NCT04531254

Back to School COVID-19 Simulation Study

Completed NA Last updated 30 November 2022

What this trial tests

NA trial testing Wearing a face mask at all times in Covid19 in 174 participants. Completed in 31 August 2020.

Timeline

10 August 2020

Primary endpoint
31 August 2020

31 August 2020

Quick facts

Lead sponsor	The Hospital for Sick Children
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	174
Start date	10 August 2020
Primary completion	31 August 2020
Estimated completion	31 August 2020
Sites	1 location across Canada

Drugs / interventions tested

• Wearing a face mask at all times

Conditions studied

• Covid19 — all drugs for Covid19 →
• Schools — all drugs for Schools →

Sponsor

The Hospital for Sick Children

Who can join

Adults 4 to 18, any sex, with Covid19 or Schools. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This will be a prospective study simulating return to school for two full days prior to the start of the school year in September. Volunteer students and teachers from six grade ranges will be recruited to participate in the study. In each grade range, there will be two classes that will participate, one that will be assigned to wear face masks/coverings at all times (experimental group/class) and the other that will not wear face masks/coverings at all times (control group/class). Students will be randomized to either the masking at all times (experimental across all grades) or no masking (control across JK-Grade 4) / masking only when physical distance can be maintained (control across Grade 5-Grade 12) class in their appropriate grade. Personal behaviours and person-to-person interactions will be recorded using video cameras. In addition, a safe biological indicator will be applied to the hands to simulate potential asymptomatic infection in a subset of students. Other students will have sanitizer applied so that students are blinded to who has the indicator. Cameras will be used to document how the indicator moves throughout the classroom.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Return to school and mask-wearing in class during the COVID-19 pandemic: Student perspectives from a school simulation study.
   Coelho SG, Segovia A, Anthony SJ, Lin J, et al · · 2022 · cited 8× · PMID 35620563 · DOI 10.1093/pch/pxab102
2. Impact of COVID-19 Public Health Protocols on Teachers Instructing Children and Adolescents During an In-Person Simulation.
   Lin J, Pol SJ, Korczak DJ, Coelho S, et al · · 2022 · cited 7× · PMID 35614958
3. Effect of Wearing a Face Mask on Hand-to-Face Contact by Children in a Simulated School Environment: The Back-to-School COVID-19 Simulation Randomized Clinical Trial.
   Science M, Caldeira-Kulbakas M, Parekh RS, Maguire BR, et al · · 2022 · cited 2× · PMID 36279142 · DOI 10.1001/jamapediatrics.2022.3833
4. Le retour en classe et le port du masque pendant la pandémie de COVID-19 : le point de vue des élèves d’après une étude de simulation scolaire.
   Coelho SG, Segovia A, Anthony SJ, Lin J, et al · · 2022 · PMID 36092299 · DOI 10.1093/pch/pxac017