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Project REMOTE (REimagining Measurements and Operations of Translational Endpoints)

NCT06776367 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 4000

Last updated 2025-09-17

No results posted yet for this study

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.

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.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-20
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06776367 on ClinicalTrials.gov