NCT04438070

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

2 months

First QC Date

June 17, 2020

Last Update Submit

June 17, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • COVID-19 Detection Rate

    8 weeks

Secondary Outcomes (2)

  • Number of outbreaks

    8 weeks

  • Enrollment over time

    8 weeks

Study Arms (4)

Daily active screening only

PLACEBO COMPARATOR
Diagnostic Test: COVID-19 Swab

Daily active screening and self-collected nasal swab

EXPERIMENTAL
Diagnostic Test: COVID-19 Swab

Daily active screening and self-collected oral-nasal swab

EXPERIMENTAL
Diagnostic Test: COVID-19 Swab

Daily active screening and nurse collected nasopharyngeal swab

EXPERIMENTAL
Diagnostic Test: COVID-19 Swab

Interventions

COVID-19 SwabDIAGNOSTIC_TEST

Nasal, Oral-Nasal combined or Nasopharyngeal swab

Daily active screening and nurse collected nasopharyngeal swabDaily active screening and self-collected nasal swabDaily active screening and self-collected oral-nasal swabDaily active screening only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Various Homeless Shelters

Hamilton, Ontario, Canada

RECRUITING

Related Publications (2)

  • Mokashi V, Gilchrist J, Smieja N, Maciejewski J, Marttala S, Beal K, Mbuagbaw L, Bulir D, Smieja M, O'Shea T. Four COVID-19 screening strategies for early case identification within the homeless shelter population: a cluster randomized controlled trial. BMC Infect Dis. 2024 Dec 28;24(1):1478. doi: 10.1186/s12879-024-10148-y.

  • O'Shea T, Mbuagbaw L, Mokashi V, Bulir D, Gilchrist J, Smieja N, Chong S, Marttala S, Vera V, Cvetkovic A, Smieja M. Comparison of four COVID-19 screening strategies to facilitate early case identification within the homeless shelter population: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Nov 23;21(1):941. doi: 10.1186/s13063-020-04890-2.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Timothy O'Shea, MD

CONTACT

Marek Smieja, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Cluster randomized multi-center trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 17, 2020

First Posted

June 18, 2020

Study Start

April 10, 2020

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

June 18, 2020

Record last verified: 2020-06

Locations