Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT05365750
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.
Study:
NCT05365750
Study Brief:
Protocol Section:
NCT05365750