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Project REMOTE (REimagining Measurements and Operations of Translational Endpoints)
Sponsor: Biomedical Advanced Research and Development Authority
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
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.
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