Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-01 @ 7:27 PM
Study NCT ID:
NCT05365750
Status:
COMPLETED
Last Update Posted:
2025-09-18
First Post:
2022-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
COVID-19 Antibody and Reinfection Study
Sponsor:
Kaiser Permanente
Organization:
Study Overview
Official Title:
COVID-19 Antibody and Reinfection Study
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: