COVID-19 trials registries data warehouse

https://www.isrctn.com/ISRCTN18100261

Saroj Kendrick

Saroj.Kendrick@dhsc.gov.uk

2021-05-04

Not recruiting

RCT

Randomized

Cluster

Not reported

single-center

Prevention

1. Secondary school/further education college 2. Willing and able to follow the study protocol 3. Willing and able to undertake PCR testing of contacts in the event the school is allocated to the control group 4. Commits to maintaining contact management in line with national standards 5. Willing and able to provide regular data of test results to Test and Trace and to allow members of an index case’s contact group to be flagged in a database. 6. Willing and able to support baseline data collection requirements (e.g., provision of school register, bubble allocation data, etc.) 7. Willing to communicate regularly to Participants via Participant Information Sheets and other communication materials 8. Willing and able to provide a dedicated DHSC-funded Research Assistant to support data collection Inclusion criteria for DCT (in the intervention arm): Staff (including temporary or contract staff) and students in secondary schools/further education colleges/year 7 and above in all-through schools’ individuals, who are: 1. Contact of a positive case related to school 2. Asymptomatic 3. Onsite i.e. not self-isolating or shielding 4. Contact of an index case in the school’s population i.e. a staff member or student who has tested positive

1. The school’s contact management policy does not conform to national standards 2. Inability to support in-school LFD testing (i.e. not part of the NHS Test and Trace Asymptomatic Testing Site network) Exclusion criteria for DCT (in the intervention arm): 1. Contact of a non-school index case 2. Household contact of a diagnosed COVID-19 positive individual 3. Symptomatic individuals

2

Department of Health and Social Care

8

100

United Kingdom

Healthy volunteers

N/A

200000

Co-Primary End-Points: 1. Number of school days missed among those eligible to be in school during the 9-week period of the study. Daily school attendances will be obtained from the school register and absences recorded with reconciliation with COVID-19 associated absences. This will be compared between study arms; to historic schools’ data; and to national schools’ benchmark data collected via a survey of non-participating schools. 2. Estimated number of in-school COVID-19 transmission events during the 9-week period of the study: the number of positive cases will be obtained from the following sources: 2.1. Weekly LFD active case finding (control and intervention arms) during the 9-week period of the study 2.2. Symptomatic individuals’ NHS Test and Trace results obtained from Community Testing routine data (control and intervention arms) during the 9-week period of the study 2.3. In-school LFD DCT testing (intervention arm) during the 9-week period of the study Positivity rates will be reported for each source separately to facilitate like-for-like comparison between arms Epidemiological links between cases will be obtained from the NHS Test & Trace Contact Tracing and Advice Service database. Additional links will be obtained by membership of school-reported contact groups. Onward transmission from the index case will be determined by the following: 1. Genomic sequence of virus: the additional PCR swab collected from positive individuals will be used to determine the whole genomic sequence of isolates. A sample of apparent links will be assessed with comparisons of whole-genome sequencing. The diversity of genetic sequences both in the schools and the community (routinely determined by COG) will be used to help interpret the results. Preliminary work currently undertaken will determine the appropriate genetic distance to be used to exclude a direct transmission event between individuals. This is likely to be two SNPs. 2. Plausible epidemiological link (e.g. membership of same close contact group) 3. For positive individuals identified in DCT the DMIC will review all available data to determine if the individual’s infection was likely to have resulted from onward transmission from the index case; or via co-infection from an unknown ‘upstream’ positive or out-of-school positive case.

Not reported

[{"arm_notes": "Mixed age group; 200 schools or colleges, average 1000 staff and students at each institution", "treatment_id": 374, "treatment_name": "Daily contact testing", "treatment_type": "Public health program", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]