COVID-19NCT05817045
Evaluation of the RD-X19 Treatment Device in Individuals With Mild COVID-19
A study testing RD-X19 in people with COVID-19, run by EmitBio Inc. at 48 sites in United States.
Trial summary
This is a randomized, double-blind, sham controlled, stratified, pivotal efficacy and safety study of the EmitBio RD-X19 treatment device in Individuals 40 Years of age and older with Mild COVID-19 in the at-home setting. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COVID-19
- 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
- 330 participants
- Where
- 48 sitesUnited States
- Study dates
- 21 Apr 2023to 30 Jun 2024
- 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 40 years and older
- 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 the screening/baseline visit.
- Negative for Influenza A and B antigen using an FDA-authorized rapid diagnostic test.
- At least two moderate or greater COVID-19 signs and symptoms from the following list: cough, sore throat, nasal congestion, headache, chills and/or sweats, myalgia, fatigue, nausea (with or without vomiting) or one moderate or greater symptom and fever (temperature ≥ 100.5 degrees F).
- Time from appearance of first COVID-19 sign or symptom to screening must be 72 hours or less.
- Males or females, including pregnant and fecund females, 40 years of age and older on the date of enrollment.
- BMI <40
Show all 15Show fewer
- 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 collection of a nasopharyngeal swab for qPCR at baseline for the purposes of assessing viral burden as a potential covariate in data analyses and for genetic sequencing to characterize the predominant SARS-CoV-2 variants present in the study population.
- Agrees to perform self-diagnostic home testing twice a day, separated by ≥ 6 hours for the entire length of the study.
- Agrees to restrict medications used for symptomatic relief of signs and symptoms of COVID-19 during the study period, and, if used, to report ALL such medications (including home remedies) to the study staff.
- Agrees to avoid the use of oral rinses and toothpastes containing alcohol-based compounds (e.g. Eucalyptol, Menthol, Thymol, Phenol) and/or Salicylates during the study period. Oral rinses, breath fresheners and toothpaste not containing these compounds are allowed.
- Agrees to avoid nasal and sinus saline lavage during the study period.
- No uncontrolled disease process (chronic or acute), other than COVID-19 signs and symptoms (See section 8.1.1 - General Screening)*.
- 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 for Influenza A and B antigen using an FDA-authorized rapid diagnostic test.
- Individuals < age 40 on study day 1.
- Individuals who are symptomatic for COVID-19 for more than 72 hours on study day 1.
- COVID-19 signs associated with moderate or greater disease with evidence of lower respiratory involvement including shortness of breath (SOB) at rest or as determined by an exertional SOB protocol, SpO2 ≤94, respiratory rate ≥20 breaths per minute, heart rate ≥90 beats per minute, or abnormal pulmonary imaging.
- Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
- History of use of a rescue inhaler for uncontrolled asthma within one month of study day 1.
Show all 18Show fewer
- History of recurrent alcohol intoxication or other recreational drug use (excluding medically prescribed cannabis) within one month of study day 1.
- History of use, within one month of study day 1, of any FDA-authorized treatment for COVID-19. Use of non-approved putative therapies for COVID-19 (hyroxycholorquine, ivermectin, azithromycin) must be discontinued prior to enrollment in the study.
- History of any systemic antiviral therapies within one month of study day 1.
- History of oral or parenteral corticosteroid use within one month of study day 1. Active use of nasal or inhalable steroids 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 one month of study day 1.
- Requirement to use narcotic medication for analgesia.
- History of vasomotor rhinitis with or without post-nasal drip within one month of study day 1.
- 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, symptomatic 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), Temporomandibular Joint 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.
- 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.
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
United States48 sites
340 - Premier Family Medical/CCT Research
American Fork, Utah, 84003
312 - Smart Cures Clinical Research
Anaheim, California, 92806
323 - Annapolis Internal Medicine/CCT Research
Annapolis, Maryland, 21401
338 - Carolina Internal Medicine Associates
Asheville, North Carolina, 28803
343 - Cope Family Medicine/ CCT Research
Bountiful, Utah, 84010
349 - Chicago Medical Research
Chicago, Illinois, 60429
333 - Prime Global Research Inc.
Chicago, Illinois, 60462
331 - Chicago Clinical Research Institute
Chicago, Illinois, 60607
304 - WellNow - Cincinnati
Cincinnati, Ohio, 45215
313 - Benchmark Southern California
Colton, California, 92324
301 - WellNow - Columbus
Columbus, Ohio, 43214
303 - WellNow - Huber Heights
Dayton, Ohio, 45424
315 - Revival Research Institute - Dearborn
Dearborn, Michigan, 48126
302 - WellNow - East Amherst
East Amherst, New York, 14051
334 - Medical Care/CCT Research
Elizabethton, Tennessee, 37643
344 - Skyline Medical Center/ CCT Research
Elkhorn, Nebraska, 68022
308B - Kurr Research @ Complete Health Partners
Hendersonville, Tennessee, 37075
305 - Indago Research and Health Center
Hialeah, Florida, 33012
330 - Clinical Trial Network
Houston, Texas, 77074
335 - Clay Platte Family Medicine/CCT Research
Kansas City, Missouri, 64151
319 - Helios Clinical Research - Keller
Keller, Texas, 76248
321 - Helios Clinical Research - Kissimmee
Kissimmee, Florida, 34744
310 - Accel Research Sites - St. Petersburg
Largo, Florida, 33777
326 - Healor Primary Care
Las Vegas, Nevada, 89102
325 - Santa Rosa Medical Centers of Nevada / CCT Research
Las Vegas, Nevada, 89119
341 - Lifeline Primary Care / CCT Research
Lilburn, Georgia, 30047
307 - Ark Clinical Research
Long Beach, California, 90815
322 - Desert Clinical Research/CCT Research
Mesa, Arizona, 85213
346 - Benchmark Research
Metairie, Louisiana, 70006
306 - Miami Clinical Research
Miami, Florida, 33155
308 - Kur Research @Complete Health Partners
Nashville, Tennessee, 37209
316 - WellNow - Niskayuna
Niskayuna, New York, 12304
329 - Valley Clinical Trials
Northridge, California, 91325
318 - Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654
347 - Velocity Clinical Research
Phoenix, Arizona, 85006
320 - M3 Wake Research
Raleigh, North Carolina, 27612
324 - Advanced Primary and Geriatric Care / CCT Research
Rockville, Maryland, 28050
342 - Ogden Clinical, Grand View/CCT Research
Roy, Utah, 84067
339 - Olympus Family Medicine/CCT
Salt Lake City, Utah, 84117
348 - San Francisco Research Institute
San Francisco, California, 94127
327 - The Research Institute
Springfield, Massachusetts, 01105
336 - St. Louis Medical Professional/CCT Research
St Louis, Missouri, 63119
314 - Revival Research Institute - Sterling Heights
Sterling Heights, Michigan, 48312
332 - Prime Global Research Inc.
The Bronx, New York, 10456
337 - Versailles Family Medicine/CCT Research
Versailles, Kentucky, 40383
309 - Tranquility Clinical Research
Webster, Texas, 77598
345 - The Iowa Clinic/Avacare Legacy
West Des Moines, Iowa, 50266
328 - Mills Clinical Research
West Hollywood, California, 90046
About this study
Official title: A Randomized, Double-Blind, Sham Controlled, Stratified, Pivotal Efficacy and Safety Study of the EmitBio RD-X19 Treatment Device in Individuals 40 Years of Age and Older With Mild COVID-19 in the At-Home Setting
This is a randomized, double-blind, sham controlled, stratified, pivotal efficacy and safety study of the EmitBio RD-X19 treatment device in Individuals 40 Years of age and older with Mild COVID-19 in the at-home setting.
Read the detailed description
This is a randomized, double-blind, sham controlled, stratified, pivotal efficacy and safety study of the EmitBio RD-X19 device in individuals age 40 and older with mild COVID-19 (as defined by NIH and FDA) in the at-home setting. Study subjects will self-administer treatment twice daily, 5 minutes per treatment for 7 consecutive days. Subjects will remain on study for a total of 14 study days (± 2 days) for treatment and follow-up. Neither study subject nor clinical trial personnel will be aware of the subject's treatment assignment. Clinical safety and efficacy outcomes will be assessed via self-assessed signs and symptoms (e-diary entries twice a day during the entire study period) with daily study staff checks, including home visits, and/or clinic visits for objective clinical assessments (vital signs, targeted physical exams, oropharyngeal exams) on study days 1, 5, 8 and 14.
The primary goal of the study is to evaluate the safety and efficacy of the RD-X19 treatment device to provide sufficient evidence to FDA to justify the authorization and/or approval of the device for treatment of subjects with mild COVID-19, age 40 and older in the home setting. Every attempt will be made to continue to follow safety in any study subject choosing to terminate the study early and all study subjects who progress to moderate or more severe forms of COVID-19 will be immediately referred for appropriate medical care. Medically necessary care of study participants will always take precedence over research.
- Conditions
- COVID-19
- 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 |
|---|---|---|
| Active | Active comparator | RD-X19 Active Device
Investigational device that uses 32 J/cm2 of electromagnetic energy to target the oropharynx. Receives: Device: RD-X19 |
| Sham | Sham comparator | RD-X19 Sham Device
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV2 in vitro. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Sustained Resolution of COVID-19 Signs and Symptoms Without Subsequent Symptom Recurrence or Disease Progression (Until the End of the Study)
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 that are hospitalized will be censored at 360 hours, which corresponds to the end of the time window for the day 14. A subject not satisfying case (i) or (ii), who takes nirmatrelvir/ritonavir or molnupiravir after initiating study treatment will be censored at the time that they first took this antiviral medication. Subjects not satisfying case (i), (ii), or (iii) will be censored at the last time that they have e-diary data recorded.
Measured: Baseline through Day 14
Kaplan-Meier Estimates for Time to Sustained Resolution of COVID-19 Signs and Symptoms Without Subsequent Symptom Recurrence or Disease Progression (Until the End of the Study) Full Analysis Set (FAS)
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 that are hospitalized will be censored at 360 hours, which corresponds to the end of the time window for the day 14 visit. A subject not satisfying case (i) or (ii), who takes nirmatrelvir/ritonavir or molnupiravir after initiating study treatment will be censored at the time that they first took this antiviral medication. Subjects not satisfying case (i), (ii), or (iii) will be censored at the last time that they have e-diary data recorded.
Measured: Baseline through Day 14
Secondary outcomes (2)
Number of Subjects With Two Negative SARS-CoV-2 Antigen Tests (With a Minimum Time Between Tests of Six Hours) Without Subsequent Virological Rebound During the Subject's Remaining Time on Study
Number of subjects with two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound during the subject's remaining time on study. Subjects that are hospitalized will be censored at 360 hours, which corresponds to the end of the time window for the day 14 visit. A subject not satisfying case (i) or (ii), who takes nirmatrelvir/ritonavir or molnupiravir after initiating study treatment will be censored at the time that they first took this antiviral medication. Subjects not satisfying case (i), (ii), or (iii) will be censored at the last time that they have e-diary data recorded
Measured: Baseline through Day 14
Kaplan-Meier Estimates Time to First of Two Negative SARS-CoV-2 Antigen Tests
time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virologic rebound (during the subject's remaining time on study) Full Analysis Set (FAS)
Measured: Baseline through Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start21 Apr 2023
- Primary completion15 Jun 2024
- Study completion30 Jun 2024
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 COVID-19Studies 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 1:1 ratio according to a fixed schedule via a permuted block design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- EmitBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director EB-P30-01, Study director, EmitBio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817045
- Sponsor's protocol ID
- EB-P30-01
- Status last verified
- Oct 2024
- First submitted
- 14 Apr 2023
- Last updated
- 24 Oct 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 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Sham Controlled, Stratified, Pivotal Efficacy and Safety Study of the EmitBio RD-X19 Treatment Device in Individuals 40 Years of Age and Older With Mild COVID-19 in the At-Home Setting
- ClinicalTrials.gov ID
- NCT05817045
- Acronym / sponsor ID
- EB-P30-01
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- EmitBio Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Posted 24 Oct 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, double-blind, sham controlled, stratified, pivotal efficacy and safety study of the EmitBio RD-X19 treatment device in Individuals 40 Years of age and older with Mild COVID-19 in the at-home setting.
Detailed description
This is a randomized, double-blind, sham controlled, stratified, pivotal efficacy and safety study of the EmitBio RD-X19 device in individuals age 40 and older with mild COVID-19 (as defined by NIH and FDA) in the at-home setting. Study subjects will self-administer treatment twice daily, 5 minutes per treatment for 7 consecutive days. Subjects will remain on study for a total of 14 study days (± 2 days) for treatment and follow-up. Neither study subject nor clinical trial personnel will be aware of the subject's treatment assignment. Clinical safety and efficacy outcomes will be assessed via self-assessed signs and symptoms (e-diary entries twice a day during the entire study period) with daily study staff checks, including home visits, and/or clinic visits for objective clinical assessments (vital signs, targeted physical exams, oropharyngeal exams) on study days 1, 5, 8 and 14.
The primary goal of the study is to evaluate the safety and efficacy of the RD-X19 treatment device to provide sufficient evidence to FDA to justify the authorization and/or approval of the device for treatment of subjects with mild COVID-19, age 40 and older in the home setting. Every attempt will be made to continue to follow safety in any study subject choosing to terminate the study early and all study subjects who progress to moderate or more severe forms of COVID-19 will be immediately referred for appropriate medical care. Medically necessary care of study participants will always take precedence over research.
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
- 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 1:1 ratio according to a fixed schedule via a permuted block design.
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: RD-X19RD-X19 Active Device Investigational device that uses 32 J/cm2 of electromagnetic energy to target the oropharynx. |
| Sham | Sham comparator | Device: ShamRD-X19 Sham Device Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV2 in vitro. |
Who may qualify
- Ages
- 40 years and older
- 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 the screening/baseline visit.
- Negative for Influenza A and B antigen using an FDA-authorized rapid diagnostic test.
- At least two moderate or greater COVID-19 signs and symptoms from the following list: cough, sore throat, nasal congestion, headache, chills and/or sweats, myalgia, fatigue, nausea (with or without vomiting) or one moderate or greater symptom and fever (temperature ≥ 100.5 degrees F).
- Time from appearance of first COVID-19 sign or symptom to screening must be 72 hours or less.
- Males or females, including pregnant and fecund females, 40 years of age and older on the date of enrollment.
Key exclusion criteria (18 listed)
- Positive for Influenza A and B antigen using an FDA-authorized rapid diagnostic test.
- Individuals < age 40 on study day 1.
- Individuals who are symptomatic for COVID-19 for more than 72 hours on study day 1.
- COVID-19 signs associated with moderate or greater disease with evidence of lower respiratory involvement including shortness of breath (SOB) at rest or as determined by an exertional SOB protocol, SpO2 ≤94, respiratory rate ≥20 breaths per minute, heart rate ≥90 beats per minute, or abnormal pulmonary imaging.
- Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
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 | Active |
| 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 |
Primary outcome
Number of Subjects With Sustained Resolution of COVID-19 Signs and Symptoms Without Subsequent Symptom Recurrence or Disease Progression (Until the End of the Study)
Time frame: Baseline through 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 that are hospitalized will be censored at 360 hours, which corresponds to the end of the time window for the day 14. A subject not satisfying case (i) or (ii), who takes nirmatrelvir/ritonavir or molnupiravir after initiating study treatment will be censored at the time that they first took this antiviral medication. Subjects not satisfying case (i), (ii), or (iii) will be censored at the last time that they have e-diary data recorded.
Kaplan-Meier Estimates for Time to Sustained Resolution of COVID-19 Signs and Symptoms Without Subsequent Symptom Recurrence or Disease Progression (Until the End of the Study) Full Analysis Set (FAS)
Time frame: Baseline through 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 that are hospitalized will be censored at 360 hours, which corresponds to the end of the time window for the day 14 visit. A subject not satisfying case (i) or (ii), who takes nirmatrelvir/ritonavir or molnupiravir after initiating study treatment will be censored at the time that they first took this antiviral medication. Subjects not satisfying case (i), (ii), or (iii) will be censored at the last time that they have e-diary data recorded.
2 secondary outcomes
Number of Subjects With Two Negative SARS-CoV-2 Antigen Tests (With a Minimum Time Between Tests of Six Hours) Without Subsequent Virological Rebound During the Subject's Remaining Time on Study
Time frame: Baseline through Day 14
Kaplan-Meier Estimates Time to First of Two Negative SARS-CoV-2 Antigen Tests
Time frame: Baseline through Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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 EB-P30-01 study director
EmitBio
48 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 COVID-19, run by EmitBio Inc. at 48 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 18 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 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 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 24 Oct 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?
Number of Subjects With Sustained Resolution of COVID-19 Signs and Symptoms Without Subsequent Symptom Recurrence or Disease Progression (Until the End of the Study) (time frame: Baseline through 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 24 Oct 2024.