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Rapid Screening Circuit of COVID 19 in Schools, Pilot Study

Primary Purpose

SARS-CoV-2 (COVID-19)

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Escola L'Horitzó
Escola John Talabot
Sponsored by
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for SARS-CoV-2 (COVID-19) focused on measuring SARS-CoV-2, COVID-19, Coronavirus, School

Eligibility Criteria

6 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Students older than 6 years, teachers, administrative and service staff who attend regularly to L'Horitzó school.
  • All participants will be required to sign an informed consent form performing a nasal and nasopharyngeal swab for performing a rapid detection test of antigens (In students under the age of 12, informed consent will be signed by their parent or legal tutor, in students equal to or older than 12 years, but under 18 consent it will be signed both by the student and by his / her parent or legal guardian. The participant over the age of 18 will sign the document in person, unless it is incapacitated, in which case you must sign your legal representative).

Exclusion Criteria:

• Not applicable

Sites / Locations

  • John Talabot
  • Escola l'Horitzó

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental group

Control Group

Arm Description

People attending L'Horitzó School (students, teachers, administrative and service staff)

Escola John Talabot, will provide the incidence rate of infections by SARS-CoV-2

Outcomes

Primary Outcome Measures

Incidence rate of people infected with SARS-CoV-2
Incidence rate of asymptomatic people infected with SARS-CoV-2, detected by rapid antigen detection tests in nasal swabs (self -taken)
Incidence rate of people infected with SARS-CoV-2
Incidence rate of symptomatic/asymptomatic people infected with SARS-CoV-2, detected by rapid antigen detection tests in nasopharyngeal swabs performed by trained teachers from the school L'Horitzó

Secondary Outcome Measures

Incidence rate of people infected with SARS-CoV-2
Incidence rate of symptomatic people infected with SARS-CoV-2, detected by PCR nasopharyngeal performed under clinical practice.

Full Information

First Posted
April 28, 2021
Last Updated
June 17, 2021
Sponsor
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Collaborators
Escola L'Horitzó, Escola John Talabot
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1. Study Identification

Unique Protocol Identification Number
NCT04878809
Brief Title
Rapid Screening Circuit of COVID 19 in Schools, Pilot Study
Official Title
Rapid Screening Circuit of COVID 19 in Schools, Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 22, 2021 (Actual)
Primary Completion Date
June 17, 2021 (Actual)
Study Completion Date
June 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Collaborators
Escola L'Horitzó, Escola John Talabot

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The outbreak of coronavirus disease 2019 (COVID-19), caused by acute respiratory syndrome severe coronavirus 2 (SARS-CoV-2), emerged in Wuhan in December 2019 and has spread which poses a serious threat to public health. While 80% of the patients are asymptomatic or have a mild illness, 20% develop a serious illness. Predominant symptoms include fever, cough, and myalgias. Most children have one mild or asymptomatic disease that can be resolved without medical attention and that, exceptionally, may progress to pneumonia and respiratory failure requiring hospitalization Schools have started the course with strict protocols to prevent the transmission of SARS-Cov-2 among the members of the educational communities and thus avoid an uncontrollability of the epidemic. These protocols include scaled entrances in the centers and differentiated circulation to optimize compliance with social distance. They also include the creation of coexistence groups, the Ventilation of the spaces, hand washing, disinfection of furniture, and wearing a face mask. One key point in the prevention of infection is the rapid detection of infected individuals, their isolation immediate and quarantine, and screening of coexistence groups of positive cases. The diagnosis of Suspicious cases from both schools and other settings is done with a PCR, mostly in Primary Care Centers (PCC). This is causing an increased considerable volume of work for primary care centers. In addition to the overload of the PCCs, the waiting time between sampling and PCR means that the person must remain at home until the result is obtained, with the negative impact that this means on the daily lives of students, teachers, and families. The use of a quick test performed on the own schools and with staff from the center itself trained to do this first screening would have three very relevant consequences for the system: Speed up the diagnosis and minimize the waiting time between the presentation of symptoms and quarantine of the whole group (if positive) Avoid a waiting time at home with the alteration - often unnecessary - of the day of students, their families, and school staff. Decongest the PCCs, receiving only the cases that need confirmation
Detailed Description
The outbreak of coronavirus disease 2019 (COVID-19), caused by acute respiratory syndrome severe coronavirus 2 (SARS-CoV-2), emerged in Wuhan in December 2019 and has spread which poses a serious threat to public health. While 80% of the patients are asymptomatic or have a mild illness, 20% develop a serious illness. Predominant symptoms include fever, cough, and myalgias. Most children have one mild or asymptomatic disease that can be resolved without medical attention and that, exceptionally, may progress to pneumonia and respiratory failure requiring hospitalization Schools have started the course with strict protocols to prevent the transmission of SARS-Cov-2 among the members of the educational communities and thus avoid an uncontrollability of the epidemic. These protocols include scaled entrances in the centers and differentiated circulation to optimize compliance with social distance. They also include the creation of coexistence groups, the Ventilation of the spaces, hand washing, disinfection of furniture, and wearing a face mask. One key point in the prevention of infection is the rapid detection of infected individuals, their isolation immediate and quarantine, and screening of coexistence groups of positive cases. The diagnosis of Suspicious cases from both schools and other settings is done with a PCR, mostly in Primary Care Centers (PCC). This is causing an increased considerable volume of work for primary care centers. In addition to the overload of the PCCs, the waiting time between sampling and PCR means that the person must remain at home until the result is obtained, with the negative impact that this means on the daily lives of students, teachers, and families. The use of a quick test performed on the own schools and with staff from the center itself trained to do this first screening would have three very relevant consequences for the system: Speed up the diagnosis and minimize the waiting time between the presentation of symptoms and quarantine of the whole group (if positive) Avoid a waiting time at home with the alteration - often unnecessary - of the day of students, their families, and school staff. Decongest the PCCs, receiving only the cases that need confirmation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 (COVID-19)
Keywords
SARS-CoV-2, COVID-19, Coronavirus, School

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental Group: People attending L'Horitzó School (students, teachers, administrative and service staff) Control Group (No Intervention): Escola John Talabot
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
People attending L'Horitzó School (students, teachers, administrative and service staff)
Arm Title
Control Group
Arm Type
Other
Arm Description
Escola John Talabot, will provide the incidence rate of infections by SARS-CoV-2
Intervention Type
Other
Intervention Name(s)
Escola L'Horitzó
Intervention Description
Diagnosis of SARS-CoV-2 infection by rapid antigen detection tests in nasal and nasopharyngeal swabs, in asymptomatic and symptomatic subjects who attend regularly to L'Horitzó school .
Intervention Type
Other
Intervention Name(s)
Escola John Talabot
Intervention Description
John Talabot School will provide the incidence of infection by SARS-CoV-2 in order to compare the incidence of infection from L'Horitzó School.
Primary Outcome Measure Information:
Title
Incidence rate of people infected with SARS-CoV-2
Description
Incidence rate of asymptomatic people infected with SARS-CoV-2, detected by rapid antigen detection tests in nasal swabs (self -taken)
Time Frame
up to 8 weeks
Title
Incidence rate of people infected with SARS-CoV-2
Description
Incidence rate of symptomatic/asymptomatic people infected with SARS-CoV-2, detected by rapid antigen detection tests in nasopharyngeal swabs performed by trained teachers from the school L'Horitzó
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Incidence rate of people infected with SARS-CoV-2
Description
Incidence rate of symptomatic people infected with SARS-CoV-2, detected by PCR nasopharyngeal performed under clinical practice.
Time Frame
up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Students older than 6 years, teachers, administrative and service staff who attend regularly to L'Horitzó school. All participants will be required to sign an informed consent form performing a nasal and nasopharyngeal swab for performing a rapid detection test of antigens (In students under the age of 12, informed consent will be signed by their parent or legal tutor, in students equal to or older than 12 years, but under 18 consent it will be signed both by the student and by his / her parent or legal guardian. The participant over the age of 18 will sign the document in person, unless it is incapacitated, in which case you must sign your legal representative). Exclusion Criteria: • Not applicable
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris Revollo Barriga, PhD, MD
Organizational Affiliation
Fundació FLS de Lluita contra la Sida, les Malalties Infeccioses i la Promoció de la Salut i La Ciència
Official's Role
Principal Investigator
Facility Information:
Facility Name
John Talabot
City
Barcelona
ZIP/Postal Code
08017
Country
Spain
Facility Name
Escola l'Horitzó
City
Barcelona
ZIP/Postal Code
08022
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
35514111
Citation
Pizarro AB, Persad E, Durao S, Nussbaumer-Streit B, Engela-Volker JS, McElvenny D, Rhodes S, Stocking K, Fletcher T, Martin C, Noertjojo K, Sampson O, Verbeek JH, Jorgensen KJ, Bruschettini M. Workplace interventions to reduce the risk of SARS-CoV-2 infection outside of healthcare settings. Cochrane Database Syst Rev. 2022 May 6;5(5):CD015112. doi: 10.1002/14651858.CD015112.pub2.
Results Reference
derived

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Rapid Screening Circuit of COVID 19 in Schools, Pilot Study

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