Ignite Creation Date:
2024-05-06 @ 2:39 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04380896
Status:
COMPLETED
Last Update Posted:
2022-09-27
First Post:
2020-05-04
Brief Title:
COVID-19 Staff Testing of Antibody Responses Study Co-Stars
Sponsor:
Great Ormond Street Hospital for Children NHS Foundation Trust
Organization:
Great Ormond Street Hospital for Children NHS Foundation Trust
Study Overview
Official Title:
COVID-19 Staff Testing of Antibody Responses Study CO-STARS
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Co-Stars
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 yearsStaff 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 11 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
This is a 2-arm prospective cohort study recruiting at least 1000 healthcare workers at GOSH over 6 yearsStaff 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None