Status:
COMPLETED
COVID-19 Staff Testing of Antibody Responses Study (Co-Stars)
Lead Sponsor:
Great Ormond Street Hospital for Children NHS Foundation Trust
Conditions:
SARS-CoV-2 Infection
Eligibility:
All Genders
18+ years
Brief Summary
This study will perform prospective repeated serological antibody testing on a cohort of at least 1000 healthcare workers at Great Ormond Street Hospital. Within this cohort, a subset of 150-250 staff...
Detailed Description
A total of 250 healthcare workers are currently off sick with symptoms of SARS-CoV-2 infection (COVID-19) while 99 additional members of staff have been diagnosed with confirmed SARS-CoV-2 at Great Or...
Eligibility Criteria
Inclusion
- Inclusion Criteria for ARM 1: SARS-CoV-2 Seropositive Cases:
- Healthcare worker at GOSH
- \>18 years of age
- ALL have confirmed detectable antibodies to SARS-CoV-2 infection on baseline screen
- Then can be recruited into either of the following sub-groups
- Core Group of PCR Confirmed Cases : Must have symptoms consistent with SARS-CoV-2 infection and SARS-CoV-2 PCR Positive
- Other SARS-CoV-2 Sero-positives: May have Symptoms consistent with SARS-CoV-2 infection and SARS-CoV-2 PCR Negative cases OR May have no symptoms consistent with SARS-CoV-2 infection and PCR Not Tested cases
- Inclusion Criteria for ARM 2: SARS-CoV-2 Seronegative Comparison Group :
- Healthcare worker at GOSH
- \>18 years of age
- ALL have confirmed negative antibodies to SARS-CoV-2 infection on baseline screen
- Then can be recruited into either of the following Sub-groups:
- Core Comparison Group: Have not had clinical symptoms consistent with SARS-CoV-2 infection\*
- Other Seronegatives: Have had symptoms of SARS-CoV-2 infection but have been tested and were PCR positive or negative but have not developed antibodies at 21 days
- Clinical Symptoms for SARS-CoV-2 infection are defined as one of:
- 1\) New and persistent cough 2) Confirmed temperatures of 37.8 and above 3) Anosmia
- General Exclusion Criteria :
- \<18 years of age
- On immunosuppressive or immunomodulatory medication that may impact test reliability
- Received any blood product including immunoglobulins after October 2019
- Has received convalescent sera as treatment
- Current diagnosis of a malignancy that may impact test reliability
- Those lacking capacity to provide informed consent
Exclusion
Key Trial Info
Start Date :
April 27 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 30 2022
Estimated Enrollment :
3502 Patients enrolled
Trial Details
Trial ID
NCT04380896
Start Date
April 27 2020
End Date
July 30 2022
Last Update
September 27 2022
Active Locations (1)
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1
Great Ormond Street Hospital
London, United Kingdom, WC1N 3JH