COVID-19 Antibody and Reinfection Study
- 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
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reinfection With SARS-CoV-2 Through 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
Name Time Method
Trial Locations
- Locations (1)
Kaiser Permanente
🇺🇸Aurora, Colorado, United States
Kaiser Permanente🇺🇸Aurora, Colorado, United States
