Rapid Screening Circuit of COVID 19 in Schools, Pilot Study

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:

1. Speed up the diagnosis and minimize the waiting time between the presentation of symptoms and quarantine of the whole group (if positive)
2. Avoid a waiting time at home with the alteration - often unnecessary - of the day of students, their families, and school staff.
3. Decongest the PCCs, receiving only the cases that need confirmation

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2 (COVID-19)
• Intervention / Treatment: Other: Escola L'Horitzó; Other: Escola John Talabot

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:

1. Speed up the diagnosis and minimize the waiting time between the presentation of symptoms and quarantine of the whole group (if positive)
2. Avoid a waiting time at home with the alteration - often unnecessary - of the day of students, their families, and school staff.
3. Decongest the PCCs, receiving only the cases that need confirmation

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08017
    • John Talabot
  • Barcelona, Spain, 08022
    • Escola l'Horitzó

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; People attending L'Horitzó School (students, teachers, administrative and service staff)	Other: Escola L'Horitzó; 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 .
Other: Control Group; Escola John Talabot, will provide the incidence rate of infections by SARS-CoV-2	Other: Escola John Talabot; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	up to 8 weeks
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	up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 8 weeks

Collaborators and Investigators

• 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
• Investigators: Principal Investigator: Boris Revollo Barriga, PhD, MD, Fundació FLS de Lluita contra la Sida, les Malalties Infeccioses i la Promoció de la Salut i La Ciència

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2021
• Primary Completion (Actual): June 17, 2021
• Study Completion (Actual): June 17, 2021

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Coronavirus; COVID-19; School
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: ESCORAT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No