Reducing Respiratory Virus Transmission in Bangladeshi Classrooms

SARS-CoV2 Infection Clinical Trial

Official title:

Reducing Respiratory Virus Transmission in Bangladeshi Classrooms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06247059
• Other study ID #: 73657
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2024
• Est. completion date: March 2026

Study information

• Verified date: January 2024
• Source: Stanford University
• Contact: Mahbubur Rahman
• Phone: +88 02 2222 77 001-10
• Email: Mahbubr[@]icddrb.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will test if affordable air cleaning devices (box fans with a filter attached and/or ultraviolet light lamps) installed in classrooms can reduce the number of viral respiratory illnesses schoolchildren experience.

Description:

This cluster-randomized controlled trial in Bangladesh schools will examine whether low-cost air filtration and/or human-safe ultraviolet germicidal light interventions can reduce the incidence of schoolchildren's respiratory viral infections. The main study objectives are:

1. Pilot and optimize an intervention to filter classroom air.

2. Pilot and optimize an intervention to treat classroom air with ultraviolet light.

3. Assess the separate and combined effect of air filtration and ultraviolet light on the incidence of polymerase chain reaction (PCR) confirmed illness from respiratory viruses.

Methods: The study will take place in 60 government primary schools in Dhaka, Bangladesh. Within each enrolled school, 5 classrooms of students in grades 3, 4 and 5 will be randomly assigned to receive:

1. Box fans with a filter attachment.

2. 220 nanometer (nm) wavelength ultraviolet light air cleaner lamps.

3. Both the box fans with a filter and the 220 nm ultraviolet lamps.

4. No device: a control group that receives no additional device ("standard of care"). Two classrooms within each school will be assigned as controls.

Why does this matter?: Clarifying the impact of low-cost practical solutions could support the adoption of these strategies that could reduce influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission in schools in order to reduce the burden of respiratory illness in these communities.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20000
• Est. completion date: March 2026
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

Inclusion Criteria:

• Schoolchildren of Bangladesh Government-run primary schools in Dhaka, Bangladesh ages 9 - 12 years, of all gender identifiers (male, female, transgender, prefer not to designate), without specific ethnic selection amongst standard school children of Bangladesh government schools in Dhaka, Bangladesh.

Exclusion Criteria:

• School children of non-Bangladesh Government-run primary schools and/or schoolchildren who do not attend a Bangladesh Government-run primary school in Dhaka, Bangladesh.

• School children who are not able to or have a contraindication with the ability to comply with study procedures.

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• Influenza Viral Infections
• Respiratory Viral Infection
• SARS-CoV2 Infection
• Virus Diseases

Intervention

Device:
• Box Fan
Classrooms assigned to this arm will be equipped with 2 - 8 box fans each with a single minimum efficiency reporting value-14 (MERV-14) filter sufficient to increase effective air changes per hour to 12 based on the clean air delivery rate measured in cubic feet per minute of the box fan + filter * 60 divided by the room volume.
• UV Germicidal Irradiation Lamp Unit
Classrooms assigned to this arm will be equipped with one or two 222nm wavelength light ultraviolet germicidal irradiation lamp units (number of units per classroom based on room volume).
• Combined: Box Fan and UV Germicidal Irradiation Lamp Units
Classrooms assigned to this arm will be equipped with both box fans and UV germicidal irradiation lamp units.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	Centers for Disease Control and Prevention, International Centre for Diarrhoeal Disease Research, Bangladesh

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of symptomatic respiratory illness episodes due to either Influenza or SARS- CoV-2	Study personnel will visit each school twice weekly. They will identify any students within the study classrooms who were absent or who have symptoms consistent with the World Health Organization (WHO) definition of influenza like illness. For children who were absent or who have symptoms, study personnel will visit the child's home, and if the student's parent provides informed consent, collect more detailed information on signs and symptoms, and a throat swab from the child. The throat swab will be placed on viral transport media, placed on ice and transported to the One Health Laboratory at the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b). One aliquot from the specimen will be analyzed for Influenza A, Influenza B, and SARS-CoV-2. In the laboratory, nucleic acid in the throat swab specimen will be extracted and one-step real-time (RT)-PCR conducted to assess the presence of RNA from Influenza A, Influenza B or SARS-CoV-2.	Over 40 weeks of observation
Secondary	Total number of symptomatic influenza-like illness episodes	Study personnel will visit each school twice weekly. They will identify any students within the study classrooms who were absent or who have symptoms consistent with the WHO definition of influenza like illness.	Over 40 weeks of observation
Secondary	Total number of symptomatic influenza episodes	Study personnel will visit each school twice weekly. They will identify any students within the study classrooms who were absent or who have symptoms consistent with the WHO definition of influenza like illness. For children who were absent or who have symptoms, study personnel will visit the child's home, and if the student's parent provides informed consent, collect more detailed information on signs and symptoms, and a throat swab from the child. The throat swab will be placed on viral transport media, placed on ice and transported to the One Health Laboratory at icddr,b. One aliquot from the specimen will be analyzed for Influenza A or Influenza B. In the laboratory, nucleic acid in the throat swab specimen will be extracted and one-step real-time RT-PCR conducted to assess the presence of RNA from Influenza A or Influenza B.	Over 40 weeks of observation
Secondary	Total number of symptomatic SARS-CoV2 episodes	Study personnel will visit each school twice weekly. They will identify any students within the study classrooms who were absent or who have symptoms consistent with the WHO definition of influenza like illness. For children who were absent or who have symptoms, study personnel will visit the child's home, and if the student's parent provides informed consent, collect more detailed information on signs and symptoms, and a throat swab from the child. The throat swab will be placed on viral transport media, placed on ice and transported to the One Health Laboratory at icddr,b. One aliquot from the specimen will be analyzed for SARS-CoV2. In the laboratory, nucleic acid in the throat swab specimen will be extracted and one-step real-time RT-PCR conducted to assess the presence of RNA from SARS-CoV2.	Over 40 weeks of observation
Secondary	Total number of student absentee episodes	Study personnel will visit each school twice weekly. They will identify any students within the study classrooms who were absent.	Over 40 weeks of observation