Occupational Exposure to SARS-CoV-2CHAMPSNCT04370821
COVID-19 CHAMPS Study of Healthcare, First Responder and Service Workers
An observational study of Occupational Exposure to SARS-CoV-2 and COVID-19, run by Villanova University at 1 site in United States.
Trial summary
The COVID-19 CHAMPS Study will obtain data on the physical and mental health and well-being of workers potentially exposed to the SARS-CoV-2 virus in the course of their duties. Included are a broad range of occupations including those working in the community (police officers, firefighters, emergency personnel… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occupational Exposure to SARS-CoV-2, COVID-19
- How many people
- 2,600 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2020to 1 Jan 2025
- How long will I take part?
- 4 Years
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any adult exposed to increased risk of infection by SARS-CoV-2 as a result of work in the community or in settings where COVID-19 patients are screened, diagnosed or receive care. Included are first responders (e.g., police officers, firefighters, emergency medical technicians, paramedics) service employees (office staff, maintenance, housekeeping, food service), and healthcare professionals (e.g., physicians, nurses, phlebotomists, respiratory therapists, pharmacists).
Who may be able to join
- Age 18 years or older
- Working in a facility that screens, diagnoses, or treats COVID-19 patients or in the community as a first responder.
- Able to read and speak English
Who cannot join
- Anyone not meeting Inclusion Criteria.
Trial locations and contacts
1 site in 1 country.
About this study
The COVID-19 CHAMPS Study will obtain data on the physical and mental health and well-being of workers potentially exposed to the SARS-CoV-2 virus in the course of their duties. Included are a broad range of occupations including those working in the community (police officers, firefighters, emergency personnel, screening staff) as well as in permanent or temporary sites that care for patients (service staff, nurses, physicians and other health professionals). CHAMPS will obtain data on various exposure factors and health and create a registry of participants for extended follow up and sub-studies.
Read the detailed description
The objective of the US COVID-19 CHAMPS Study is to assess the short- and long-term physical, social and behavioral health of all who were involved in supporting or delivering care for COVID-19 patients. Included are first responders, maintenance and support staff as well as healthcare professionals of all specialties and services. Initially the study will obtain data on the working environment and emotional and physical health. Additional data will be obtained on self-management, response strategies, effects on family, social and personal life and careers. This well-characterized cohort of workers will enable characterization of the health and social effects of their service, and prospective research on their future physical and mental health. It will also serve as a registry for future, hypothesis-driven sub-studies of behavioral and biological coping mechanisms and allostatic load, as well as randomized clinical trials. Participants will be recruited throughout the United States and its territories (Puerto Rico, Guam, the US Virgin Islands) with outcomes followed longitudinally for twenty years.
Initial analysis will be descriptive and include computation of frequency distributions, adjusted odds ratios and 95% confidence intervals. Multiple logistic regression methods will be used to assess association of health symptoms or conditions with estimates of exposure to COVID-19. Psychological distress will be estimated from self-reported responses to validated psychological instruments and survey items created to capture the unique aspects of exposure to COVID-19 in workplace settings. Odds rations will be adjusted for sex, age, race/ethnicity and job classification. The logistic regression model(s) will include self-reported baseline health status and other variables. Preliminary explorations of variable associations will be performed to aid with the development of sub-studies from the registry.
No direct health benefits are anticipated for participating in the study, but participants may learn about their health. Participation in the study provides the participants the opportunity to express the impact of responding to the COVID-19 pandemic on their health, which may be a source of relief. Participants may feel satisfaction about sharing information about their experiences that may help healthcare systems to plan for future health-related emergencies.
- Conditions
- Occupational Exposure to SARS-CoV-2, COVID-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Sample Size of enrolled CHAMPS Study participants by demographic characteristics during the first two years of the study
Measured: Two years
Exposure to SARS-CoV-2 based on models computed from participant baseline data and community variables, if available.
Measured: Two years
Infectious disease and chronic disease incidence rates by demographic characteristics
Measured: Four years
Completeness of data by demographic characteristics.
Measured: Two years
Secondary outcomes (2)
Participation rates in ancillary and sub-studies within the CHAMPS registry.
Measured: four years
Number of participants enrolled in randomized trials based on the CHAMPS registry
Measured: four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start9 May 2020
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Occupational Exposure to SARS-CoV-2Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,600 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Villanova University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Brom, PhD, Principal investigator, Villanova UniversityDonna Havens, PhD,RN,FAAN, Principal investigator, Villanova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370821
- Sponsor's protocol ID
- IRB FY2020-215
- Acronym
- CHAMPS
- Status last verified
- Aug 2024
- First submitted
- 27 Apr 2020
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaufmann PG, Havens DS, Mensinger JL, Bradley PK, Brom HM, Copel LC, Costello A, D'Annunzio C, Dean Durning J, Maldonado L, Barrow McKenzie A, Smeltzer SC, Yost J; CHAMPS Study Investigators. The COVID-19 Study of Healthcare and Support Personnel (CHAMPS): Protocol for a Longitudinal Observational Study. JMIR Res Protoc. 2021 Oct 7;10(10):e30757. doi: 10.2196/30757.
PubMed 34582354
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 CHAMPS Study of Healthcare, First Responder and Service Workers
- ClinicalTrials.gov ID
- NCT04370821
- Acronym / sponsor ID
- CHAMPS / IRB FY2020-215
- Conditions
- Occupational Exposure to SARS-CoV-2, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,600 participants (estimated)
- Lead sponsor
- Villanova UniversityUniversity, hospital or other
- Study start
- 9 May 2020 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 1 May 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.
The COVID-19 CHAMPS Study will obtain data on the physical and mental health and well-being of workers potentially exposed to the SARS-CoV-2 virus in the course of their duties. Included are a broad range of occupations including those working in the community (police officers, firefighters, emergency personnel, screening staff) as well as in permanent or temporary sites that care for patients (service staff, nurses, physicians and other health professionals). CHAMPS will obtain data on various exposure factors and health and create a registry of participants for extended follow up and sub-studies.
Detailed description
The objective of the US COVID-19 CHAMPS Study is to assess the short- and long-term physical, social and behavioral health of all who were involved in supporting or delivering care for COVID-19 patients. Included are first responders, maintenance and support staff as well as healthcare professionals of all specialties and services. Initially the study will obtain data on the working environment and emotional and physical health. Additional data will be obtained on self-management, response strategies, effects on family, social and personal life and careers. This well-characterized cohort of workers will enable characterization of the health and social effects of their service, and prospective research on their future physical and mental health. It will also serve as a registry for future, hypothesis-driven sub-studies of behavioral and biological coping mechanisms and allostatic load, as well as randomized clinical trials. Participants will be recruited throughout the United States and its territories (Puerto Rico, Guam, the US Virgin Islands) with outcomes followed longitudinally for twenty years.
Initial analysis will be descriptive and include computation of frequency distributions, adjusted odds ratios and 95% confidence intervals. Multiple logistic regression methods will be used to assess association of health symptoms or conditions with estimates of exposure to COVID-19. Psychological distress will be estimated from self-reported responses to validated psychological instruments and survey items created to capture the unique aspects of exposure to COVID-19 in workplace settings. Odds rations will be adjusted for sex, age, race/ethnicity and job classification. The logistic regression model(s) will include self-reported baseline health status and other variables. Preliminary explorations of variable associations will be performed to aid with the development of sub-studies from the registry.
No direct health benefits are anticipated for participating in the study, but participants may learn about their health. Participation in the study provides the participants the opportunity to express the impact of responding to the COVID-19 pandemic on their health, which may be a source of relief. Participants may feel satisfaction about sharing information about their experiences that may help healthcare systems to plan for future health-related emergencies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any adult exposed to increased risk of infection by SARS-CoV-2 as a result of work in the community or in settings where COVID-19 patients are screened, diagnosed or receive care. Included are first responders (e.g., police officers, firefighters, emergency medical technicians, paramedics) service employees (office staff, maintenance, housekeeping, food service), and healthcare professionals (e.g., physicians, nurses, phlebotomists, respiratory therapists, pharmacists).
Key inclusion criteria (3 listed)
- Age 18 years or older
- Working in a facility that screens, diagnoses, or treats COVID-19 patients or in the community as a first responder.
- Able to read and speak English
Key exclusion criteria (1 listed)
- Anyone not meeting Inclusion Criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sample Size of enrolled CHAMPS Study participants by demographic characteristics during the first two years of the study
Time frame: Two years
Exposure to SARS-CoV-2 based on models computed from participant baseline data and community variables, if available.
Time frame: Two years
Infectious disease and chronic disease incidence rates by demographic characteristics
Time frame: Four years
Completeness of data by demographic characteristics.
Time frame: Two years
2 secondary outcomes
Participation rates in ancillary and sub-studies within the CHAMPS registry.
Time frame: four years
Number of participants enrolled in randomized trials based on the CHAMPS registry
Time frame: four years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Derived from this study: PubMed 34582354Kaufmann PG, Havens DS, Mensinger JL, Bradley PK, Brom HM, Copel LC, Costello A, D'Annunzio C, Dean Durning J, Maldonado L, Barrow McKenzie A, Smeltzer SC, Yost J; CHAMPS Study Investigators. The COVID-19 Study of Healthcare and Support Personnel (CHAMPS): Protocol for a Longitudinal Observational Study. JMIR Res Protoc. 2021 Oct 7;10(10):e30757. doi: 10.2196/30757.
- Individual participant dataSharing planned: No
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.
Heather Brom, PhD principal investigator
Villanova University
Donna Havens, PhD,RN,FAAN principal investigator
Villanova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occupational Exposure to SARS-CoV-2 and COVID-19, run by Villanova University at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Sample Size of enrolled CHAMPS Study participants by demographic characteristics during the first two years of the study (time frame: Two years). The study lists 4 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 NCT04370821, which also lists 1 linked publication.
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 19 Aug 2024.