CoronavirusNCT04336215
Rutgers COVID-19 Cohort Study
An observational study of Coronavirus and SARS-CoV-2, run by Rutgers, The State University of New Jersey at 7 sites in United States.
Trial summary
Our long-term goal is to protect the health care workforce (HCW) caring for SARS-CoV-2-infected patients, their families, communities, and the general population. Our specific objective is to rapidly establish a prospective cohort to characterize the factors related to viral transmission and disease severity in a… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus, SARS-CoV-2
- What is being tested?
- Non-Interventional
- How many people
- 829 participants
- Where
- 7 sitesUnited States
- Study dates
- 7 Apr 2020to 31 Aug 2024
- Phase
- Observational
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * HCW from two RBHS hospitals: Robert Wood Johnson University Hospital (RWJUH) in New Brunswick and University Hospital (UH) in Newark ; (both hospital presidents have approved the study) * NHCW from Rutgers faculty, staff, and hospital employees without patient contact;
Who may be able to join
- 20 years and older
- Hospital and RBHS healthcare workers who have regular direct patient contact (≥3 patients/shift) in emergency rooms or inpatient settings that is expected to continue regularly over the next ≥3 months and who work ≥20 hours in the hospital weekly (residents, clinical fellows, attending physicians, nurse practitioners, physician assistants, registered nurses, license practice nurses, medical technicians, respiratory therapists, physical therapists, clinical pharmacists, dentists, dental hygienists, or dental assistants)
- Hospital workers who do not have patient contact and non-healthcare from the Rutgers faculty, postdoctoral students, administrators, and staff.
Who cannot join
- Previous diagnosis with COVID-19
- Pregnant or have been diagnosed with a new medical condition in the past 30 days or have had a change in medications in the past 30 days
- Participants who have been hospitalized in the past 30 days, had and had an emergency room, urgent care visit, or have had surgery.
- Participants who have a fever on the day of their first visit to the study site (for consent, biospecimen collection, etc.).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Clinical Research Center Rutgers-Robert Wood Johnson Medical School RWJUH East Tower -
New Brunswick, New Jersey, 08901
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
Clinical Research Unit Rutgers New Jersey Medical School
Newark, New Jersey, 07103
Rutgers School of Dental Medicine
Newark, New Jersey, 07103
University Hospital
Newark, New Jersey, 07103
Environmental and Occupational Health Sciences Institute
Piscataway, New Jersey, 08854
RUCDR Infinite Biologics
Piscataway, New Jersey, 08854
About this study
Official title: Cohort Study of SARS-CoV-2 Incidence, Transmission, and Disease Severity in Healthcare Workers
Our long-term goal is to protect the health care workforce (HCW) caring for SARS-CoV-2-infected patients, their families, communities, and the general population. Our specific objective is to rapidly establish a prospective cohort to characterize the factors related to viral transmission and disease severity in a large healthcare system. We addressed this hypothesis by recruiting and longitudinally following 546 HCW and a comparison group of 283 non-HCW within a large academic health system, Rutgers Biomedical and Health Sciences (RBHS). By intensively following participants over a several year period (2020-2024) and collecting serial biospecimens (nasopharyngeal/throat swabs, blood, and saliva) and questionnaire data at multiple time points, we will uniquely characterize SARS-CoV-2 transmission and risk factors for COVID-19 among HCW and our larger academic community.
Read the detailed description
This prospective longitudinal cohort study is comprised of: (1) 546 HCW from two RBHS hospitals: Robert Wood Johnson University Hospital (RWJUH) in New Brunswick and University Hospital (UH) in Newark ; (both hospital presidents have approved the study) (2) 283 NHCW from Rutgers faculty, staff, and hospital employees without patient contact. At baseline, investigators will obtain nasopharyngeal or throat swabs, saliva, and blood (for detecting SARS-CoV-2 positivity and immunity, respectively) and collect questionnaire data on sociodemographic factors, lifestyle, and medical history. In the first phase of the study, nasopharyngeal/throat swabs, saliva, and blood collection were collected every two weeks for two months, after which monthly samples were collected for four additional months (9 visits total, including baseline). Weekly questionnaire data and daily temperature data was collected from each participant for the first two months of the study. Investigators will calculate and compare incidence rates and risk factors of SARS-CoV-2 positivity and COVID-19 in healthcare workers and non-healthcare workers and assess symptoms and severity of disease. Through additional funding, we will continue to administer follow-up questionnaires and collect additional specimens (primarily for serology) through 2024.
Our specific aims are:
- To assess the baseline prevalence of SARS-CoV-2 and COVID-19 in the study population.
- To characterize the natural history of SARS-CoV-2 infection in a diverse US workforce, including the incidence of asymptomatic infections and critical illness.
- To determine the incidence of SARS-CoV-2 and COVID-19 in healthcare workers compared with non-healthcare workers.
- To identify the risk factors for acquiring SARS-CoV-2 and developing COVID-19.
- To determine the duration and extent of SARS-CoV-2 shedding.
- To determine immune responses to SARS-CoV-2 infection and or vaccinations.
- Conditions
- Coronavirus, SARS-CoV-2
- Being tested
- Non-Interventional
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
This non-interventional study poses no additional risks to people with pre-existing conditions.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare Workers | 546 HCW with high intensity direct patient care from two RBHS-affiliated academic hospitals: Robert Wood Johnson University Hospital (New Brunswick, NJ) and University Hospital (Newark, NJ) and Rutgers School of Dental Medicine (Newark, NJ). Receives: Other: Non-Interventional | |
| Non-Healthcare Workers | 283 non-healthcare workers (NHCW) from Rutgers faculty, postdoctoral students, students, other trainees, administrators, and staff who do not have patient contact. Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence
Prevalence and 95% confidence intervals, using standard epidemiological methods (Aims 1, 2, and 3).
Measured: up to 24 weeks
Incidence
Incidence and 95% confidence intervals, using standard epidemiological methods (Aims 1, 2, and 3).
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start7 Apr 2020
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 829 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reynold Panettieri, MD, Rutgers, The State University of New Jersey
- Investigators
- Jeffrey L Carson, MD, Principal investigator, Rutgers Biomedical Health SciencesReynold A Panettieri, MD, Principal investigator, Rutgers Institute for Translational Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336215
- Sponsor's protocol ID
- 2020000679
- Status last verified
- May 2026
- First submitted
- 2 Apr 2020
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Colizza V, Barrat A, Barthelemy M, Valleron AJ, Vespignani A. Modeling the worldwide spread of pandemic influenza: baseline case and containment interventions. PLoS Med. 2007 Jan;4(1):e13. doi: 10.1371/journal.pmed.0040013.
PubMed 17253899Bai Y, Yao L, Wei T, Tian F, Jin DY, Chen L, Wang M. Presumed Asymptomatic Carrier Transmission of COVID-19. JAMA. 2020 Apr 14;323(14):1406-1407. doi: 10.1001/jama.2020.2565.
PubMed 32083643Schulert GS, Zhang M, Fall N, Husami A, Kissell D, Hanosh A, Zhang K, Davis K, Jentzen JM, Napolitano L, Siddiqui J, Smith LB, Harms PW, Grom AA, Cron RQ. Whole-Exome Sequencing Reveals Mutations in Genes Linked to Hemophagocytic Lymphohistiocytosis and Macrophage Activation Syndrome in Fatal Cases of H1N1 Influenza. J Infect Dis. 2016 Apr 1;213(7):1180-8. doi: 10.1093/infdis/jiv550. Epub 2015 Nov 23.
PubMed 26597256Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
PubMed 18929686Mahase E. Covid-19: WHO declares pandemic because of "alarming levels" of spread, severity, and inaction. BMJ. 2020 Mar 12;368:m1036. doi: 10.1136/bmj.m1036. No abstract available.
PubMed 32165426Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433. Epub 2020 Feb 26.
PubMed 32113704Han Y, Yang H. The transmission and diagnosis of 2019 novel coronavirus infection disease (COVID-19): A Chinese perspective. J Med Virol. 2020 Jun;92(6):639-644. doi: 10.1002/jmv.25749. Epub 2020 Mar 12.
PubMed 32141619Anderson RM, Heesterbeek H, Klinkenberg D, Hollingsworth TD. How will country-based mitigation measures influence the course of the COVID-19 epidemic? Lancet. 2020 Mar 21;395(10228):931-934. doi: 10.1016/S0140-6736(20)30567-5. Epub 2020 Mar 9. No abstract available.
PubMed 32164834Lai CC, Shih TP, Ko WC, Tang HJ, Hsueh PR. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents. 2020 Mar;55(3):105924. doi: 10.1016/j.ijantimicag.2020.105924. Epub 2020 Feb 17.
PubMed 32081636Fauci AS, Lane HC, Redfield RR. Covid-19 - Navigating the Uncharted. N Engl J Med. 2020 Mar 26;382(13):1268-1269. doi: 10.1056/NEJMe2002387. Epub 2020 Feb 28. No abstract available.
PubMed 32109011Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
PubMed 32091533Pan X, Chen D, Xia Y, Wu X, Li T, Ou X, Zhou L, Liu J. Asymptomatic cases in a family cluster with SARS-CoV-2 infection. Lancet Infect Dis. 2020 Apr;20(4):410-411. doi: 10.1016/S1473-3099(20)30114-6. Epub 2020 Feb 19. No abstract available.
PubMed 32087116Del Rio C, Malani PN. COVID-19-New Insights on a Rapidly Changing Epidemic. JAMA. 2020 Apr 14;323(14):1339-1340. doi: 10.1001/jama.2020.3072. No abstract available.
PubMed 32108857Zhang H, Penninger JM, Li Y, Zhong N, Slutsky AS. Angiotensin-converting enzyme 2 (ACE2) as a SARS-CoV-2 receptor: molecular mechanisms and potential therapeutic target. Intensive Care Med. 2020 Apr;46(4):586-590. doi: 10.1007/s00134-020-05985-9. Epub 2020 Mar 3. No abstract available.
PubMed 32125455Horton DB, Barrett ES, Roy J, Gennaro ML, Andrews T, Greenberg P, Bruiners N, Datta P, Ukey R, Velusamy SK, Fine D, Honnen WJ, Yin YS, Pinter A, Brooks A, Tischfield J, Hussain S, Jagpal S, Swaminathan S, Parmar V, Reilly N, Gaur S, Panettieri RA, Carson JL, Blaser MJ. Determinants and Dynamics of SARS-CoV-2 Infection in a Diverse Population: 6-Month Evaluation of a Prospective Cohort Study. J Infect Dis. 2021 Oct 28;224(8):1345-1356. doi: 10.1093/infdis/jiab411.
PubMed 34387310
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of SARS-CoV-2 Incidence, Transmission, and Disease Severity in Healthcare Workers
- ClinicalTrials.gov ID
- NCT04336215
- Acronym / sponsor ID
- 2020000679
- Conditions
- Coronavirus, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 829 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 7 Apr 2020 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 7 Apr 2020 (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.
Our long-term goal is to protect the health care workforce (HCW) caring for SARS-CoV-2-infected patients, their families, communities, and the general population. Our specific objective is to rapidly establish a prospective cohort to characterize the factors related to viral transmission and disease severity in a large healthcare system. We addressed this hypothesis by recruiting and longitudinally following 546 HCW and a comparison group of 283 non-HCW within a large academic health system, Rutgers Biomedical and Health Sciences (RBHS). By intensively following participants over a several year period (2020-2024) and collecting serial biospecimens (nasopharyngeal/throat swabs, blood, and saliva) and questionnaire data at multiple time points, we will uniquely characterize SARS-CoV-2 transmission and risk factors for COVID-19 among HCW and our larger academic community.
Detailed description
This prospective longitudinal cohort study is comprised of: (1) 546 HCW from two RBHS hospitals: Robert Wood Johnson University Hospital (RWJUH) in New Brunswick and University Hospital (UH) in Newark ; (both hospital presidents have approved the study) (2) 283 NHCW from Rutgers faculty, staff, and hospital employees without patient contact. At baseline, investigators will obtain nasopharyngeal or throat swabs, saliva, and blood (for detecting SARS-CoV-2 positivity and immunity, respectively) and collect questionnaire data on sociodemographic factors, lifestyle, and medical history. In the first phase of the study, nasopharyngeal/throat swabs, saliva, and blood collection were collected every two weeks for two months, after which monthly samples were collected for four additional months (9 visits total, including baseline). Weekly questionnaire data and daily temperature data was collected from each participant for the first two months of the study. Investigators will calculate and compare incidence rates and risk factors of SARS-CoV-2 positivity and COVID-19 in healthcare workers and non-healthcare workers and assess symptoms and severity of disease. Through additional funding, we will continue to administer follow-up questionnaires and collect additional specimens (primarily for serology) through 2024.
Our specific aims are:
- To assess the baseline prevalence of SARS-CoV-2 and COVID-19 in the study population.
- To characterize the natural history of SARS-CoV-2 infection in a diverse US workforce, including the incidence of asymptomatic infections and critical illness.
- To determine the incidence of SARS-CoV-2 and COVID-19 in healthcare workers compared with non-healthcare workers.
- To identify the risk factors for acquiring SARS-CoV-2 and developing COVID-19.
- To determine the duration and extent of SARS-CoV-2 shedding.
- To determine immune responses to SARS-CoV-2 infection and or vaccinations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthcare Workers | – | Other: Non-Interventional546 HCW with high intensity direct patient care from two RBHS-affiliated academic hospitals: Robert Wood Johnson University Hospital (New Brunswick, NJ) and University Hospital (Newark, NJ) and Rutgers School of Dental Medicine (Newark, NJ). |
| Non-Healthcare Workers | – | Other: Non-Interventional283 non-healthcare workers (NHCW) from Rutgers faculty, postdoctoral students, students, other trainees, administrators, and staff who do not have patient contact. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * HCW from two RBHS hospitals: Robert Wood Johnson University Hospital (RWJUH) in New Brunswick and University Hospital (UH) in Newark ; (both hospital presidents have approved the study) * NHCW from Rutgers faculty, staff, and hospital employees without patient contact;
Key inclusion criteria (3 listed)
- 20 years and older
- Hospital and RBHS healthcare workers who have regular direct patient contact (≥3 patients/shift) in emergency rooms or inpatient settings that is expected to continue regularly over the next ≥3 months and who work ≥20 hours in the hospital weekly (residents, clinical fellows, attending physicians, nurse practitioners, physician assistants, registered nurses, license practice nurses, medical technicians, respiratory therapists, physical therapists, clinical pharmacists, dentists, dental hygienists, or dental assistants)
- Hospital workers who do not have patient contact and non-healthcare from the Rutgers faculty, postdoctoral students, administrators, and staff.
Key exclusion criteria (4 listed)
- Previous diagnosis with COVID-19
- Pregnant or have been diagnosed with a new medical condition in the past 30 days or have had a change in medications in the past 30 days
- Participants who have been hospitalized in the past 30 days, had and had an emergency room, urgent care visit, or have had surgery.
- Participants who have a fever on the day of their first visit to the study site (for consent, biospecimen collection, etc.).
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 |
|---|---|---|
| Non-InterventionalThis non-interventional study poses no additional risks to people with pre-existing conditions. | Other | Healthcare Workers, Non-Healthcare Workers |
Primary outcome
Prevalence
Time frame: up to 24 weeks
Prevalence and 95% confidence intervals, using standard epidemiological methods (Aims 1, 2, and 3).
Incidence
Time frame: up to 24 weeks
Incidence and 95% confidence intervals, using standard epidemiological methods (Aims 1, 2, and 3).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 17253899Colizza V, Barrat A, Barthelemy M, Valleron AJ, Vespignani A. Modeling the worldwide spread of pandemic influenza: baseline case and containment interventions. PLoS Med. 2007 Jan;4(1):e13. doi: 10.1371/journal.pmed.0040013.
- Background: PubMed 32083643Bai Y, Yao L, Wei T, Tian F, Jin DY, Chen L, Wang M. Presumed Asymptomatic Carrier Transmission of COVID-19. JAMA. 2020 Apr 14;323(14):1406-1407. doi: 10.1001/jama.2020.2565.
- Background: PubMed 26597256Schulert GS, Zhang M, Fall N, Husami A, Kissell D, Hanosh A, Zhang K, Davis K, Jentzen JM, Napolitano L, Siddiqui J, Smith LB, Harms PW, Grom AA, Cron RQ. Whole-Exome Sequencing Reveals Mutations in Genes Linked to Hemophagocytic Lymphohistiocytosis and Macrophage Activation Syndrome in Fatal Cases of H1N1 Influenza. J Infect Dis. 2016 Apr 1;213(7):1180-8. doi: 10.1093/infdis/jiv550. Epub 2015 Nov 23.
- Background: PubMed 18929686Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
- Background: PubMed 32165426Mahase E. Covid-19: WHO declares pandemic because of "alarming levels" of spread, severity, and inaction. BMJ. 2020 Mar 12;368:m1036. doi: 10.1136/bmj.m1036. No abstract available.
- Background: PubMed 32113704Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433. Epub 2020 Feb 26.
- Background: PubMed 32141619Han Y, Yang H. The transmission and diagnosis of 2019 novel coronavirus infection disease (COVID-19): A Chinese perspective. J Med Virol. 2020 Jun;92(6):639-644. doi: 10.1002/jmv.25749. Epub 2020 Mar 12.
- Background: PubMed 32164834Anderson RM, Heesterbeek H, Klinkenberg D, Hollingsworth TD. How will country-based mitigation measures influence the course of the COVID-19 epidemic? Lancet. 2020 Mar 21;395(10228):931-934. doi: 10.1016/S0140-6736(20)30567-5. Epub 2020 Mar 9. No abstract available.
- Background: PubMed 32081636Lai CC, Shih TP, Ko WC, Tang HJ, Hsueh PR. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents. 2020 Mar;55(3):105924. doi: 10.1016/j.ijantimicag.2020.105924. Epub 2020 Feb 17.
- Background: PubMed 32109011Fauci AS, Lane HC, Redfield RR. Covid-19 - Navigating the Uncharted. N Engl J Med. 2020 Mar 26;382(13):1268-1269. doi: 10.1056/NEJMe2002387. Epub 2020 Feb 28. No abstract available.
- Background: PubMed 32091533Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
- Background: PubMed 32087116Pan X, Chen D, Xia Y, Wu X, Li T, Ou X, Zhou L, Liu J. Asymptomatic cases in a family cluster with SARS-CoV-2 infection. Lancet Infect Dis. 2020 Apr;20(4):410-411. doi: 10.1016/S1473-3099(20)30114-6. Epub 2020 Feb 19. No abstract available.
- 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.
Jeffrey L Carson, MD principal investigator
Rutgers Biomedical Health Sciences
Reynold A Panettieri, MD principal investigator
Rutgers Institute for Translational Medicine and Science
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus and SARS-CoV-2, run by Rutgers, The State University of New Jersey at 7 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 3 inclusion and 4 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 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence (time frame: up to 24 weeks). 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?
On the ClinicalTrials.gov record for NCT04336215, which also lists 15 linked publications.
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 15 May 2026.