Recruiting

Observational Study

Sponsor:

St. Joseph's Healthcare Hamilton

Code:

NCT04438070

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

COVID-19 Swab

Study Details

Brief summary:

Residents in homeless shelters will be randomized to 4 different COVID-19 screening strategies with the primary outcome being COVID-19 detection rate.

Conditions

COVID-19

Study ID

NCT04438070

Start date

Apr 10, 2020

Status verified date

Jun, 2020

Completion date

Jun, 2020

Anticipated

Primary completion date

Jun, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age greater than or equal to 18
  • Able to provide oral consent
  • Able to perform a self-collected swab if in the relevant intervention arm

Exclusion Criteria:

-

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

placebo comparator: Daily active screening only

experimental: Daily active screening and self-collected nasal swab

experimental: Daily active screening and self-collected oral-nasal swab

experimental: Daily active screening and nurse collected nasopharyngeal swab

Interventions

COVID-19 Swab

Nasal, Oral-Nasal combined or Nasopharyngeal swab

Primary outcome measure

  • COVID-19 Detection Rate [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Timothy O'Shea, MD

905-521-2100osheat@mcmaster.ca

Marek Smieja, MD, PhD

905-521-6021msmieja@stjosham.on.ca

Locations

Various Homeless Shelters

Recruiting

Hamilton, Ontario, Canada

Contacts

Timothy O'Shea, MD

905-521-2100osheat@mcmaster.ca

Principal Investigator:

Timothy O'Shea, MD

More Information

Sponsor

St. Joseph's Healthcare Hamilton

Last update posted

Jun 18, 2020

Last verified

Jun, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton on 2020-06-18.