Healthcare WorkerRESPECTNCT04574765
A Research Platform to Screen Healthcare Workers- Coordinated Approach to Pandemic Trials of COVID-19
An observational study of Healthcare Worker and Covid19, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Recent studies have shown that some individuals may be asymptomatic but continue to shed the COVID-19 virus. These individuals may represent a population that can unknowingly transmit the virus. Healthcare workers (HCW) may acquire COVID-19 from the community or from possibly infected patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthcare Worker, Covid19
- What is being tested?
- Nasopharyngeal swab, Questionnaire collection (CITF) and Optional blood collection
- How many people
- 7,373 participants
- Where
- 1 siteCanada
- Study dates
- 16 Apr 2020to 3 Feb 2021
- 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: Individuals who work within a food production, healthcare, research or clinical organization.
Who may be able to join
- Individuals who work within a food production, healthcare, research or clinical organization.
- Asymptomatic as per daily screening.
- No contraindication to performing a NP swab.
Who cannot join
- Any individual with fever, respiratory or flu-like symptoms will not be eligible. Symptom positive individuals who were not picked up at entry screening will be referred to their Occupational Health. Specific symptoms include:
- Fever, chills or headache
- New or worsening cough
- Shortness of breath, difficulty breathing, sore throat or difficulty swallowing
- Runny nose or stuffy nose without another cause (e.g. allergies)
- Nausea/vomiting, diarrhea, stomach pain
Show all 10Show fewer
- Decrease/loss of taste or smell
- Unexplained fatigue, malaise, muscle aches
- Eye pain or pink eye In addition to those symptoms listed above, individuals should also be screened for symptoms as per their institutional requirements.
- Enrolled in a COVID-related interventional study (eg. Behavioural or drug study).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Research Platform to Screen and Protect Individuals That Work Within a Food Production, Healthcare, Research or Clinical Organization - RESPECT
Recent studies have shown that some individuals may be asymptomatic but continue to shed the COVID-19 virus. These individuals may represent a population that can unknowingly transmit the virus. Healthcare workers (HCW) may acquire COVID-19 from the community or from possibly infected patients. It is important to gather data with respect to this to further understand the prevalence of asymptomatic carriage in individuals who work in research facilities, offices and clinical areas of hospitals and research facilities/institutes since this has important implications for infection control, as well as staff and patient safety. The purpose of this study is to test whether a proportion of these individuals may be asymptomatic shedders of the COVID-19 virus.
Read the detailed description
Healthcare workers of participating institutions who agree to be participants will:
- Fill out some information about participants into a database portal system. Participants will have the ability to check their COVID-19 test results via the portal.
- Have nasopharyngeal (NP) swabs done for COVID-19 testing. This can be done about once a week for up to 8 weeks (about 1-8 swabs total).
- Provide optional blood samples to look for COVID-19 specific antibodies and/or proteins at the time of enrollment and after 8 weeks.
- Fill out questionnaires about participant exposures and travel history, occupation category, any symptoms in the past 21 days, whether they have provided any face-to-face care of a known COVID-19 positive patients in past 14 days or if participants have any children at home who are less than 12 years of age.
- Fill out an optional questionnaire about their mental health
- Be contacted by telephone if participants are tested positive, to determine whether participants have symptoms of COVID-19, and for the results of any follow-up COVID-19 testing that may have been done.
- Conditions
- Healthcare Worker, Covid19
- Being tested
- Nasopharyngeal swab, Questionnaire collection (CITF), Optional blood collection, Optional questionnaire completion (mental health), Optional saliva sample (for validation)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal swabDiagnostic test
Nasopharyngeal swab for COVID-19
Questionnaire collection (CITF)Other
Also called COVID-19 Immunity Task Force (CITF)
Fill out questionnaires regarding exposures and travel history, occupation category, any symptoms in the past 21 days, any face-to-face care of a known COVID-19 positive patients in past 14 days or any children at home who are less than 12 years of age.
Optional blood collectionOther
Provide blood samples to look for COVID-19 specific antibodies and/or proteins at the time of enrollment and after 8 weeks.
Optional questionnaire completion (mental health)Other
Fill out an optional mental health questionnaire.
Optional saliva sample (for validation)Diagnostic test
Provide saliva sample anonymously.
Nasal Swab (rapid antigen test)Diagnostic test
Panbio nasal swab rapid antigen test
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (A and B) | Cohort 1A included health care workers. Cohort 1B includes individuals that work within a healthcare, research or clinical organization. Receives: Diagnostic Test: Nasopharyngeal swab; Other: Questionnaire collection (CITF); Other: Optional blood collection; Other: Optional questionnaire completion (mental health); Diagnostic Test: Optional saliva sample (for validation); Diagnostic Test: Nasal Swab (rapid antigen test) | |
| Cohort 2 | Cohort 2 includes Individuals that work within a food production organization. Receives: Diagnostic Test: Nasopharyngeal swab; Other: Questionnaire collection (CITF); Other: Optional blood collection; Other: Optional questionnaire completion (mental health); Diagnostic Test: Optional saliva sample (for validation) | |
| Cohort 3 | Cohort 3 includes individuals that work within a healthcare, research or clinical organization that will be tested via nasal swab only, with increased frequency of testing. Receives: Diagnostic Test: Nasopharyngeal swab; Other: Optional blood collection; Other: Optional questionnaire completion (mental health); Diagnostic Test: Optional saliva sample (for validation); Diagnostic Test: Nasal Swab (rapid antigen test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of healthcare workers who are asymptomatic while COVID-19 positive
To determine whether asymptomatic individuals who work within a food production, healthcare, research or clinical organizationmay shed CoV during the pandemic. We hypothesize that a small proportion (~1-10%) of these asymptomatic individuals may be CoV+ either because they are in the incubation period prior to symptoms or remain asymptomatic for the duration of infection.
Measured: 2 years
Secondary outcomes (2)
Prevalence of any COVID-19 variants of concern in asymptomatic workers
To assess the prevalence of any COVID-19 variants of concern in asymptomatic workers.
Measured: 2 years
Spread of any COVID-19 variants of concern in asymptomatic workers
To help determine the validity of the Panbio COVID-19 Ag Rapid Test and the saliva sample COVID-19 test by conducting these tests alongside the NP swab test.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start16 Apr 2020
- Primary completion3 Feb 2021
- Study completion3 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthcare WorkerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 7,373 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit M Oza, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574765
- Sponsor's protocol ID
- OZUHN-001
- Other IDs
- 20-5289
- Acronym
- RESPECT
- Status last verified
- Jul 2025
- First submitted
- 28 Sep 2020
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Research Platform to Screen and Protect Individuals That Work Within a Food Production, Healthcare, Research or Clinical Organization - RESPECT
- ClinicalTrials.gov ID
- NCT04574765
- Acronym / sponsor ID
- RESPECT / OZUHN-001
- Conditions
- Healthcare Worker, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,373 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 3 Feb 2021 (actual)
- Study completion
- 3 Feb 2021 (actual)
- First posted
- 5 Oct 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.
Recent studies have shown that some individuals may be asymptomatic but continue to shed the COVID-19 virus. These individuals may represent a population that can unknowingly transmit the virus. Healthcare workers (HCW) may acquire COVID-19 from the community or from possibly infected patients. It is important to gather data with respect to this to further understand the prevalence of asymptomatic carriage in individuals who work in research facilities, offices and clinical areas of hospitals and research facilities/institutes since this has important implications for infection control, as well as staff and patient safety. The purpose of this study is to test whether a proportion of these individuals may be asymptomatic shedders of the COVID-19 virus.
Detailed description
Healthcare workers of participating institutions who agree to be participants will:
- Fill out some information about participants into a database portal system. Participants will have the ability to check their COVID-19 test results via the portal.
- Have nasopharyngeal (NP) swabs done for COVID-19 testing. This can be done about once a week for up to 8 weeks (about 1-8 swabs total).
- Provide optional blood samples to look for COVID-19 specific antibodies and/or proteins at the time of enrollment and after 8 weeks.
- Fill out questionnaires about participant exposures and travel history, occupation category, any symptoms in the past 21 days, whether they have provided any face-to-face care of a known COVID-19 positive patients in past 14 days or if participants have any children at home who are less than 12 years of age.
- Fill out an optional questionnaire about their mental health
- Be contacted by telephone if participants are tested positive, to determine whether participants have symptoms of COVID-19, and for the results of any follow-up COVID-19 testing that may have been done.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (A and B) | – | Diagnostic Test: Nasopharyngeal swab, Other: Questionnaire collection (CITF), Other: Optional blood collection, Other: Optional questionnaire completion (mental health), Diagnostic Test: Optional saliva sample (for validation), Diagnostic Test: Nasal Swab (rapid antigen test)Cohort 1A included health care workers. Cohort 1B includes individuals that work within a healthcare, research or clinical organization. |
| Cohort 2 | – | Diagnostic Test: Nasopharyngeal swab, Other: Questionnaire collection (CITF), Other: Optional blood collection, Other: Optional questionnaire completion (mental health), Diagnostic Test: Optional saliva sample (for validation)Cohort 2 includes Individuals that work within a food production organization. |
| Cohort 3 | – | Diagnostic Test: Nasopharyngeal swab, Other: Optional blood collection, Other: Optional questionnaire completion (mental health), Diagnostic Test: Optional saliva sample (for validation), Diagnostic Test: Nasal Swab (rapid antigen test)Cohort 3 includes individuals that work within a healthcare, research or clinical organization that will be tested via nasal swab only, with increased frequency of testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who work within a food production, healthcare, research or clinical organization.
Key inclusion criteria (3 listed)
- Individuals who work within a food production, healthcare, research or clinical organization.
- Asymptomatic as per daily screening.
- No contraindication to performing a NP swab.
Key exclusion criteria (10 listed)
- Any individual with fever, respiratory or flu-like symptoms will not be eligible. Symptom positive individuals who were not picked up at entry screening will be referred to their Occupational Health. Specific symptoms include:
- Enrolled in a COVID-related interventional study (eg. Behavioural or drug study).
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 |
|---|---|---|
| Nasopharyngeal swabNasopharyngeal swab for COVID-19 | Diagnostic test | Cohort 1 (A and B), Cohort 2, Cohort 3 |
| Questionnaire collection (CITF)Also: COVID-19 Immunity Task Force (CITF)Fill out questionnaires regarding exposures and travel history, occupation category, any symptoms in the past 21 days, any face-to-face care of a known COVID-19 positive patients in past 14 days or any children at home who are less than 12 years of age. | Other | Cohort 1 (A and B), Cohort 2 |
| Optional blood collectionProvide blood samples to look for COVID-19 specific antibodies and/or proteins at the time of enrollment and after 8 weeks. | Other | Cohort 1 (A and B), Cohort 2, Cohort 3 |
| Optional questionnaire completion (mental health)Fill out an optional mental health questionnaire. | Other | Cohort 1 (A and B), Cohort 2, Cohort 3 |
| Optional saliva sample (for validation)Provide saliva sample anonymously. | Diagnostic test | Cohort 1 (A and B), Cohort 2, Cohort 3 |
| Nasal Swab (rapid antigen test)Panbio nasal swab rapid antigen test | Diagnostic test | Cohort 1 (A and B), Cohort 3 |
Primary outcome
Percentage of healthcare workers who are asymptomatic while COVID-19 positive
Time frame: 2 years
To determine whether asymptomatic individuals who work within a food production, healthcare, research or clinical organizationmay shed CoV during the pandemic. We hypothesize that a small proportion (~1-10%) of these asymptomatic individuals may be CoV+ either because they are in the incubation period prior to symptoms or remain asymptomatic for the duration of infection.
2 secondary outcomes
Prevalence of any COVID-19 variants of concern in asymptomatic workers
Time frame: 2 years
Spread of any COVID-19 variants of concern in asymptomatic workers
Time frame: 2 years
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 10 Jul 2025.
- RESEARCH ARTICLELink provided by the sponsor.
- 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.
Amit M Oza, MD principal investigator
University Health Network, Toronto
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 Healthcare Worker and Covid19, run by University Health Network, Toronto at 1 site in Canada.
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 10 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 10 Jul 2025. 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 Canada. 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?
Percentage of healthcare workers who are asymptomatic while COVID-19 positive (time frame: 2 years). 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 10 Jul 2025.