COVID19NCT04966013
Evaluation of the RD-X19 Treatment Device in Individuals With Mild to Moderate COVID-19
A study testing RD-X19 in people with COVID19, run by EmitBio Inc. at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID19
- What is being tested?
- RD-X19
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 9 sitesUnited States
- Study dates
- 17 Jun 2021to 23 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- 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.
Who cannot join
- 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
- Fever > 104° F
- Cough with sputum production
- Rales and/or rhonchi
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- 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
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Site 7 - WellNow Urgent Care
Cincinnati, Ohio, 45215
Site 2 - Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756
Site 3 - J&S Studies, Inc.
College Station, Texas, 77845
Site 5 - WellNow Urgent Care
Columbus, Ohio, 43214
Site 6 - WellNow Urgent Care
Dayton, Ohio, 45424
Site 4 - Peters Medical Research
High Point, North Carolina, 27260
Site 8 - WellNow Urgent Care
Kalamazoo, Michigan, 49048
Site 1 - APF Research LLC
Miami, Florida, 33134
Site 9 - Revival Research Institute, LLC
Sterling Heights, Michigan, 48312
About this study
Official title: A Phase II, Randomized, Sham Controlled Dose Finding Study of the RD-X19 Treatment Device in Individuals With Mild to Moderate COVID-19
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.
Read the 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.
- Conditions
- COVID19
- Being tested
- RD-X19, Sham
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RD-X19Device
Investigational device that uses safe electromagnetic energy to target the oropharynx.
ShamDevice
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..
| Study group | Role | What they receive |
|---|---|---|
| RD-X19 Device, Dose A | Active comparator | RD-X19. Investigational device that delivers 24 J/cm2 of electromagnetic energy to the oropharynx. Receives: Device: RD-X19 |
| RD-X19 Device, Dose B | Active comparator | RD-X19. Investigational device that delivers 32 J/cm2 of electromagnetic energy to the oropharynx. Receives: Device: RD-X19 |
| 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. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline thru Day 14
Secondary outcomes (10)
Medically Attended Visits
Numbers and percentages of study subjects who require medical attention or intervention attributed to COVID-19;
Measured: 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 </=93% on room air or FiO2 ≥300% with any respiratory distress.
Measured: Baseline thru Day 14
Hospitalizations
Numbers and percentages of study subjects who require hospitalization for severe COVID-19.
Measured: 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.
Measured: 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.
- In the past 24 hours, have you returned to your usual health (before your COVID-19 illness)? Yes or No
- 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
Measured: 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.
Measured: 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.
Measured: Days 3, 5, 8 and 14
Day 8 Composite Resolution
Proportion of study subjects who achieve Day 8 Composite Resolution.
Measured: 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.
Measured: Baseline thru Day 14
Death
Number and percentage of study subjects who die.
Measured: Baseline thru Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start17 Jun 2021
- Primary completion5 Jan 2022
- Study completion23 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- EmitBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, EmitBio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966013
- Sponsor's protocol ID
- EB-P20-01
- Status last verified
- Aug 2024
- First submitted
- 9 Jul 2021
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Sham Controlled Dose Finding Study of the RD-X19 Treatment Device in Individuals With Mild to Moderate COVID-19
- ClinicalTrials.gov ID
- NCT04966013
- Acronym / sponsor ID
- EB-P20-01
- Conditions
- COVID19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- EmitBio Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 23 Feb 2022 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| RD-X19 Device, Dose A | Active comparator | Device: RD-X19RD-X19. Investigational device that delivers 24 J/cm2 of electromagnetic energy to the oropharynx. |
| RD-X19 Device, Dose B | Active comparator | Device: RD-X19RD-X19. Investigational device that delivers 32 J/cm2 of electromagnetic energy to the oropharynx. |
| Sham Device | Sham comparator | Device: ShamInvestigational 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RD-X19Investigational device that uses safe electromagnetic energy to target the oropharynx. | Device | RD-X19 Device, Dose A, RD-X19 Device, Dose B |
| ShamInvestigational 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.. | Device | Sham Device |
Primary outcome
Time to Sustained Resolution of COVID-19 Signs and Symptoms in All Subjects (With Mild or Moderate Disease at Baseline).
Time frame: 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.
Time frame: 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).
10 secondary outcomes
Medically Attended Visits
Time frame: Baseline thru Day 14
Severe Disease Progression
Time frame: Baseline thru Day 14
Hospitalizations
Time frame: Baseline thru Day 14
Worsening of Disease
Time frame: Day 3 thru Day 14
Return to Pre-COVID Health
Time frame: Days 8 and 14
Mean Change in Nasopharyngeal Viral Load
Time frame: Days 3, 5, 8 and 14
Proportion of Subjects Demonstrating Clearance of Viral Infection
Time frame: Days 3, 5, 8 and 14
Day 8 Composite Resolution
Time frame: Baseline thru Day 8
Endotracheal Ventilation or ECMO
Time frame: Baseline thru Day 14
Death
Time frame: Baseline thru Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
EmitBio
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RD-X19 in people with COVID19, run by EmitBio Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Sustained Resolution of COVID-19 Signs and Symptoms in All Subjects (With Mild or Moderate Disease at Baseline). (time frame: Baseline thru Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.