COVID-19 Staff Testing of Antibody Responses Study (Co-Stars)

NCT04380896 | Completed

• 1 other identifier: 20CB17
• Study Type: observational
• Target: 3,502
• Locations: 1 country
• Sites: 1

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

Conditions

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• Change in serial monthly log-transformed antibody titre levels as measured

  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

  6 months period post infection

Secondary Outcomes (3)

• Proportion of completely asymptomatic healthcare workers with evidence of SARS-CoV-2 antibodies

  12 months

• The attack rate of SARS-CoV-2 in healthcare workers who have antibodies compared to those who do not

  Betwen 3 to 6 years

• The immune correlates of protection against future exposure to SARS-CoV-2

  Between 3 to 6 years

Study Arms (2)

SARS-CoV-2 Seropositive Cases

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

Other: Blood test; Other: Standardised questionnaires

SARS-CoV-2 Seronegative Comparison Group

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

Other: Blood test; Other: Standardised questionnaires

Interventions

Blood test OTHER

Blood tests (8ml in total) 4ml blood for serological testing (measure the antibody titres to the SARS-CoV-2 nucleo-capsid protein (4ml) and 4ml EDTA to be stored for future research will be taken for each group.

SARS-CoV-2 Seronegative Comparison Group; SARS-CoV-2 Seropositive Cases

Standardised questionnaires OTHER

It will be an online questionnaire about staff members health, symptoms of SARS-CoV-2 and contact with SARS-CoV-2. All participants will also be asked to complete a detailed symptom and electronic questionnaire prior to each appointment.

SARS-CoV-2 Seronegative Comparison Group; SARS-CoV-2 Seropositive Cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population will comprise frontline healthcare workers selected to be representative of all departments at Great Ormond Street Hospital. The researcher will ensure that equal numbers of men and women are recruited from each department and that age ranges are representative of the trust population age distribution.We will also check the age distribution of the participants on a weekly basis during recruitment against the known age distribution of the hospital to ensure that our sample is representative. If significant differences among ages between the study population and the hospital population age range emerge then we will actively recruit from those age ranges that we have inadequately sampled.

You may qualify if:

• 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
• 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:
• \) New and persistent cough 2) Confirmed temperatures of 37.8 and above 3) Anosmia

You may not qualify if:

• \<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

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead

Study Sites (1)

Great Ormond Street Hospital

London, WC1N 3JH, United Kingdom

Location

Related Publications (4)

• Lam T, Saso A, Torres Ortiz A, Hatcher J, Woodman M, Chandran S, Thistlethwayte R, Best T, Johnson M, Wagstaffe H, Mai A, Buckland M, Gilmour K, Goldblatt D, Grandjean L; COVID-19 Staff Testing of Antibody Responses (Co-STARs) Study Team. Socioeconomic and Demographic Risk Factors for SARS-CoV-2 Seropositivity Among Healthcare Workers in a UK Hospital: A Prospective Cohort Study. Clin Infect Dis. 2024 Mar 20;78(3):594-602. doi: 10.1093/cid/ciad522.

  PMID: 37647517 DERIVED

• Torres Ortiz A, Fenn Torrente F, Twigg A, Hatcher J, Saso A, Lam T, Johnson M, Wagstaffe H, Dhillon R, Mai AL, Goldblatt D, Still R, Buckland M, Gilmour K, Grandjean L. The influence of time on the sensitivity of SARS-CoV-2 serological testing. Sci Rep. 2022 Jun 22;12(1):10517. doi: 10.1038/s41598-022-14351-2.

  PMID: 35732870 DERIVED

• Ortiz AT, Torrente FF, Twigg A, Hatcher J, Saso A, Lam T, Johnson M, Wagstaffe H, Dhillon R, Mai AL, Goldblatt D, Still R, Buckland M, Gilmour K, Grandjean L. The Influence of Time on the Sensitivity of SARS-CoV-2 Serological Testing. Res Sq [Preprint]. 2022 Feb 17:rs.3.rs-1286644. doi: 10.21203/rs.3.rs-1286644/v1.

  PMID: 35194596 DERIVED

• Grandjean L, Saso A, Torres Ortiz A, Lam T, Hatcher J, Thistlethwayte R, Harris M, Best T, Johnson M, Wagstaffe H, Ralph E, Mai A, Colijn C, Breuer J, Buckland M, Gilmour K, Goldblatt D; COVID-19 Staff Testing of Antibody Responses Study (Co-Stars) team. Long-Term Persistence of Spike Protein Antibody and Predictive Modeling of Antibody Dynamics After Infection With Severe Acute Respiratory Syndrome Coronavirus 2. Clin Infect Dis. 2022 Apr 9;74(7):1220-1229. doi: 10.1093/cid/ciab607.

  PMID: 34218284 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Each sample will be tested using the EDITM diagnostic assay which detects the optical density of antibodies in serum samples to the nucleo-capsid protein SARS-CoV-2. Both IgM and IgG antibodies to the nucleo-capsid protein will be tested and reported. At the end of the study the samples will be stored at -70oC in the freezers of the Great Ormond Street Camelia Botnar Laboratories for future research. Future studies may involve genetic testing on the samples and this has been highlighted on the consent form.

MeSH Terms

Conditions

COVID-19

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Louis Grandjean, Dr

  Great Ormond Street Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 8, 2020
• Study Start: April 27, 2020
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: September 27, 2022

Record last verified: 2022-09

Locations

GB (1)