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Recruiting NCT05271669

COVID-19 Immunity and Changes Over Time

Observational COVID-19

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: COVID-19. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Patterns of SARS-CoV-2 Immunity at Household Level and Their Changes Over Time

Overview

The risk of household spread of SARS-CoV-2 hinges on both the transmission dynamics of the virus circulating in the community as well as the seroprotection pattern of constituent members, which can be attributed to vaccination and previous infections. This study is conceptualised to assess the dynamicity of SARS-CoV-2 risk at the household level, through monitoring the pattern of seroprotection, in conjunction with the vaccination coverage, history of infection and exposure risk in the setting of Hong Kong.

Detailed description

The aim of this study is to assess the SARS-CoV-2 risk at the household level, with the objectives of (a) determining the coverage of vaccination and its changes over time; (b) monitoring pattern of exposure and history of infection; and (c) evaluating the level of seroprotection and its longitudinal trend.

A cohort of households comprising 900 persons would be recruited. Invited participants would be attend the Research Centre for blood sampling and the completion of a simple questionnaire at 3 different timepoints at 12-18 months apart. A questionnaire would be administered to capture the following characteristics: (a) Socio-demographics; (b) History of SARS-CoV-2 infection; (c) adoption of precautionary measures; (d) SARS-CoV-2 testing history and (e) SARS-CoV-2 vaccination uptake.

Participants would be tested for SARS-CoV-2 serology. The main markers for measurement are nucleocapsid antibody for inferring past infection, spike antibody for the immunological responses, and seroprotection by SARS-CoV-2 surrogate virus neutralisation test.

Primary outcome measures

  • Proportion of participants with COVID-19 protective immunity [Time frame: 1 year]
  • Proportion of participants with marker of past COVID-19 infection [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • adults of age 18 or above, or children under the age of 18 with informed consent of the legal guardian
  • normally residing in Hong Kong
  • could communicate in spoken and written Chinese and/or English

Exclusion criteria

  • individuals with mental illness
  • prisoners

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Shui Shan Lee — Hong Kong

Identifiers

NCT: NCT05271669 · Protocol HK COVID cohort 2021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗