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CompletedNCT05817045Updated Oct 24, 2024Results posted

Evaluation of the RD-X19 Treatment Device in Individuals With Mild COVID-19

An interventional study of RD-X19 and Sham in COVID-19, sponsored by EmitBio Inc.. Completed at 48 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-10-24.

Sponsored by EmitBio Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
330
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • COVID-19

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03

In context

COVID-19

7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 330 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

EmitBio Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Positive for SARS-CoV-2 as detected using an FDA authorized SARS-CoV-2 antigen test at the screening/baseline visit.
  2. Negative for Influenza A and B antigen using an FDA-authorized rapid diagnostic test.
  3. 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).
  4. Time from appearance of first COVID-19 sign or symptom to screening must be 72 hours or less.
  5. Males or females, including pregnant and fecund females, 40 years of age and older on the date of enrollment.
  6. BMI \<40
  7. Provides written informed consent prior to initiation of any study procedures.
  8. 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.
  9. 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.
  10. Agrees to perform self-diagnostic home testing twice a day, separated by ≥ 6 hours for the entire length of the study.
  11. 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.
  12. 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.
  13. Agrees to avoid nasal and sinus saline lavage during the study period.
  14. No uncontrolled disease process (chronic or acute), other than COVID-19 signs and symptoms (See section 8.1.1 - General Screening)*.
  15. 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.

Exclusion criteria

Exclusion Criteria:

  1. Positive for Influenza A and B antigen using an FDA-authorized rapid diagnostic test.
  2. Individuals \< age 40 on study day 1.
  3. Individuals who are symptomatic for COVID-19 for more than 72 hours on study day 1.
  4. 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.
  5. Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
  6. History of use of a rescue inhaler for uncontrolled asthma within one month of study day 1.
  7. History of recurrent alcohol intoxication or other recreational drug use (excluding medically prescribed cannabis) within one month of study day 1.
  8. 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.
  9. History of any systemic antiviral therapies within one month of study day 1.
  10. 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.
  11. 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.
  12. Requirement to use narcotic medication for analgesia.
  13. History of vasomotor rhinitis with or without post-nasal drip within one month of study day 1.
  14. History of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to sun exposure.
  15. 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.
  16. 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.
  17. Any individual without teeth or with a dental malformation that precludes directed use of the device as intended.
  18. 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
330 participants (actual)

Study arms

  • Active comparator
    Active

    RD-X19 Active Device Investigational device that uses 32 J/cm2 of electromagnetic energy to target the oropharynx.

    Device: RD-X19

  • Sham comparator
    Sham

    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.

    Device: Sham

Interventions

  • DeviceRD-X19

    Investigational device that uses safe electromagnetic energy to target the oropharynx.

  • DeviceSham

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline through Day 14

  2. 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.

    Time frame: Baseline through Day 14

Secondary outcomes

  1. 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

    Time frame: Baseline through Day 14

  2. 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)

    Time frame: Baseline through Day 14

Other outcomes

  1. Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)

    The following are secondary qualitative measures (each taking the values yes, no) recorded at the post-baseline clinic visits for COVID-related assessment: In the past 24 hours, have you returned to your usual health (before your COVID-19 illness)? In the past 24 hours, have you returned to your usual activities (before your COVID-19 illness)?

    Time frame: Baseline, Day 5, Day 8, and Day 14 or Early Termination Visit

07

Results

Posted Oct 24, 2024

Participant flow

Participant flow — Overall Study
MilestoneActiveSham
Started162168
Completed147157
Not completed1511
Withdrew: Protocol violation03
Withdrew: Withdrawal by subject107
Withdrew: Physician decision30
Withdrew: Lost to follow-up01
Withdrew: Device deficiency10
Withdrew: System error10

Outcome measures

PrimaryNumber 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.

Time frame:
Baseline through Day 14
Reported as:
Count of participants · Participants
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)
ParticipantsActiveSham
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)107120
Statistical analysis
  • Active vs Sham · NPANCOVA · p = 0.948 · Hazard ratio (hr): 1.01 · 95% CI 0.777 to 1.310For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19
  • Active vs Sham · NPANCOVA · p = 0.902 (adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score.) · Hazard ratio (hr): 1.02 · 95% CI 0.774 to 1.337For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19
  • Active vs Sham · NPANCOVA · p = 0.859 · Hazard ratio (hr): 1.02 · 95% CI 0.782 to 1.342For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19;
PrimaryKaplan-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.

Time frame:
Baseline through Day 14
Reported as:
Number · hours
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)
hoursActiveSham
25th percentile for time to sustained resolution44.22 (26.628 to 64.440)62.49 (41.338 to 70.551)
Median time to sustained resolution100.36 (80.264 to 137.830)113.39 (89.617 to 140.690)
75th percentile for time to sustained resolutionNA (209.970 to NA)261.35 (205.188 to NA)
SecondaryNumber 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

Time frame:
Baseline through Day 14
Reported as:
Count of participants · Participants
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
ParticipantsActiveSham
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 Study146157
Statistical analysis
  • Active vs Sham · NPANCOVA · p = 0.017 · Hazard ratio (hr): 1.29 · 95% CI 1.047 to 1.596For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19
  • Active vs Sham · NPANCOVA · p = 0.014 · Hazard ratio (hr): 1.33 · 95% CI 1.059 to 1.665For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19;
  • Active vs Sham · NPANCOVA · p = 0.007 · Hazard ratio (hr): 1.35 · 95% CI 1.086 to 1.690For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19
  • Active vs Sham · Cox proportional hazard: 1.46 · 95% CI 1.064 to 1.997For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19
  • Active vs Sham · Cox proportional hazard: 1.12 · 95% CI 0.801 to 1.561For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19
SecondaryKaplan-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)

Time frame:
Baseline through Day 14
Reported as:
Number · hours
Kaplan-Meier Estimates Time to First of Two Negative SARS-CoV-2 Antigen Tests
hoursActiveSham
25th percentile for time to first of two negative SARS-CoV-2 tests47.02 (41.241 to 60.457)52.89 (40.966 to 66.051)
Median time to first of two negative SARS-CoV-2 tests74.58 (70.741 to 87.604)87.97 (75.473 to 96.581)
75th percentile for time to first of two negative SARS-CoV-2 tests111.18 (100.228 to 121.916)133.42 (114.496 to 144.960)
Other pre-specifiedSecondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)

The following are secondary qualitative measures (each taking the values yes, no) recorded at the post-baseline clinic visits for COVID-related assessment: In the past 24 hours, have you returned to your usual health (before your COVID-19 illness)? In the past 24 hours, have you returned to your usual activities (before your COVID-19 illness)?

Time frame:
Baseline, Day 5, Day 8, and Day 14 or Early Termination Visit
Reported as:
Count of participants · Participants
Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)
ParticipantsActiveSham
Returned to usual health in past 24 hours (Day 5 visit) — Yes4848
Returned to usual health in past 24 hours (Day 5 visit) — No96108
Returned to usual health in past 24 hours (Day 5 visit) — Missing12
Returned to usual health in past 24 hours (Day 8 visit) — Yes97100
Returned to usual health in past 24 hours (Day 8 visit) — No4654
Returned to usual health in past 24 hours (Day 8 visit) — Missing44
Returned to usual health in past 24 hours (Day 14/ET visit) — Yes129132
Returned to usual health in past 24 hours (Day 14/ET visit) — No2322
Returned to usual health in past 24 hours (Day 14/ET visit) — Missing24
Returned to usual activities in past 24 hours (Day 5 visit) — Yes6771
Returned to usual activities in past 24 hours (Day 5 visit) — No7785
Returned to usual activities in past 24 hours (Day 5 visit) — Missing12
Returned to usual activities in past 24 hours (Day 8 visit) — Yes115115
Returned to usual activities in past 24 hours (Day 8 visit) — No2838
Returned to usual activities in past 24 hours (Day 8 visit) — Missing45
Returned to usual activities in past 24 hours (Day 14/ET visit) — Yes137138
Returned to usual activities in past 24 hours (Day 14/ET visit) — No1516
Returned to usual activities in past 24 hours (Day 14/ET visit) — Missing24

Adverse events

Collected over 14 days. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Active0/158 (0%)0/158 (0%)18/158 (11.4%)
Sham0/162 (0%)0/162 (0%)12/162 (7.4%)
Most frequent other events
Most frequent other events
EventActiveSham
HeadacheNervous system disorders4/1581/162
Oropharyngeal PainRespiratory, thoracic and mediastinal disorders3/1582/162
Dry MouthGastrointestinal disorders3/1581/162
CoughRespiratory, thoracic and mediastinal disorders3/1581/162
ErythemaSkin and subcutaneous tissue disorders3/1581/162
NauseaGastrointestinal disorders1/1583/162
PharyngitisInfections and infestations1/1583/162

Baseline characteristics

Full Analysis Set (FAS): The Full Analysis Set (FAS) will consist of the set of randomized subjects, excluding: (i) subjects who were mis-randomized; and (ii) subject IDs corresponding to study participants that were re-randomized under a different subject ID.

Age, Continuous
Age, Continuous(years)ActiveShamTotal
Mean54.39 ± 8.79355.56 ± 10.18054.98 ± 9.526
Sex: Female, Male
Sex: Female, Male(Participants)ActiveShamTotal
Female99105204
Male6261123
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)ActiveShamTotal
Hispanic or Latino455398
Not Hispanic or Latino112112224
Unknown or Not Reported415
Race (NIH/OMB)
Race (NIH/OMB)(Participants)ActiveShamTotal
American Indian or Alaska Native213
Asian71017
Native Hawaiian or Other Pacific Islander022
Black or African American383472
White112117229
More than one race224
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)ActiveShamTotal
United States161166327
Body Mass Index (BMI)
Body Mass Index (BMI)(Kg/m^2)ActiveShamTotal
Mean28.9498 ± 5.0118729.5443 ± 4.9295129.2525 ± 4.97137
Total Baseline Disease Severity Score
Total Baseline Disease Severity Score(units on a scale)ActiveShamTotal
Mean1.4977 ± 0.467391.4571 ± 0.457411.4771 ± 0.46209
COVID-19 vaccination status
COVID-19 vaccination status(Participants)ActiveShamTotal
Yes122118240
No384583
Missing134

5 further baseline measures are reported on the registry.

08

Study locations

48 sites
  • 322 - Desert Clinical Research/CCT Research
    Mesa, Arizona 85213, United States
  • 347 - Velocity Clinical Research
    Phoenix, Arizona 85006, United States
  • 312 - Smart Cures Clinical Research
    Anaheim, California 92806, United States
  • 313 - Benchmark Southern California
    Colton, California 92324, United States
  • 307 - Ark Clinical Research
    Long Beach, California 90815, United States
  • 329 - Valley Clinical Trials
    Northridge, California 91325, United States
  • 348 - San Francisco Research Institute
    San Francisco, California 94127, United States
  • 328 - Mills Clinical Research
    West Hollywood, California 90046, United States
  • 305 - Indago Research and Health Center
    Hialeah, Florida 33012, United States
  • 321 - Helios Clinical Research - Kissimmee
    Kissimmee, Florida 34744, United States
  • 310 - Accel Research Sites - St. Petersburg
    Largo, Florida 33777, United States
  • 306 - Miami Clinical Research
    Miami, Florida 33155, United States
  • 341 - Lifeline Primary Care / CCT Research
    Lilburn, Georgia 30047, United States
  • 349 - Chicago Medical Research
    Chicago, Illinois 60429, United States
  • 333 - Prime Global Research Inc.
    Chicago, Illinois 60462, United States
  • 331 - Chicago Clinical Research Institute
    Chicago, Illinois 60607, United States
  • 345 - The Iowa Clinic/Avacare Legacy
    West Des Moines, Iowa 50266, United States
  • 337 - Versailles Family Medicine/CCT Research
    Versailles, Kentucky 40383, United States
  • 346 - Benchmark Research
    Metairie, Louisiana 70006, United States
  • 323 - Annapolis Internal Medicine/CCT Research
    Annapolis, Maryland 21401, United States
  • 324 - Advanced Primary and Geriatric Care / CCT Research
    Rockville, Maryland 28050, United States
  • 327 - The Research Institute
    Springfield, Massachusetts 01105, United States
  • 315 - Revival Research Institute - Dearborn
    Dearborn, Michigan 48126, United States
  • 314 - Revival Research Institute - Sterling Heights
    Sterling Heights, Michigan 48312, United States
  • 318 - Olive Branch Family Medical Center
    Olive Branch, Mississippi 38654, United States
  • 335 - Clay Platte Family Medicine/CCT Research
    Kansas City, Missouri 64151, United States
  • 336 - St. Louis Medical Professional/CCT Research
    St Louis, Missouri 63119, United States
  • 344 - Skyline Medical Center/ CCT Research
    Elkhorn, Nebraska 68022, United States
  • 326 - Healor Primary Care
    Las Vegas, Nevada 89102, United States
  • 325 - Santa Rosa Medical Centers of Nevada / CCT Research
    Las Vegas, Nevada 89119, United States
  • 302 - WellNow - East Amherst
    East Amherst, New York 14051, United States
  • 316 - WellNow - Niskayuna
    Niskayuna, New York 12304, United States
  • 332 - Prime Global Research Inc.
    The Bronx, New York 10456, United States
  • 338 - Carolina Internal Medicine Associates
    Asheville, North Carolina 28803, United States
  • 320 - M3 Wake Research
    Raleigh, North Carolina 27612, United States
  • 304 - WellNow - Cincinnati
    Cincinnati, Ohio 45215, United States
  • 301 - WellNow - Columbus
    Columbus, Ohio 43214, United States
  • 303 - WellNow - Huber Heights
    Dayton, Ohio 45424, United States
  • 334 - Medical Care/CCT Research
    Elizabethton, Tennessee 37643, United States
  • 308B - Kurr Research @ Complete Health Partners
    Hendersonville, Tennessee 37075, United States
  • 308 - Kur Research @Complete Health Partners
    Nashville, Tennessee 37209, United States
  • 330 - Clinical Trial Network
    Houston, Texas 77074, United States
  • 319 - Helios Clinical Research - Keller
    Keller, Texas 76248, United States
  • 309 - Tranquility Clinical Research
    Webster, Texas 77598, United States
  • 340 - Premier Family Medical/CCT Research
    American Fork, Utah 84003, United States
  • 343 - Cope Family Medicine/ CCT Research
    Bountiful, Utah 84010, United States
  • 342 - Ogden Clinical, Grand View/CCT Research
    Roy, Utah 84067, United States
  • 339 - Olympus Family Medicine/CCT
    Salt Lake City, Utah 84117, United States
09

References and documents

Study documents

  • Study protocol · Feb 7, 2024
  • Statistical analysis plan · Mar 25, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2023 to primary completion in Jun 2024, 13 months.

Results were first posted in Oct 2024, 4 months after primary completion.

Of 130 industry-sponsored interventional studies with no phase under COVID-19, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 11. This study's 13 months is above that.

Counting every sponsor, half of 1,425 studies reached it within 9 months; a quarter within 3 and three quarters within 19.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 14, 2023
First posted
Apr 18, 2023
StartActual
Apr 21, 2023
Primary completionActual
Jun 15, 2024
CompletionActual
Jun 30, 2024
Results first posted
Oct 24, 2024
Last update
Oct 24, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05817045
Lead sponsor
EmitBio Inc.
Responsible party
Sponsor
First posted
Apr 18, 2023
Start date
Apr 21, 2023
Primary completion
Jun 15, 2024
Completion
Jun 30, 2024
Results posted
Oct 24, 2024
Last update
Oct 24, 2024

Study contacts

Study Director EB-P30-01
study director · EmitBio

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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