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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RD-X19 Device, Dose A | Active Comparator | RD-X19. Investigational device that delivers 24 J/cm2 of electromagnetic energy to the oropharynx. |
|
| RD-X19 Device, Dose B | Active Comparator | RD-X19. Investigational device that delivers 32 J/cm2 of electromagnetic energy to the oropharynx. |
|
| Sham Device | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RD-X19 | Device | Investigational device that uses safe electromagnetic energy to target the oropharynx. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline thru Day 14 |
| 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). | Baseline thru Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Medically Attended Visits | Numbers and percentages of study subjects who require medical attention or intervention attributed to COVID-19; | Baseline thru Day 14 |
| Severe Disease Progression | Numbers and percentages of study subjects who progress to severe disease with respiratory rate >30/minute and/or O2 saturation \ |
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Inclusion Criteria
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.
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.
BMI <40
Provides written informed consent prior to initiation of any study procedures.
Be able to understand and agrees to comply with planned study procedures and be available for all study visits.
Agrees to the collection of saliva, nasopharyngeal, and venous blood specimens per protocol.
Males or females, 18 to 65 years of age, inclusive.
No uncontrolled disease process(es) based on patient reported medical history (chronic or acute), other than direct COVID-19 signs and symptoms.
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:
Exclusion Criteria
Positive urine pregnancy test at screening or females who intend to become pregnant during the study.
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
Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
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.
Has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 1 month of Study Day 1.
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.
History of systemic antiviral therapies (e.g., remdesivir) within the past 30 days.
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.
Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to sun exposure.
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.
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.
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.
Any individual without teeth or with a dental malformation that precludes directed use of the device as intended.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | EmitBio | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 2 - Innovative Research of West Florida, Inc. | Clearwater | Florida | 33756 | United States | ||
| Site 1 - APF Research LLC |
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| ID | Title | Description |
|---|---|---|
| FG000 | RD-X19 Device, Dose A | Investigational device that delivers 24 J/cm2 |
| FG001 | RD-X19 Device, Dose B | Investigational device that delivers 32 J/cm2 |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | RD-X19 Device, Dose B |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Cohort B, subjects with mild or moderate disease at baseline. Primary analysis was not performed on Cohort A | Posted | Median | 95% Confidence Interval | Time in hours | Baseline thru Day 14 |
|
Through day 14 (±2 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Administrative Site Pain | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | EmitBio Inc | 919.321.1734 | info@emitbio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 17, 2022 | Jan 10, 2024 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 2, 2022 | Oct 16, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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.
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| 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.. |
|
| Baseline thru Day 14 |
| Hospitalizations | Numbers and percentages of study subjects who require hospitalization for severe COVID-19. | Baseline thru Day 14 |
| 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. | Day 3 thru Day 14 |
| 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.
Note: subjects with missing Data at Day 8 or Day 14 were not included in total subjects analyzed | Days 8 and 14 |
| Mean Change in Nasopharyngeal Viral Load | Mean change in nasopharyngeal viral load from baseline on days 3, 5, 8, and 14. | Days 3, 5, 8 and 14 |
| Proportion of Subjects Demonstrating Clearance of Viral Infection | Proportion of subjects demonstrating clearance of viral infection on Days 3, 5, 8 and 14. | Days 3, 5, 8 and 14 |
| Day 8 Composite Resolution | Proportion of study subjects who achieve Day 8 Composite Resolution. | Baseline thru Day 8 |
| Endotracheal Ventilation or ECMO | Number and percentage of study subjects who require endotracheal ventilation or ECMO with or without the use of solumedrol. | Baseline thru Day 14 |
| Death | Number and percentage of study subjects who die. | Baseline thru Day 14 |
| Miami |
| Florida |
| 33134 |
| United States |
| Site 8 - WellNow Urgent Care | Kalamazoo | Michigan | 49048 | United States |
| Site 9 - Revival Research Institute, LLC | Sterling Heights | Michigan | 48312 | United States |
| Site 4 - Peters Medical Research | High Point | North Carolina | 27260 | United States |
| Site 7 - WellNow Urgent Care | Cincinnati | Ohio | 45215 | United States |
| Site 5 - WellNow Urgent Care | Columbus | Ohio | 43214 | United States |
| Site 6 - WellNow Urgent Care | Dayton | Ohio | 45424 | United States |
| Site 3 - J&S Studies, Inc. | College Station | Texas | 77845 | United States |
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. |
| BG002 | 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.. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| COVID-19 Composite Severity Score | 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). The COVID-19 Composite Severity Score is defined as the sum of the eight individual COVID-19 signs and symptoms severity scores divided by eight. Subjects with scores missing for one or more symptoms will have CSS calculated as the sum of all scores reported divided by the number of scores reported | Mean | Standard Deviation | units on a scale |
|
| Baseline disease Severity | Mild COVID-19 • Positive SARS-CoV-2 diagnostic test, viral symptoms, No shortness of breath, dyspnea, abnormal chest imaging, or any other clinical signs indicative of Moderate or Severe COVID-19 Moderate COVID-19 • Above with clinical signs suggestive of lower airway involvement, such as resting respiratory rate ≥20 breaths per minute or imaging indicating lower airway disease heart rate ≥ 100 beats per minute, with or an oxygen saturation (SpO2) < 96% but ≥94% on room air at sea level. | Count of Participants | Participants |
|
| RD-X19 Device, Dose B |
Investigational device that delivers 32 J/cm2 |
| OG001 | RD-X19 Device, Cohort A | Investigational Device that delivers 16 J/cm2 |
| OG002 | 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. |
|
|
|
| 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). | Cohort B, subject of subjects with mild disease at baseline | Posted | Median | 95% Confidence Interval | Time in hours | Baseline thru Day 14 |
|
|
|
|
| Secondary | Medically Attended Visits | Numbers and percentages of study subjects who require medical attention or intervention attributed to COVID-19; | Posted | Count of Participants | Participants | Baseline thru Day 14 |
|
|
|
| Secondary | Severe Disease Progression | Numbers and percentages of study subjects who progress to severe disease with respiratory rate >30/minute and/or O2 saturation \ | Posted | Count of Participants | Participants | Baseline thru Day 14 |
|
|
|
| Secondary | Hospitalizations | Numbers and percentages of study subjects who require hospitalization for severe COVID-19. | Posted | Count of Participants | Participants | Baseline thru Day 14 |
|
|
|
| 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. | Posted | Count of Participants | Participants | Day 3 thru Day 14 |
|
|
|
| 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.
Note: subjects with missing Data at Day 8 or Day 14 were not included in total subjects analyzed | Visit 4/Day8 | Posted | Count of Participants | Participants | Days 8 and 14 |
|
|
|
| Secondary | Mean Change in Nasopharyngeal Viral Load | Mean change in nasopharyngeal viral load from baseline on days 3, 5, 8, and 14. | Subjects with Mild and Moderate Disease at Baseline | Posted | Mean | Standard Deviation | Log10 copies/mL | Days 3, 5, 8 and 14 |
|
|
|
| Secondary | Proportion of Subjects Demonstrating Clearance of Viral Infection | Proportion of subjects demonstrating clearance of viral infection on Days 3, 5, 8 and 14. | Posted | Count of Participants | Participants | Days 3, 5, 8 and 14 |
|
|
|
| Secondary | Day 8 Composite Resolution | Proportion of study subjects who achieve Day 8 Composite Resolution. | N (%) subjects achieving success on Composite Resolution | Posted | Count of Participants | Participants | Baseline thru Day 8 |
|
|
|
| Secondary | Endotracheal Ventilation or ECMO | Number and percentage of study subjects who require endotracheal ventilation or ECMO with or without the use of solumedrol. | Posted | Count of Participants | Participants | Baseline thru Day 14 |
|
|
|
| Secondary | Death | Number and percentage of study subjects who die. | Posted | Count of Participants | Participants | Baseline thru Day 14 |
|
|
|
| 0 |
| 28 |
| 4 |
| 28 |
| 19 |
| 28 |
| EG001 | 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. | 0 | 117 | 3 | 117 | 55 | 117 |
| EG002 | 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.. | 0 | 71 | 2 | 71 | 39 | 71 |
| Covid-19 Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Covid-19 Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Neutrophil/Lymphocyte Ratio Increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Red Cell Distribution Width Increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Jaw Clicking | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Muscle Spasm | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pain in Jaw | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
All study data and reports of study data are the property of the study sponsor. The sponsor may grant the PI the right to publish the results of this research in a scientific journal, conditional upon the review and concurrence of the sponsor
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| 25th Percentile of Time to Sustained Resolution |
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| 75th Percentile of Time to Sustained Resolution |
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| Subjects who returned to usual activities on Day 8 |
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| Subjects who returned to usual health on Day 14 |
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| Subjects who returned to usual activities on Day 14 |
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| Day 8 |
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| Day 14 |
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| Title | Measurements |
|---|---|
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| Day 8 |
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| Day 14 |
|