COVID-19 Antibody and Reinfection Study

Active, not recruiting

• 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.

Study Timeline

• Study Start: 2020-06-15
• Study First Submitted: 2022-05-05
• Study First Submitted QC: 2022-05-05
• Study First Posted: 2022-05-09
• Primary Completion: 2023-03-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-03-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 4235

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antibody result	April 2020 - January 2022	Qualitative and semi-quantitative antibody results from participants over time

Secondary Outcome Measures

Name	Time	Method
Reinfections	April 2020 - January 2022	COVID reinfection based on viral testing

Trial Locations

Locations (1)

Kaiser Permanente; 🇺🇸 Aurora, Colorado, United States