Clinical trial NCT04574765: A Research Platform to Screen Healthcare Workers- Coordinated Approach to Pandemic Trials of COVID-19
Official title: A Research Platform to Screen and Protect Individuals That Work Within a Food Production, Healthcare, Research or Clinical Organization - RESPECT
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Healthcare Worker
Covid19
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who work within a food production, healthcare, research or clinical organization.

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of healthcare workers who are asymptomatic and COVID-19 positive
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Amit M Oza, MD
role: PRINCIPAL_INVESTIGATOR
References: