A Research Platform to Screen Healthcare Workers- Coordinated Approach to Pandemic Trials of COVID-19
RESPECT
2 other identifiers
observational
7,373
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2020
CompletedFirst Submitted
Initial submission to the registry
September 28, 2020
CompletedFirst Posted
Study publicly available on registry
October 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 3, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 3, 2021
CompletedJuly 10, 2025
July 1, 2025
10 months
September 28, 2020
July 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
2 years
Secondary Outcomes (2)
Prevalence of any COVID-19 variants of concern in asymptomatic workers
2 years
Spread of any COVID-19 variants of concern in asymptomatic workers
2 years
Study Arms (3)
Cohort 1 (A and B)
Cohort 1A included health care workers. Cohort 1B includes individuals that work within a healthcare, research or clinical organization.
Cohort 2
Cohort 2 includes Individuals that work within a food production organization.
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.
Interventions
Nasopharyngeal swab for COVID-19
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.
Provide blood samples to look for COVID-19 specific antibodies and/or proteins at the time of enrollment and after 8 weeks.
Fill out an optional mental health questionnaire.
Provide saliva sample anonymously.
Panbio nasal swab rapid antigen test
Eligibility Criteria
Individuals who work within a food production, healthcare, research or clinical organization.
You may qualify if:
- Individuals who work within a food production, healthcare, research or clinical organization.
- Asymptomatic as per daily screening.
- No contraindication to performing a NP swab.
You may not qualify if:
- 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
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Health Network
Toronto, Ontario, M5G 2N2, Canada
Related Links
Biospecimen
Nasopharyngeal swabs Optional blood samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amit M Oza, MD
University Health Network, Toronto
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2020
First Posted
October 5, 2020
Study Start
April 16, 2020
Primary Completion
February 3, 2021
Study Completion
February 3, 2021
Last Updated
July 10, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share