COVID-19 Antibody and Reinfection Study

COVID-19 Testing Clinical Trial

Official title:

COVID-19 Antibody and Reinfection Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05365750
• Other study ID #: 1589316-19
• Status: Active, not recruiting
• Start date: June 15, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4235
• Est. completion date: December 31, 2024
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria are:

• KPCO health plan members,

• 18 years and older,

• Have a valid email address or phone number in the electronic health record.

Exclusion criterion:

• Being on the Do Not Call List for research.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Testing

Locations

Country	Name	City	State
United States	Kaiser Permanente	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody result	Qualitative and semi-quantitative antibody results from participants over time	April 2020 - January 2022
Secondary	Reinfections	COVID reinfection based on viral testing	April 2020 - January 2022