RD-X19 Device, Cohort A | Return to Pre-COVID Health | Subjects who returned to usual activities on Day 14 | 96 Participants |
| Sham Device | Return to Pre-COVID Health | Subjects who returned to usual activities on Day 8 | 41 Participants |
| Sham Device | Return to Pre-COVID Health | Subjects who returned to usual health on Day 14 | 49 Participants |
| Sham Device | Return to Pre-COVID Health | Subjects who returned to usual activities on Day 14 | 56 Participants |
| Sham Device | Return to Pre-COVID Health | Subjects who returned to usual health on Day 8 | 27 Participants |
Secondary
Severe Disease Progression
Numbers and percentages of study subjects who progress to severe disease with respiratory rate \>30/minute and/or O2 saturation \</=93% on room air or FiO2 ≥300% with any respiratory distress.
Time frame: Baseline thru Day 14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RD-X19 Device, Dose B | Severe Disease Progression | 3 Participants |
| RD-X19 Device, Cohort A | Severe Disease Progression | 2 Participants |
| Sham Device | Severe Disease Progression | 1 Participants |
Secondary
Worsening of Disease
Number and percentage of study subjects who experience progression of COVID-19 as defined by an increase of the composite COVID-19 severity score greater than baseline at any point in the study on or after day 3.
Time frame: Day 3 thru Day 14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RD-X19 Device, Dose B | Worsening of Disease | 5 Participants |
| RD-X19 Device, Cohort A | Worsening of Disease | 10 Participants |
| Sham Device | Worsening of Disease | 11 Participants |