COVID-19 Testing
Conditions
Keywords
SARS-CoV-2
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.
Interventions
None listed
Sponsors
Kaiser Permanente
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
are Kaiser Permanente Colorado health plan members, with a valid email address or phone number in the electronic health record and not on the Do Not Call List for research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited into a cohort from the health plan membership from June 2020 to March 2021 using text message and emails linked to online consent documents. From this cohort, we conducted a nested case control analysis in which participants with the outcome were compared to participants without the outcome.
Pre-assignment details
As is standard in a nested case-control study, the cohort is used to identify a sufficient sample to conduct the case-control analysis, in which people with the outcome of interest are compared with people who did not have the outcome. The protocol section describes the recruited cohort (n=4235) and the results section describe participants in the case-control (n=1114). Participants not in the case-control (n=3121) are not in the participant flow because their data were not analyzed.
Participants by arm
| Arm | Count |
|---|---|
| Case Patients Nested Within the Cohort Case patients had a reinfection, defined as a positive SARS-CoV-2 RNA test ≥ 90 days after the first positive RNA. Case patients had serology completed between the infections. | 80 |
| Control Patients Nested Within the Cohort Control patients had a primary infection and serologic tests that were conducted between the primary infection and the index date. A control patient could be matched to more than one case patient if they had more than one eligible serologic test. Case patients were 1:20 matched to controls. | 1,034 |
| Total | 1,114 |
Baseline characteristics
| Characteristic | Case Patients Nested Within the Cohort | Control Patients Nested Within the Cohort | Total |
|---|---|---|---|
| Age, Continuous | 52.7 years STANDARD_DEVIATION 12.7 | 54.4 years STANDARD_DEVIATION 11.9 | 54.3 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants | 252 Participants | 284 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 782 Participants | 830 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Negative serologic test | 12 participants | 77 participants | 89 participants |
| Sex: Female, Male Female | 60 Participants | 761 Participants | 821 Participants |
| Sex: Female, Male Male | 20 Participants | 273 Participants | 293 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 1,034 |
| other Total, other adverse events | 0 / 80 | 0 / 1,034 |
| serious Total, serious adverse events | 0 / 80 | 0 / 1,034 |
Outcome results
Primary
Reinfection With SARS-CoV-2
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.
Time frame: Through the completion of the study analytic period, an average of 6 months
Population: Study cohort members with a primary SARS-CoV-2 infection
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Case Patients | Reinfection With SARS-CoV-2 | Seronegative test results | 12 Participants |
| Case Patients | Reinfection With SARS-CoV-2 | Seropositive test results | 68 Participants |
| Control Patients | Reinfection With SARS-CoV-2 | Seronegative test results | 77 Participants |
| Control Patients | Reinfection With SARS-CoV-2 | Seropositive test results | 957 Participants |