SARS-CoV2 Infection Clinical Trial
Official title:
Reducing Respiratory Virus Transmission in Bangladeshi Classrooms
NCT number | NCT06247059 |
Other study ID # | 73657 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2024 |
Est. completion date | March 2026 |
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.
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Stanford University | Centers for Disease Control and Prevention, International Centre for Diarrhoeal Disease Research, Bangladesh |
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 |
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