Project REMOTE (REimagining Measurements and Operations of Translational Endpoints)

Running, not enrolling

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT06776367

Run by

Biomedical Advanced Research and Development Authority

People needed

4000

Starts

2024-12-20

Expected to finish

2026-07-01

Last updated by the study team

2025-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Are willing and able to provide voluntary electronic informed consent (eConsent) to participate in the study and written authorization (via electronic signature) for use and disclosure of protected health information
• Are able to understand and comply with planned study procedures, including specimen collection devices, use of eCOA application on a tablet or smartphone, and the wearable biometric device.
• Are ≥18 years old at time of informed consent
• Are available for all study data collection timepoints
• Completed primary approved/authorized COVID-19 vaccination series, defined as previous receipt of one of the following options:
• Doses of original monovalent mRNA or bivalent mRNA vaccine or a combination of the two,
• Doses of original monovalent Novavax COVID-19 Vaccine, alone or in combination with any mRNA vaccine doses; or
• Doses of Janssen COVID-19 Vaccine, alone or in combination with any mRNA or Original monovalent Novavax vaccine doses.
• Receipt of an FDA licensed/authorized COVID-19 vaccine within the previous 14 days or on the day of enrollment

You may not qualify if…

• Receipt or planned receipt of any of the following vaccines, on the same day or within 28 days prior to or after receipt of the FDA licensed/authorized COVID-19 vaccine:
• Shingrix (Zoster Vaccine Recombinant, Adjuvanted)
• Receipt of COVID-19 vaccine within 120 days prior to current vaccine
• Any disease or medical condition that, in the opinion of the Investigator or appropriate sub-investigator, is a contraindication to study participation
• Pregnant individuals (only exclusionary for the peripheral blood mononuclear cells [PBMCs] blood draws portion of the study)
• Currently participating or plans to participate in another clinical trial that is interventional and/or involving an investigational product.
• Are assessed by the Investigator as unsuitable for participation in this study for any reason.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.