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COVID-19 Antibody and Reinfection Study

Completed
Conditions
COVID-19 Testing
Registration Number
NCT05365750
Lead Sponsor
Kaiser Permanente
Brief Summary

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:

1. Quantify antibody titers among participants over 9 months.

2. Determine the rates of asymptomatic, mild, and severe recurrent infection among participants with prior COVID-19.

3. Examine association between antibody titer levels and risk of recurrent infection using a case control analysis nested in the cohort.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
4235
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Reinfection With SARS-CoV-2Through the completion of the study analytic period, an average of 6 months

In this case-control analysis, case patients were participants with the outcome of reinfection. The date of reinfection was the index date. Control patients were those with a primary infection but without the outcome reinfection by the index date. The case and control participants were compared with respect to a seronegative test result (exposure) after primary infection and closest in time to the index date. Because the cases and controls were selected on the basis of the outcome, the seronegative result is listed below by case and control status.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Kaiser Permanente

🇺🇸

Aurora, Colorado, United States

Kaiser Permanente
🇺🇸Aurora, Colorado, United States

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