COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult, adolescent or child aged 2 years or older, male or female 2. Currently resident in a household where a household member has participated in an ONS or NISRA Survey and has consented to be approached for future research or where the household has been randomly selected from databases of addresses. ‘Currently resident’ is defined according to 2011 Census definitions, specifically, a ‘resident’ is defined as a person who typically stays overnight in the address at least 4 nights out of 7 and a ‘household’ is defined as one person living alone; or a group of people (not necessarily related) living at the same address who share cooking facilities and share a living room or sitting room or dining area 3. If 16 years or older: Participant is willing and able to give informed consent for participation in the study. 4. If 2-15 years at last birthday: A parent/carer is able to give informed consent for participation in the study; those aged 10 years and older should also provide assent.
Exclusion criteria
Exclusion criteria: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 28/02/2023: Presence vs absence of SARS-CoV-2 virus assayed from a nose and throat swab using a polymerase chain reaction (PCR) test, every calendar day from the start of the study until study end (note: the outcome measure is at the population level, not the individual level as this is a surveillance study), with analysis based on continuous time and the latest test available in the prior 2 weeks. Previous primary outcome measure: Presence vs absence of SARS-CoV-2 virus assayed from a nose and throat swab using a polymerase chain reaction (PCR) test, every calendar week from the start of the study for 1 year (note: the outcome measure is at the population level, not the individual level as this is a surveillance study) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 28/02/2023: 1. Incidence of new presence of SARS-CoV-2 virus measured from a nose and throat swab using a PCR test, separately in previously negative and previously virus-positive individuals (to estimate re-infection after clearing the virus), every calendar day from the start of the study until study end 2. Immunity to SARS-CoV-2 measured from blood using an enzyme-linked immunosorbent assay for IgG antibodies, every calendar day from the start of the study until the study end, with analysis based on continuous time and the latest test available in the last month. 3. Presence or absence of SARS-CoV-2 virus assayed from nose and throat swabs taken from different members of the same household, for each household visit 4. Concentrations and thresholds of IgG to SARS-CoV-2 assayed from the blood of different members of the same household, for each household visit 5 Inpatient admissions measured from centrally stored hospital records (Hospital Episode Statistics) up to 15 years from the final study visit 6. Outpatient attendances measured from centrally stored hospital records (Hospital Episode Statistics) up to 15 years from the final study visit 7. A&E attendances measured from centrally stored hospital records (Hospital Episode Statistics) up to15 years from the final study visit 8. Consultations with a General Practitioner measured from centrally stored hospital records (Hospital Episode Statistics) up to 15 years from the final study visit 9. Overall mortality and cause of death as measured from centrally stored records (Office for National Statistics) up to 15 years from the final study visit Previous secondary outcome measures: 1. Incidence of new presence of SARS-CoV-2 virus measured from a nose and throat swab using a PCR test, separately in prev | — |
Countries
England, United Kingdom