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

Covid19 Clinical Trial

— RESPECT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04574765
• Other study ID #: OZUHN-001
• Secondary ID: 20-5289
• Status: Active, not recruiting
• Start date: April 16, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Healthcare Worker

Intervention

Diagnostic Test:
• Nasopharyngeal swab
Nasopharyngeal swab for COVID-19

Other:
• Questionnaire collection
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 completion
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
Fill out an optional mental health questionnaire.

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of healthcare workers who are asymptomatic and COVID-19 positive		1 year