COVID-19 Staff Testing of Antibody Responses Study (Co-Stars)
- Conditions
- SARS-CoV-2 Infection
- Interventions
- Other: Blood testOther: Standardised questionnaires
- Registration Number
- NCT04380896
- 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 members with confirmed (PCR positive) SARS-CoV-2 disease will be followed with intensive monthly testing for 6 months to determine whether antibody levels in the blood are maintained or decrease during this time. All 1000 recruited healthcare workers will be followed 6-monthly
- 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 Ormond Street Hospital. As a consequence, all routine surgery, out-patient activity and day cases have been postponed or cancelled altogether. It is therefore critical for us to understand whether or not this disease will continue to threaten staff health or whether natural infection will give rise to long lasting immunity.
This is a 2-arm prospective cohort study recruiting at least 1000 healthcare workers at GOSH over 6 years.Staff will be recruited and coordinated from each department to be representative of the full diversity of healthcare workers at the Trust. The age distribution of the participants will be monitored on a weekly, basis against the known age distribution of the hospital to ensure that the sample is representative.
Trust communications team will send an all staff email to inform them about this research project asking them to get in touch with the study team if they wish to participate and they meet the basic eligibility criteria. Potential participants will be asked voluntarily to attend a face to face appointment in person (or if preferred by telephone or 1:1 video teleconference meeting) to enable trained study staff to seek informed consent before they enter the study. Informed consent will be undertaken by study staff who are Good Clinical Practice trained, Human Tissue Act trained, study trained, GOSH consent trained and registered in the study log.
The consent process will specifically cover the reason for the study, the storage of samples and agreement for future samples to be tested once improved testing is made available. Once the member of staff has provided informed consent, they will be asked to undertake an online questionnaire in which they will record demographic details including age, sex, email address and telephone contact for results and coordinating follow up. The questionnaire will also record details of SARS-CoV-2 like symptoms, contact with SARS-CoV-2, pre-existing co-morbidities and medication or treatments that may interfere with serological testing.
After providing informed consent, the staff members then be asked attend the study phlebotomy testing clinic. Appointments will be 20 minutes in length but actual blood sampling for serological testing will be 5-10 minutes to allow plenty of time and space for staff members to be tested to maintain social distancing. A total of 8ml of blood will be stored for testing.
Follow up sampling and questionnaires of approximately 200 staff members with PCR confirmed SARS-CoV-2 infected staff will take place monthly. While follow up of all \~800 asymptomatic staff members will take place 6 monthly. All staff will continue to have access to the GOSH PCR COVID19 testing program (as they do at present). This will enable us to confirm with PCR testing any new (or reinfected) positive staff member with COVID-19 over the duration of the study.
When initially asymptomatic seronegative staff become serologically positive during the course of the study, they will remain under active surveillance but they will switch arms of the study and they will contribute to the active follow up of serologically positive patients.
If staff leave the GOSH NHS trust during the study they will still be eligible to remain in the study and be followed up and we will update their contact details on the follow-up questionnaire.
After the initial intensive phase, all approximately 1000 recruits will be followed 6 monthly for the 6 year duration of the study. Follow-up visits will be arranged following the baseline assessment. The same blood tests 4ml EDTA and 4ml serum will be taken at each follow up appointment as well as the same symptom questionnaire.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3502
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SARS-CoV-2 Seropositive Cases Blood test It will be formed of approximately N= 200 to 350 staff members Core Group of PCR Confirmed Cases N \~ 150 to 250: A) Symptoms consistent with SARS-CoV-2 infection and SARS-CoV-2 PCR Positive N \~ 150 to 250 OR Other SARS-CoV-2 Sero-positives N \~ 50 to 100: B) Symptoms consistent with SARS-CoV-2 infection and SARS-CoV-2 PCR Negative cases. OR C) No symptoms consistent with SARS-CoV-2 infection and PCR Not Tested cases SARS-CoV-2 Seronegative Comparison Group Standardised questionnaires It will be formed of approximately N= 800 to 900 staff members Core Comparison Group N \~ 800 A) Have not had clinical symptoms consistent with SARS-CoV-2 infection OR Other Seronegatives N \~ 100 B) Have had sympoms of SARS-CoV-2 infection but have been tested and were PCR positive or negative but have not developed antibodies at 21 days SARS-CoV-2 Seropositive Cases Standardised questionnaires It will be formed of approximately N= 200 to 350 staff members Core Group of PCR Confirmed Cases N \~ 150 to 250: A) Symptoms consistent with SARS-CoV-2 infection and SARS-CoV-2 PCR Positive N \~ 150 to 250 OR Other SARS-CoV-2 Sero-positives N \~ 50 to 100: B) Symptoms consistent with SARS-CoV-2 infection and SARS-CoV-2 PCR Negative cases. OR C) No symptoms consistent with SARS-CoV-2 infection and PCR Not Tested cases SARS-CoV-2 Seronegative Comparison Group Blood test It will be formed of approximately N= 800 to 900 staff members Core Comparison Group N \~ 800 A) Have not had clinical symptoms consistent with SARS-CoV-2 infection OR Other Seronegatives N \~ 100 B) Have had sympoms of SARS-CoV-2 infection but have been tested and were PCR positive or negative but have not developed antibodies at 21 days
- Primary Outcome Measures
Name Time Method Change in serial monthly log-transformed antibody titre levels as measured 6 months period post infection To determine the kinetics (rate of change) of SARS-CoV-2 nucleo-capsid protein antibody titres in proven cases of SARS-CoV-2 over the 6 month period following infection
- Secondary Outcome Measures
Name Time Method The immune correlates of protection against future exposure to SARS-CoV-2 Between 3 to 6 years To determine the immune correlates of protection (Antibody Titres sufficient for protection) against future exposure to SARS-CoV-2
Proportion of completely asymptomatic healthcare workers with evidence of SARS-CoV-2 antibodies 12 months To determine the proportion of completely asymptomatic healthcare workers who have evidence of SARS-CoV-2 antibodies in their serum indicative of past infection
The attack rate of SARS-CoV-2 in healthcare workers who have antibodies compared to those who do not Betwen 3 to 6 years To determine the attack rate of SARS-CoV-2 in healthcare workers who have antibodies versus those who do not have antibodies
Trial Locations
- Locations (1)
Great Ormond Street Hospital
🇬🇧London, United Kingdom