A Research Platform to Screen Healthcare Workers- Coordinated Approach to Pandemic Trials of COVID-19 (RESPECT)

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Healthcare Worker
• Intervention / Treatment: 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)

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 Type: Observational
• Enrollment (Actual): 7373

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2N2
      • University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Individuals who work within a food production, healthcare, research or clinical organization.

Description

Inclusion Criteria:

• Individuals who work within a food production, healthcare, research or clinical organization.
• Asymptomatic as per daily screening.
• No contraindication to performing a NP swab.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1 (A and B); Cohort 1A included health care workers. Cohort 1B includes individuals that work within a healthcare, research or clinical organization.	Diagnostic test: Nasopharyngeal swab; Nasopharyngeal swab for COVID-19; Other: Questionnaire collection (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 Names: COVID-19 Immunity Task Force (CITF); Other: Optional blood collection; Provide blood samples to look for COVID-19 specific antibodies and/or proteins at the time of enrollment and after 8 weeks.; Other: Optional questionnaire completion (mental health); Fill out an optional mental health questionnaire.; Diagnostic test: Optional saliva sample (for validation); Provide saliva sample anonymously.; Diagnostic test: Nasal Swab (rapid antigen test); Panbio nasal swab rapid antigen test
Cohort 2; Cohort 2 includes Individuals that work within a food production organization.	Diagnostic test: Nasopharyngeal swab; Nasopharyngeal swab for COVID-19; Other: Questionnaire collection (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 Names: COVID-19 Immunity Task Force (CITF); Other: Optional blood collection; Provide blood samples to look for COVID-19 specific antibodies and/or proteins at the time of enrollment and after 8 weeks.; Other: Optional questionnaire completion (mental health); Fill out an optional mental health questionnaire.; Diagnostic test: Optional saliva sample (for validation); Provide saliva sample anonymously.
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.	Diagnostic test: Nasopharyngeal swab; Nasopharyngeal swab for COVID-19; Other: Optional blood collection; Provide blood samples to look for COVID-19 specific antibodies and/or proteins at the time of enrollment and after 8 weeks.; Other: Optional questionnaire completion (mental health); Fill out an optional mental health questionnaire.; Diagnostic test: Optional saliva sample (for validation); Provide saliva sample anonymously.; Diagnostic test: Nasal Swab (rapid antigen test); Panbio nasal swab rapid antigen test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	2 years

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Amit M Oza, MD, University Health Network, Toronto

Publications and helpful links

Helpful Links

• RESEARCH ARTICLE

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2020
• Primary Completion (Actual): February 3, 2021
• Study Completion (Actual): February 3, 2021

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: OZUHN-001; 20-5289 (Other Identifier: University Health Network)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No