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ACTIVE NOT RECRUITING
NCT06776367

Project REMOTE (REimagining Measurements and Operations of Translational Endpoints)

Sponsor: Biomedical Advanced Research and Development Authority

View on ClinicalTrials.gov

Summary

This trial is designed to assess immunological biomarkers measured from blood samples that can be used to reliably predict how well vaccines work against symptomatic COVID-19 as well as to evaluate the feasibility of remote, self-collected specimens when conducting a correlates analysis. For a lot of research studies, people need to go to the study doctor's office regularly. For this study, we want to see if it is okay that people do the study doctor visits virtually, fill out questionnaires electronically, and collect their own samples remotely. Participants will enroll in the study after receiving a COVID-19 vaccine in their community, and saliva and blood specimens will be collected at pre-defined time-points over a 12-month period. Additionally, participants will report weekly whether they experience symptoms of COVID-19, and if so, will be prompted to collect a nasal swab for testing. Most participants will complete all activities remotely and via electronic communications, but a small number will complete activities in person at the doctor's office to provide a comparison group. Samples from the study will be analyzed to determine whether the biomarkers can be measured, and data from the study will be used to evaluate the feasibility of doing the specimen and data collection without the participant going to the doctor's office in person.

Official title: Longitudinal Assessment of Potential Immunologic Correlates of Risk and Protection Following COVID-19 Vaccination Comparing Remote and Site-based Specimen Collection (Feasibility, Validity, and Proof of Concept)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

4000

Start Date

2024-12-20

Completion Date

2026-07

Last Updated

2025-09-17

Healthy Volunteers

Yes

Conditions

Interventions

OTHER

Remote study participation and self-collection of specimens

Participants in Group B will complete all study procedures remotely and will not physically visit any clinical research site. This will include telehealth (videoconference) visits with study personnel, self-collection of specimens, shipping of specimens using pre-labeled packaging, and completion of electronic diaries for data collection.

OTHER

Traditional clinical trial participation with clinician-collected specimens

Participants in Group A will attend study visits in person at a clinical research site and will have the majority of specimens collected by a clinician at the clinic. Group A participants will have some electronic diary usage.

Locations (16)

Accel Research Site Networks - Birmingham CRU / Elite

Vestavia Hills, Alabama, United States

Desert Clinical Research

Mesa, Arizona, United States

Apex Research Group

Fair Oaks, California, United States

Wake Research Encino

Los Angeles, California, United States

Wake Research San Diego

San Diego, California, United States

Research Institute of South Florida

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

Wake Research Atlanta

Atlanta, Georgia, United States

Johnson County Clinical Trials (JCCT)

Lenexa, Kansas, United States

Research Integrity / WCG

Owensboro, Kentucky, United States

Alcanza / hyperCORE

Boston, Massachusetts, United States

Be Well Clinical Studies / Elite

Lincoln, Nebraska, United States

SUNY / Upstate Medical University Global Health Institute

Syracuse, New York, United States

Kroger The Little Clinic (Remote Site)

Blue Ash, Ohio, United States

Lynn Health Science Institute East / Elite

Oklahoma City, Oklahoma, United States

Wake Research Dallas

Dallas, Texas, United States