Post COVID-19 Condition (PCC)EB-PCC-01NCT06113679
Pilot Randomized Study of RD-X19 Tx Device in Subjects With PCC (Long Covid) in the Outpatient Setting
A study testing RDX-19 in people with Post COVID-19 Condition (PCC), run by EmitBio Inc. at 2 sites in United States.
Trial summary
Duration of Treatment: 7 days, 2 times per day. Following Randomization on Week 1 Day 1, Subjects will continue to have televisits and rate symptoms and upright activity weekly during a 5 week follow up. Subjects will be followed via in clinic visits at week 2/day 8 (+3/-0 days) and Week 6 / day 36, (+3/-3days). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Post COVID-19 Condition (PCC)
- What is being tested?
- RDX-19
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Oct 2023to 21 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject must meet all the following criteria to be eligible for inclusion in this study:
- History of confirmed diagnosis of SARS-CoV-2 infection or COVID-19 per section 9.4.
- PCC (per protocol definition) with cough and at least 2 of the 3 additional qualifying symptoms that have been determined not associated with another disease state:
- fatigue
- shortness of breath
- cognitive dysfunction/brain fog.
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- Negative for COVID-19 via rapid antigen test.
- Minimum time period from onset of symptoms (or from date of positive test for asymptomatic) - 3 months.
- Minimum duration of symptoms at least 2 months, continuous or intermittent.
- Males or females, 22 years of age and older on the date of enrollment.
- Provides written informed consent prior to initiation of any study procedures.
- Be able to understand and agrees to fully comply with defined and described study procedures and be available for all study visits for the entire study duration.
- Agrees to perform self-treatment twice a day, separated by ≥ 6 hours during the treatment period.
- Agrees to maintain current medications without the addition of any new medications for relief of signs and symptoms of PCC during the entire study period, and, if used, to report ALL such medications (including over the counter and home remedies) to the study staff.
- No uncontrolled disease process (chronic or acute) that could be attributable to qualifying 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.
- For women of childbearing potential, a negative urine pregnancy test at screening. Subjects (female subjects of childbearing potential and male subjects with partners of childbearing potential) must agree to use proper** contraceptive methods to avoid pregnancy during the study.
Who cannot join
- A subject with any of the following criteria will be excluded from participation in this study:
- Positive test for SARS-CoV-2 infection or COVID-19 within the past 30 days.
- Individuals < age 22 at consent.
- Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
- History of recurrent alcohol intoxication or other recreational drug use (excluding medically prescribed cannabis) within 30 days of study day, V1.
- History of any systemic antiviral therapies within 30 days of study day, V1.
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- History of oral or parenteral corticosteroid use within 30 days of study day, V1. Active use of nasal or inhalable corticosteroids is also exclusionary. Topical steroids are not exclusionary.
- History of any chronic medical condition that has required adjustments to the type, dose, or schedule of medical treatments within 30 days of study day, V1.
- Requirement to use narcotic medication for analgesia.
- History of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to sun exposure.
- Presence of any oral abnormality (e.g., including, but not limited to, ulcer, oral candidiasis, oral mucositis, gingivitis, history of frequent recurrent aphthous ulcers, burning mouth syndrome, dry mouth syndrome, a disease that can result in xerostomia (e.g., Sjogren's syndrome), or other oral disorder that in the opinion of the investigator would interfere with device use and evaluation.
- Any 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.
- Any individual without teeth or with a dental malformation that precludes directed use of the device as intended.
- Use of new medications to treat PCC symptoms within the 30 days prior to V1.
- Currently enrolled in or plans to participate in another clinical trial with a therapeutic investigational agent for any medical indication that will be received during the study period.
- Has participated in an investigational treatment trial for PCC within the past 30 days.
- Subjects with immunodeficiency syndromes, including HIV, per medical history diagnosed prior to previous acute COVID-19.
- Subjects who have previously participated in RD-X19 acute studies, P20 or P30.
- Is pregnant or nursing, is not post-menopausal, or is not currently on birth control. The rhythm method is not an acceptable form of birth control for this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Site 2_WellNow Urgent Care and Research
East Amherst, New York, 14051
Site 1_Helios - Physician Quality Care
Milan, Tennessee, 38358
About this study
Official title: EB-PCC-01, A Pilot Randomized, Sham Controlled Safety and Efficacy Study of the EmitBio™ RD-X19 Treatment Device in Subjects With Post COVID-19 Condition (PCC) in the Outpatient Setting
Duration of Treatment: 7 days, 2 times per day.
Following Randomization on Week 1 Day 1, Subjects will continue to have televisits and rate symptoms and upright activity weekly during a 5 week follow up. Subjects will be followed via in clinic visits at week 2/day 8 (+3/-0 days) and Week 6 / day 36, (+3/-3days). Subjects will receive a weekly televisit during Week 3 / day 15 (+3/-3), Week 4 / day 22 (+3/-3), and Week 5 / day 29 (+3/-3).
Read the detailed description
Subjects who have been pre-screened will be approached regarding the study and scheduled for a Screening Visit (V0). During the Screening Visit (V0) subjects will be consented and screened. To be considered eligible, subjects must present evidence of prior SARS-CoV-2 infection or COVID-19 via in clinic testing. Subject screening will include symptom assessments, medical history, and collection of laboratory samples. Following receipt of subject lab results, subjects who meet inclusion/exclusion criteria will be scheduled for Visit 1. At V1 eligible subjects will be randomized 1:1 to receive device or sham. Randomization will be performed.
During V1 which is Day 1 of treatment, subjects will receive in clinic training on the use of the device. Subjects will administer the first treatment while supervised in the clinic. The second treatment on Day 1 will be at home via a televisit performed by eligible clinical site staff.
At V1 subjects will identify and grade symptoms on a 4 point scale for both primary and secondary PCC symptoms. This evaluation will serve as a baseline for subsequent comparative assessments using the Patients Global Impression of Change 1(PGIC-1) scale.
After the first in clinic treatment, subjects will self treat at home during a prescheduled televisit. Televisits may be performed via web based telehealth applications or telephone with eligible clinical site staff. At each televisit, subjects will be asked questions regarding possible side effects and adverse events. Daily during the telehealth visit that occurs during treatment, clinical site staff will assess symptoms using the PGIC 1 scale and will assess their hours of upright activity..
Follow up will be performed for 5 weeks after treatment completion. During follow up telehealth visits subjects will be asked about any symptomswhich will include the PGIC 1 assessment and hours of upright activity.
At follow up week 2 (day 8 +3/- 0 days) subjects will return to the clinic for in person visual and physical health assessments, changes since last visit, safety assessments, and a blood draw. During the in clinic visit the subject will complete the PGIC 1 assessment and hours of upright activity assessment.
During weeks 3, 4, and 5, subjects will be followed via televisits, with each visits cheduled on approximately the same day each week. During the televisits, subjects will be asked questions regarding adverse events, the PGIC-1 assessment and hours of upright activity assessment will be performed..
At follow up week 6 (+/-3 days), subjects will return to the clinic for in person visual and physical health assessments, changes since last visit, safety assessments, and a blood draw. While in clinic, subjects will complete the final PGIC 1 scale, the PGIC 2 scale, and upright activity assessments. The PGIC 2 assessment is additional data not associated with an endpoint. Subjects will return the study devices..
Additional data collected as a part of the study will be the measure of cytokines and chemokines before and after treatment. Hours of upright activity over the course of the study will also be reported.. Both of these assessments are reported measures but are not associated with objectives or endpoints.
- Conditions
- Post COVID-19 Condition (PCC)
- Being tested
- RDX-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDX-19Device
RD-X19 device with a 5 minute, 32 J/cm2 dose, 2X/day, 7 days. Each treatment at least 6 hours apart.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Not described Receives: Device: RDX-19 |
| Sham | Sham comparator | Not described Receives: Device: RDX-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Symptom Improvement
Improvement of one or more primary PCC signs/symptom(s) - cough, fatigue, shortness of breath, cognitive dysfunction/brain fog as compared to sham, with or without fluctuation.
Measured: 5 weeks
Secondary outcomes (1)
Secondary Symptom Improvement
Improvement of one or more secondary PCC signs/symptoms as compared to sham, with or without fluctuation:
- chest pain
- altered smell/taste
- headache
- joint pain
- muscle pain/spasms
- post exertional malaise
- sleep disorders
- tachycardia/palpitations,and
- GI/abdominal symptoms (include but not limited to abdominal pain, nausea, diarrhea, vomiting).
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start30 Oct 2023
- Primary completion24 May 2024
- Study completion21 Jun 2024
Why it stopped: Enrollment stopped by Sponsor following interim analysis data review.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post COVID-19 Condition (PCC)Studies 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
- Parallel groups
- Model description
- Randomized, 1:1 Sham Control
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- EmitBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113679
- Sponsor's protocol ID
- EB-PCC-01
- Other IDs
- Pro00074175
- Acronym
- EB-PCC-01
- Status last verified
- Jul 2024
- First submitted
- 30 Oct 2023
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EB-PCC-01, A Pilot Randomized, Sham Controlled Safety and Efficacy Study of the EmitBio™ RD-X19 Treatment Device in Subjects With Post COVID-19 Condition (PCC) in the Outpatient Setting
- ClinicalTrials.gov ID
- NCT06113679
- Acronym / sponsor ID
- EB-PCC-01 / EB-PCC-01
- Conditions
- Post COVID-19 Condition (PCC)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment stopped by Sponsor following interim analysis data review.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- EmitBio Inc.Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Duration of Treatment: 7 days, 2 times per day.
Following Randomization on Week 1 Day 1, Subjects will continue to have televisits and rate symptoms and upright activity weekly during a 5 week follow up. Subjects will be followed via in clinic visits at week 2/day 8 (+3/-0 days) and Week 6 / day 36, (+3/-3days). Subjects will receive a weekly televisit during Week 3 / day 15 (+3/-3), Week 4 / day 22 (+3/-3), and Week 5 / day 29 (+3/-3).
Detailed description
Subjects who have been pre-screened will be approached regarding the study and scheduled for a Screening Visit (V0). During the Screening Visit (V0) subjects will be consented and screened. To be considered eligible, subjects must present evidence of prior SARS-CoV-2 infection or COVID-19 via in clinic testing. Subject screening will include symptom assessments, medical history, and collection of laboratory samples. Following receipt of subject lab results, subjects who meet inclusion/exclusion criteria will be scheduled for Visit 1. At V1 eligible subjects will be randomized 1:1 to receive device or sham. Randomization will be performed.
During V1 which is Day 1 of treatment, subjects will receive in clinic training on the use of the device. Subjects will administer the first treatment while supervised in the clinic. The second treatment on Day 1 will be at home via a televisit performed by eligible clinical site staff.
At V1 subjects will identify and grade symptoms on a 4 point scale for both primary and secondary PCC symptoms. This evaluation will serve as a baseline for subsequent comparative assessments using the Patients Global Impression of Change 1(PGIC-1) scale.
After the first in clinic treatment, subjects will self treat at home during a prescheduled televisit. Televisits may be performed via web based telehealth applications or telephone with eligible clinical site staff. At each televisit, subjects will be asked questions regarding possible side effects and adverse events. Daily during the telehealth visit that occurs during treatment, clinical site staff will assess symptoms using the PGIC 1 scale and will assess their hours of upright activity..
Follow up will be performed for 5 weeks after treatment completion. During follow up telehealth visits subjects will be asked about any symptomswhich will include the PGIC 1 assessment and hours of upright activity.
At follow up week 2 (day 8 +3/- 0 days) subjects will return to the clinic for in person visual and physical health assessments, changes since last visit, safety assessments, and a blood draw. During the in clinic visit the subject will complete the PGIC 1 assessment and hours of upright activity assessment.
During weeks 3, 4, and 5, subjects will be followed via televisits, with each visits cheduled on approximately the same day each week. During the televisits, subjects will be asked questions regarding adverse events, the PGIC-1 assessment and hours of upright activity assessment will be performed..
At follow up week 6 (+/-3 days), subjects will return to the clinic for in person visual and physical health assessments, changes since last visit, safety assessments, and a blood draw. While in clinic, subjects will complete the final PGIC 1 scale, the PGIC 2 scale, and upright activity assessments. The PGIC 2 assessment is additional data not associated with an endpoint. Subjects will return the study devices..
Additional data collected as a part of the study will be the measure of cytokines and chemokines before and after treatment. Hours of upright activity over the course of the study will also be reported.. Both of these assessments are reported measures but are not associated with objectives or endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, 1:1 Sham Control
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: RDX-19 |
| Sham | Sham comparator | Device: RDX-19 |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- A subject must meet all the following criteria to be eligible for inclusion in this study:
- History of confirmed diagnosis of SARS-CoV-2 infection or COVID-19 per section 9.4.
- PCC (per protocol definition) with cough and at least 2 of the 3 additional qualifying symptoms that have been determined not associated with another disease state:
- Negative for COVID-19 via rapid antigen test.
- Minimum time period from onset of symptoms (or from date of positive test for asymptomatic) - 3 months.
Key exclusion criteria (19 listed)
- A subject with any of the following criteria will be excluded from participation in this study:
- Positive test for SARS-CoV-2 infection or COVID-19 within the past 30 days.
- Individuals < age 22 at consent.
- Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
- History of recurrent alcohol intoxication or other recreational drug use (excluding medically prescribed cannabis) within 30 days of study day, V1.
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 |
|---|---|---|
| RDX-19RD-X19 device with a 5 minute, 32 J/cm2 dose, 2X/day, 7 days. Each treatment at least 6 hours apart. | Device | Active, Sham |
Primary outcome
Primary Symptom Improvement
Time frame: 5 weeks
Improvement of one or more primary PCC signs/symptom(s) - cough, fatigue, shortness of breath, cognitive dysfunction/brain fog as compared to sham, with or without fluctuation.
1 secondary outcome
Secondary Symptom Improvement
Time frame: 5 weeks
Results and safety
The study was stopped early (reason given: Enrollment stopped by Sponsor following interim analysis data review.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RDX-19 in people with Post COVID-19 Condition (PCC), 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 17 inclusion and 19 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: stopped early, as of the sponsor's last update on 5 Jul 2024. 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?
The study was stopped early (reason given: Enrollment stopped by Sponsor following interim analysis data review.). Results are not available in the source record.
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 Symptom Improvement (time frame: 5 weeks). 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 5 Jul 2024.