COVID-19 in care homes (VIVALDI)

Conditions

COVID-19 (SARS-CoV-2 infection) Infections and Infestations COVID-19 (SARS-CoV-2 infection)

Krutikov M, Stirrup O, Fuller C, Adams N, Azmi B, Irwin-Singer A, Sethu N, Hayward A, Altamirano H, Copas A, Shallcross L.

2023-12-053 citations

10.1016/j.jamda.2023.10.027

VIVALDI Cohort Profile: Using linked, routinely collected data and longitudinal blood sampling to characterise COVID-19 infections, vaccinations, and related outcomes in care home staff and residents in England.

Krutikov M, Bone D, Stirrup O, Bruton R, Azmi B, Fuller C, Lau M, Low J, Rastogi S, Monakhov I, Tut G, Fink D, Moss P, Hayward A, Copas A, Shallcross L.

2023-01-012 citations

10.12688/wellcomeopenres.20278.2

Profile of humoral and cellular immune responses to single doses of BNT162b2 or ChAdOx1 nCoV-19 vaccines in residents and staff within residential care homes (VIVALDI): an observational study.

Tut G, Lancaster T, Krutikov M, Sylla P, Bone D, Kaur N, Spalkova E, Bentley C, Amin U, Jadir AT, Hulme S, Butler MS, Ayodele M, Bruton R, Shrotri M, Azmi B, Fuller C, Irwin-Singer A, Hayward A, Copas A, Shallcross L, Moss P.

2021-08-1943 citations

10.1016/s2666-7568(21)00168-9

Study Protocol: Understanding SARS-Cov-2 infection, immunity and its duration in care home residents and staff in England (VIVALDI).

Krutikov M, Palmer T, Donaldson A, Lorencatto F, Forbes G, Copas A, Robson J, Hopkins S, Moss P, Farrar J, Hayward A, Shallcross L.

2020-01-0131 citations

10.12688/wellcomeopenres.16193.2

Interventions

Current interventions as of 10/02/2021: This study will enrol >5000 care home residents and >6500 care home staff from approximately 350 care homes in England between June 2020 and April 2022. Eligibl

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: None

Design outcomes

Primary

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

Secondary

Measure	Time frame
1. Proportion of staff and residents who become infected during an outbreak measured using PCR and antibody testing of samples taken at baseline and 7-14 days after baseline 2. Proportion of staff and residents in a care home with asymptomatic infection measured using PCR testing of swab samples taken at baseline, 7-14 days after baseline and 7-14 days after the second swab 3. Duration of antibody response in residents measured using antibody testing 4-6 weeks and 3 months after the last swab test in those who tested positive for virus infection and at 6 and 12 months follow-up in those who tested positive for antibodies at 3 months 4. Proportion of care home staff and residents who have been infected with SARS-CoV-2 measured using PCR of swab tests taken at baseline and 7-14 days later in all participants, and 7-14 days after the second swab in homes where there has been infection 5. Number of residents discharged from hospital to the home assessed using linkage to hospital episode statistics at regular intervals throughout the study 6. Sensitivity and specificity of the Roche/Abbott antibody testing platform assessed using serum samples from all study participants at baseline, 4-6 weeks and 3 months 7. Sensitivity and specificity of the novel ELISA test for immunoglobulins IgG and IgM that has been developed by the University of Oxford assessed using a subset of 20% of all serum samples taken over the study period that will be tested retrospectively after they have had standard testing on the Abbott/Roche platforms 8. Sensitivity and specificity of RT-PCR based detection of SARS-CoV-2 using saliva samples versus nasopharyngeal swabs assessed using a subset of samples from 4-8 care homes from consenting participants at the second or third round of swabbing Added 10/02/2021: 9. Incidence of infection in vaccinated and unvaccinated participants (based on serology and PCR testing) in the 12 months following vaccination	—

Measure

Time frame

1. Proportion of staff and residents who become infected during an outbreak measured using PCR and antibody testing of samples taken at baseline and 7-14 days after baseline 2. Proportion of staff and residents in a care home with asymptomatic infection measured using PCR testing of swab samples taken at baseline, 7-14 days after baseline and 7-14 days after the second swab 3. Duration of antibody response in residents measured using antibody testing 4-6 weeks and 3 months after the last swab test in those who tested positive for virus infection and at 6 and 12 months follow-up in those who tested positive for antibodies at 3 months 4. Proportion of care home staff and residents who have been infected with SARS-CoV-2 measured using PCR of swab tests taken at baseline and 7-14 days later in all participants, and 7-14 days after the second swab in homes where there has been infection 5. Number of residents discharged from hospital to the home assessed using linkage to hospital episode statistics at regular intervals throughout the study 6. Sensitivity and specificity of the Roche/Abbott antibody testing platform assessed using serum samples from all study participants at baseline, 4-6 weeks and 3 months 7. Sensitivity and specificity of the novel ELISA test for immunoglobulins IgG and IgM that has been developed by the University of Oxford assessed using a subset of 20% of all serum samples taken over the study period that will be tested retrospectively after they have had standard testing on the Abbott/Roche platforms 8. Sensitivity and specificity of RT-PCR based detection of SARS-CoV-2 using saliva samples versus nasopharyngeal swabs assessed using a subset of samples from 4-8 care homes from consenting participants at the second or third round of swabbing Added 10/02/2021: 9. Incidence of infection in vaccinated and unvaccinated participants (based on serology and PCR testing) in the 12 months following vaccination

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Countries

England, United Kingdom

Contacts

Public ContactMaria Krutikov

m.krutikov@ucl.ac.uk-

Outcome results

None listed