COVID-19 Antibody and Reinfection Study

Study Overview
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Brief Summary
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The goal of this study is to establish a cohort of Kaiser Permanente Colorado (KPCO) members who have and have not had COVID-19 infection for serial antibody testing and PCR testing to: Quantify antibody titers among participants over 9 months. Determine the rates of asymptomatic, mild, and severe recurrent infection among participants with prior COVID-19. Examine association between antibody titer levels and risk of recurrent infection using a case control analysis nested in the cohort.

Detailed Description
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In this study, the Kaiser Permanente Colorado (KPCO) Institute for Health Research (IHR) will evaluate SARS-CoV-2 IgG antibody titers over time among individuals with evidence of prior infection, and correlate antibody titers with risk of recurrent infection. The investigators will identify KPCO members who have and have not had prior infection, enroll them into a cohort study, conduct serial surveys for new COVID-19 symptoms, and facilitate serial viral and antibody testing. All laboratory testing procedures and clinical management of participants will be conducted by KPCO operations. The research team will identify participants, obtain consent, administer surveys to assess COVID-19 symptoms, and direct patients to the appropriate testing. Health outcomes on cohort participants will be tracked with survey data on symptoms, clinical and utilization data from the KPCO electronic health record (e.g., hospitalization), and laboratory data (e.g., viral test results). This research-operations partnership strategy will generate data to better understand the implications of positive antibody titers to this novel pathogen.

Official Title
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COVID-19 Antibody and Reinfection Study

Conditions
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COVID-19 Testing

Participation Criteria
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Eligibility Criteria
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Inclusion criteria are: KPCO health plan members, 18 years and older, Have a valid email address or phone number in the electronic health record. Exclusion criterion: • Being on the Do Not Call List for research.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case<br>The COVID-19 case group is a random sample of individuals who are enrolled in KPCO's health plan who are cases or likely cases. These individuals may have positive antibodies to COVID-19. | |
| Control<br>A random stratified sample of the general KPCO membership with similar age, gender, race/ethnicity and co-morbidities as case group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody result | Qualitative and semi-quantitative antibody results from participants over time | April 2020 - January 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reinfections | COVID reinfection based on viral testing | April 2020 - January 2022 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2