COVID19NCT04662671
Phase I/II Safety, Dose Finding & Antiviral Activity of RD-X19 in Mild/Moderate Outpatient COVID-19
A study testing RD-X19 in people with COVID19, run by EmitBio Inc. at 2 sites in United States.
Trial summary
This randomized, Phase I/II feasibility study will evaluate the safety and efficacy of the RD-X19 device in SARS-CoV-2 infected individuals with uncomplicated COVID-19. 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
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Nov 2020to 30 Jan 2021
- 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 antigen via nasal swab at or within the past 24 hours of the screening visit detected using an FDA authorized SARS-CoV-2 antigen test.
- Onset of signs and symptoms consistent with COVID-19* no longer than within the past 3 days* and have either a) a fever of at least 100 °F or b) at least two moderate or severe symptoms (cough, sore throat, nasal congestion, headache, chills/sweats, muscle or joint pain, fatigue, and nausea) at the time of screening.
- 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 nasopharyngeal swabs, oropharyngeal swabs, oral saliva specimen collection and venous blood specimens per protocol.
- Agrees to refrain from using oral antiseptics (e.g. hydrogen peroxide rinse, Listerine) or mouthwashes of any kind during the study.
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- Male or non-pregnant female, 18 to 65 years of age, inclusive, at time of enrollment.
- No uncontrolled disease process (chronic or acute), other than 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.
Who cannot join
- Positive urine pregnancy test at screening.
- Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
- Presence of self-reported or medically documented uncontrolled significant medical or psychiatric condition(s) other than COVID-19.
- Reports a recent positive test result (within the past 6 months) for hepatitis B surface antigen, 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.
- COVID-19 signs associated with acute respiratory distress or imminent serious medical outcomes. ^^
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- BMI ≥36
- Subjects living (e.g., siblings, spouses, relatives, roommates) in the same household cannot be enrolled.
- Has participated in another investigational study involving any intervention for SARS-CoV-2/COVID- 19 within the past 6 months or any clinical trial with interventional investigational product within 30 days of screening.
- Currently enrolled in or plans to participate in another clinical trial with an interventional investigational agent that will be received during the studyperiod.
- History of hospitalization within the past 60 days.
- History of systemic antiviral therapies within the past 30 days.
- History of oral corticoid steroid use within the past 14 days or steroid injection within the past 6 months. 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 nitrites, nitrates, or sun exposure.
- Has any oral abnormality (e.g. ulcer, oral mucositis, gingivitis) that in the opinion of the investigator would interfere with device use, or intra-oral metal body piercings that cannot be removed for the duration of the study. Metal orthodontia is permitted as braces will be covered by the device mouthpiece.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Site 1
College Station, Texas, 77845
Site 2
Miami, Florida, 33134
About this study
Official title: Phase I/II Randomized, Dose Escalation Study to Evaluate the Safety and Antiviral Activity of the RD-X19 Device in SARS-CoV-2 Infected Individuals With Uncomplicated COVID-19
This randomized, Phase I/II feasibility study will evaluate the safety and efficacy of the RD-X19 device in SARS-CoV-2 infected individuals with uncomplicated COVID-19.
Read the detailed description
This is a randomized, sham-controlled dose escalation and bioeffect study. The primary goal of the study is to evaluate the safety of the RD-X19 device in SARS-CoV-2 infected individuals with outpatient COVID-19 and to assess the reduction of SARS-CoV-2 viral load in each dose group compared to sham controls.
The primary safety measure is absence of device-related serious adverse events or patterns of severity ≥2 device-related adverse events. Safety and tolerability (local reactogenicity) will be assessed actively on each clinic visit by review of potential adverse events (AEs) and targeted physical examination, as required. Metabolic, liver, kidney and hematological laboratory evaluations will be performed at baseline and at Day 8 or early termination (and potentially during unscheduled) clinic visits.
Methemoglobin assessments will be performed at baseline and Day 8.
Various efficacy assessments will explore the impact of RD-X19 treatment on the reduction in log10 SARS-CoV-2 viral load and alleviation of symptoms associated with COVID-19. Both the magnitude of reduction as a function of dose as well as time to clearance will be assessed.
- Conditions
- COVID19
- Being tested
- RD-X19
- 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
Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens.
| Study group | Role | What they receive |
|---|---|---|
| RD-X19 Device | Experimental | Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens. 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: RD-X19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Measure
Number of Participants with device-related serious adverse events or any patterns of severity ≥2 device-related adverse events in the same SOC grouping of Preferred Terms based on Medical Dictionary for Regulatory Activities (MedDRA) coding, as determined throughout the course of the study.
Measured: Baseline thru Day 8
Primary Efficacy Measure
Time weighted average change in viral load from baseline by RT-qPCR from Day 1 to Day 8.
Measured: Baseline to Day 8
Secondary outcomes (2)
Proportion of Subjects Demonstrating Clearance of Viral Infection
Proportion of subjects demonstrating clearance of viral infection, defined as a negative test via RT-qPCR on Day 8/ET.
Measured: Days 1, 3, 5 and 8
Median Time to Alleviation of Symptoms
Median time to alleviation of symptoms as measured by the time when all eight symptoms (cough, sore throat, nasal congestion, headache, chills/sweats, muscle or joint pain, fatigue, and nausea) had been assessed by the subject as none (0) or mild (1).
Measured: Daily through day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start18 Nov 2020
- Primary completion9 Dec 2020
- Study completion30 Jan 2021
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
- The study will be conducted as a randomized, double-blind, sham-controlled study in SARS-CoV-2 infected individuals with outpatient COVID-19. Subjects will be randomized 2:1 RD-X19 to Sham Device treatment arms.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- EmitBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- EB-P12-01 Study Director, Study director, EmitBio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662671
- Sponsor's protocol ID
- EB-P12-01
- Status last verified
- Aug 2022
- First submitted
- 9 Dec 2020
- Last updated
- 8 Sep 2022
- 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 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Randomized, Dose Escalation Study to Evaluate the Safety and Antiviral Activity of the RD-X19 Device in SARS-CoV-2 Infected Individuals With Uncomplicated COVID-19
- ClinicalTrials.gov ID
- NCT04662671
- Acronym / sponsor ID
- EB-P12-01
- Conditions
- COVID19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- EmitBio Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Posted 8 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, Phase I/II feasibility study will evaluate the safety and efficacy of the RD-X19 device in SARS-CoV-2 infected individuals with uncomplicated COVID-19.
Detailed description
This is a randomized, sham-controlled dose escalation and bioeffect study. The primary goal of the study is to evaluate the safety of the RD-X19 device in SARS-CoV-2 infected individuals with outpatient COVID-19 and to assess the reduction of SARS-CoV-2 viral load in each dose group compared to sham controls.
The primary safety measure is absence of device-related serious adverse events or patterns of severity ≥2 device-related adverse events. Safety and tolerability (local reactogenicity) will be assessed actively on each clinic visit by review of potential adverse events (AEs) and targeted physical examination, as required. Metabolic, liver, kidney and hematological laboratory evaluations will be performed at baseline and at Day 8 or early termination (and potentially during unscheduled) clinic visits.
Methemoglobin assessments will be performed at baseline and Day 8.
Various efficacy assessments will explore the impact of RD-X19 treatment on the reduction in log10 SARS-CoV-2 viral load and alleviation of symptoms associated with COVID-19. Both the magnitude of reduction as a function of dose as well as time to clearance will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will be conducted as a randomized, double-blind, sham-controlled study in SARS-CoV-2 infected individuals with outpatient COVID-19. Subjects will be randomized 2:1 RD-X19 to Sham Device treatment arms.
| Arm | Type | Receives |
|---|---|---|
| RD-X19 Device | Experimental | Device: RD-X19Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens. |
| Sham Device | Sham comparator | Device: RD-X19Investigational 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 (9 listed)
- Positive for SARS-CoV-2 antigen via nasal swab at or within the past 24 hours of the screening visit detected using an FDA authorized SARS-CoV-2 antigen test.
- Onset of signs and symptoms consistent with COVID-19* no longer than within the past 3 days* and have either a) a fever of at least 100 °F or b) at least two moderate or severe symptoms (cough, sore throat, nasal congestion, headache, chills/sweats, muscle or joint pain, fatigue, and nausea) at the time of screening.
- 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 nasopharyngeal swabs, oropharyngeal swabs, oral saliva specimen collection and venous blood specimens per protocol.
Key exclusion criteria (15 listed)
- Positive urine pregnancy test at screening.
- Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
- Presence of self-reported or medically documented uncontrolled significant medical or psychiatric condition(s) other than COVID-19.
- Reports a recent positive test result (within the past 6 months) for hepatitis B surface antigen, 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.
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-X19Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens. | Device | RD-X19 Device, Sham Device |
Primary outcome
Primary Safety Measure
Time frame: Baseline thru Day 8
Number of Participants with device-related serious adverse events or any patterns of severity ≥2 device-related adverse events in the same SOC grouping of Preferred Terms based on Medical Dictionary for Regulatory Activities (MedDRA) coding, as determined throughout the course of the study.
Primary Efficacy Measure
Time frame: Baseline to Day 8
Time weighted average change in viral load from baseline by RT-qPCR from Day 1 to Day 8.
2 secondary outcomes
Proportion of Subjects Demonstrating Clearance of Viral Infection
Time frame: Days 1, 3, 5 and 8
Median Time to Alleviation of Symptoms
Time frame: Daily through day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- 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.
EB-P12-01 Study Director study director
EmitBio
2 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 2 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 9 inclusion and 15 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 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 8 Sep 2022). 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?
Primary Safety Measure (time frame: Baseline thru Day 8). 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 8 Sep 2022.