SARS-CoV-2 (COVID-19)NCT04878809
Rapid Screening Circuit of COVID 19 in Schools, Pilot Study
A study testing Escola L'Horitzó and Escola John Talabot in people with SARS-CoV-2 (COVID-19), run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 (COVID-19)
- What is being tested?
- Escola L'Horitzó and Escola John Talabot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 2 sitesSpain
- Study dates
- 22 Apr 2021to 17 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Not applicable
Trial locations and contacts
2 sites in 1 country.
About this 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
Read more
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
Read the 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
- Conditions
- SARS-CoV-2 (COVID-19)
- Being tested
- Escola L'Horitzó, Escola John Talabot
- Keywords
- SARS-CoV-2, COVID-19, Coronavirus, School
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Escola L'HoritzóOther
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 .
Escola John TalabotOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | People attending L'Horitzó School (students, teachers, administrative and service staff) Receives: Other: Escola L'Horitzó |
| Control Group | Other | Escola John Talabot, will provide the incidence rate of infections by SARS-CoV-2 Receives: Other: Escola John Talabot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: up to 8 weeks
Secondary outcomes (1)
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.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start22 Apr 2021
- Primary completion17 Jun 2021
- Study completion17 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 (COVID-19)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Sponsor type
- University, hospital or other
- Collaborators
- Escola L'Horitzó, Escola John Talabot
- Responsible party
- Sponsor
- Investigators
- Boris Revollo Barriga, PhD, MD, Principal investigator, Fundació FLS de Lluita contra la Sida, les Malalties Infeccioses i la Promoció de la Salut i La Ciència
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878809
- Sponsor's protocol ID
- ESCORAT
- Status last verified
- Jun 2021
- First submitted
- 28 Apr 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Constantin AM, Noertjojo K, Sommer I, Pizarro AB, Persad E, Durao S, Nussbaumer-Streit B, McElvenny DM, Rhodes S, Martin C, Sampson O, Jorgensen KJ, Bruschettini M. Workplace interventions to reduce the risk of SARS-CoV-2 infection outside of healthcare settings. Cochrane Database Syst Rev. 2024 Apr 10;4(4):CD015112. doi: 10.1002/14651858.CD015112.pub3.
PubMed 38597249Pizarro 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.
PubMed 35514111
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Screening Circuit of COVID 19 in Schools, Pilot Study
- ClinicalTrials.gov ID
- NCT04878809
- Acronym / sponsor ID
- ESCORAT
- Conditions
- SARS-CoV-2 (COVID-19)
- Keywords
- SARS-CoV-2, COVID-19, Coronavirus, School
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaUniversity, hospital or other
- Collaborators
- Escola L'Horitzó, Escola John Talabot
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 17 Jun 2021 (actual)
- Study completion
- 17 Jun 2021 (actual)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental Group: People attending L'Horitzó School (students, teachers, administrative and service staff) Control Group (No Intervention): Escola John Talabot
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Escola L'HoritzóPeople attending L'Horitzó School (students, teachers, administrative and service staff) |
| Control Group | Other | Other: Escola John TalabotEscola John Talabot, will provide the incidence rate of infections by SARS-CoV-2 |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Escola L'HoritzóDiagnosis 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 | Experimental group |
| Escola John TalabotJohn Talabot School will provide the incidence of infection by SARS-CoV-2 in order to compare the incidence of infection from L'Horitzó School. | Other | Control Group |
Primary outcome
Incidence rate of people infected with SARS-CoV-2
Time frame: up to 8 weeks
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
Time frame: up to 8 weeks
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
1 secondary outcome
Incidence rate of people infected with SARS-CoV-2
Time frame: up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Derived from this study: PubMed 38597249Constantin AM, Noertjojo K, Sommer I, Pizarro AB, Persad E, Durao S, Nussbaumer-Streit B, McElvenny DM, Rhodes S, Martin C, Sampson O, Jorgensen KJ, Bruschettini M. Workplace interventions to reduce the risk of SARS-CoV-2 infection outside of healthcare settings. Cochrane Database Syst Rev. 2024 Apr 10;4(4):CD015112. doi: 10.1002/14651858.CD015112.pub3.
- Derived from this study: PubMed 35514111Pizarro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris Revollo Barriga, PhD, MD principal investigator
Fundació FLS de Lluita contra la Sida, les Malalties Infeccioses i la Promoció de la Salut i La Ciència
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Escola L'Horitzó and Escola John Talabot in people with SARS-CoV-2 (COVID-19), run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of people infected with SARS-CoV-2 (time frame: up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04878809, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.