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COVID-19 Antibody and Reinfection Study

Sponsor
Kaiser Permanente (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05365750
Collaborator
(none)
4,235
Enrollment
1
Location
27.5
Anticipated Duration (Months)
154
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study is to identify Kaiser Permanente Colorado (KPCO) members who have had

COVID-19 infection for serial antibody testing and PCR testing to:

  1. Quantify antibody titers among previously infected COVID-19 participants over 9 months.

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

  3. Examine association between antibody titer levels and risk of recurrent infection.

We will also identify KPCO members from the overall membership did not have any evidence of COVID-19 infection as a comparison group. In these participants we will also conduct serial antibody and viral testing and measure infection rates. This will allow us to compare whether participants with and without antibodies have different rates of infection.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    4235 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    COVID-19 Antibody and Reinfection Study
    Actual Study Start Date :
    Jun 15, 2020
    Anticipated Primary Completion Date :
    Sep 30, 2022
    Anticipated Study Completion Date :
    Sep 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Case

    The case group is a random sample of individuals who are enrolled in KPCO's health plan who are "cases" or "likely cases" in which the antibody positive rate is likely to be higher than the general membership:
    Control

    A random stratified sample of the general KPCO membership with similar age, gender, race/ethnicity and co-morbidities as case group

    Outcome Measures

    Primary Outcome Measures

    1. Antibody result [April 2020 - January 2022]

      Qualitative and semi-quantitative antibody results from participants over time

    Secondary Outcome Measures

    1. Reinfections [April 2020 - January 2022]

      COVID reinfection based on viral testing

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion:

    • Member on KPCO health plan

    • 18 years old or older

    • Have a valid email address OR phone number

    Exclusion:

    • On the Do Not Call List for research

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaiser Permanente Aurora Colorado United States 80014

    Sponsors and Collaborators

    • Kaiser Permanente

    Investigators

    • Principal Investigator: Ingrid Binswanger, MD, MPH, MS, Kaiser Permanente

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ingrid Binswanger, Senior Investigator, Kaiser Permanente
    ClinicalTrials.gov Identifier:
    NCT05365750
    Other Study ID Numbers:
    • 1589316-19
    First Posted:
    May 9, 2022
    Last Update Posted:
    May 13, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ingrid Binswanger, Senior Investigator, Kaiser Permanente
    SARS-CoV-2
    Additional relevant MeSH terms:
    COVID-19
    Reinfection

    Study Results

    No Results Posted as of May 13, 2022