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OpenTrials
Completed

NCT Number: NCT04574765

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

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.

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Key information

Conditions

Healthcare Worker COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Health Network

Toronto, Ontario, M5G 2N2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Nasopharyngeal swab

Diagnostic Test

Nasopharyngeal swab for COVID-19

Questionnaire collection (CITF)

Other

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)

Optional blood collection

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Prevalence of any COVID-19 variants of concern in asymptomatic workers

    Time frame: 2 years

    To assess the prevalence of any COVID-19 variants of concern in asymptomatic workers.

  2. Spread of any COVID-19 variants of concern in asymptomatic workers

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

A Research Platform to Screen and Protect Individuals That Work Within a Food Production, Healthcare, Research or Clinical Organization - RESPECT

Acronym: RESPECT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 5, 2020
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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