COVID-19 in care homes (VIVALDI)

Not Applicable

Completed

• Conditions: COVID-19 (SARS-CoV-2 infection); Infections and Infestations

• Registration Number: ISRCTN14447421
• Lead Sponsor: niversity College London

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33564722/ protocol (added 05/02/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34174193/ first dose results (added 28/06/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34430954/ observational cohort sub-study (added 26/08/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35813279/ duration of vaccine effectiveness results (added 13/07/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36713473/ effectiveness of booster vaccine against omicron infection (added 31/01/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38065220/ Association between built environment and SARS-CoV-2 transmission in care homes (added 11/12/2023) 2023 Preprint results in https://wellcomeopenresearch.org/articles/8-553 description of samples in the study biobank available to researchers (added 08/03/2024) 2024 Preprint results in https://wellcomeopenresearch.org/articles/9-45 humoral response to anti-nucleocapsid antibody associated with natural infection (added 08/03/2024) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34794537/ Changes in COVID-19 outbreak severity and duration (added 08/03/2024) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35429382/ anti-spike antibody levels following second dose of ChAdOx1 nCov-19 or BNT162b2 vaccine (added 08/03/2024) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/34104901/ association between the SARS-CoV-2 antibody status at baseline and subsequent infection (added 08/03/2024) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37595069/ effectiveness of third, fourth and fifth dose booster vaccination (added 08/03/2024) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35813280/ infection-naive residents (added 08/03/2024) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37949372/ mortality and hospital admissions (added 08/03/2024) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34935001/ prevalence and duration of antibodies from the first year of the pandemic (added 08/03/2024) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35531432/ risk of severe outcomes following infection (added 08/03/2024) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37118525/ spike-specific immune responses in staff and residents in LTCF receiving an mRNA vaccine following dual primary series vaccination with BNT162b2 or ChAdOx1 (added 08/03/2024) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/37118449/ vaccine-naïve residents (added 08/03/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-05
• Study Completion: 2023-03-31
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10412

Inclusion Criteria

Current participant inclusion criteria as of 01/04/2022:
Staff and residents aged >65 years from participating care homes in England

Previous participant inclusion criteria:
1. Staff and residents aged >65 years from participating Four Seasons Health Care (FSHC) Homes in England
2. Can speak and understand English

Exclusion Criteria

None

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Proportion of care home staff and residents who have been infected with SARS-CoV-2 measured using antibody testing at baseline