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Early Pandemic Evaluation and Enhanced Surveillance of the coronavirus COVID-19 (EAVE II)

Not Applicable
Completed
Conditions
COVID-19 (SARS-CoV-2 infection)
Infections and Infestations
Registration Number
ISRCTN40292537
Lead Sponsor
Academic and Clinical Centre Office for Research and Development (ACCORD) (UK)
Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32565483/ protocol published at: 2021 Preprint results in http://dx.doi.org/10.2139/ssrn.3789264 non-peer-reviewed results (added 23/03/2021) 2022 Results article in https://doi.org/10.1016/S0140-6736(21)00677-2 (added 26/05/2022)

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
5400000
Inclusion Criteria

All (anonymised) patient data will be collected

Exclusion Criteria

Does not meet inclusion criteria

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<br> 1. Laboratory confirmed SARS-CoV-2 measured using virological/serological tests between baseline and 9 months<br> 2. Serum from blood samples taken from biochemistry tests (or rapid antibody tests if available) will be used to determine exposure to SARS-CoV-2 infection by the presence of antibodies between baseline and 9 months<br> 3. SARS-CoV-2 infection-related clinical outcomes including general practice, COVID-19 centres and out-of-hours consultations, hospital admissions including secondary bacterial infections and multidrug-resistant bacteria associated with these infections, emergency admissions, out of hours consultations, and deaths between baseline and 9 months<br>
Secondary Outcome Measures
NameTimeMethod
<br> 1. Vaccine uptake proportions measured using primary care practice and hospital data between baseline and 18 months<br> 2. Prevention and reduction of SARS-CoV-2 infection-related general practice consultations, hospital admissions including secondary bacterial infections, emergency admissions, out of hours consultations and deaths due to therapies, vaccines, and antimicrobials between baseline and 18 months<br> 3. Adverse events related to therapies, for example, vaccine, antimicrobial administration, or other therapies measured using participant data between baseline and 18 months<br>
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