Project REMOTE (REimagining Measurements and Operations of Translational Endpoints)

Overview

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.

This is a non-interventional, minimal-risk, observational study to determine correlates of an FDA-authorized/approved COVID-19 vaccine in a heterogeneous US population. Most participants will be remotely consented, screened, enrolled, and randomized outside of a physical clinical research site. Participants will be screened for study participation from Days -14 to -1 either remotely or at a clinical research site. After screening, eligible participants will be enrolled and will be randomized to one of two groups. Participants randomized to Group A (n\~200) will be evaluated at a traditional clinical research site to include site visits for venous blood and saliva specimens to be collected by appropriately trained site personnel within 7 days of enrollment and again at approximately Months 1, 3, 6 and 12. Participants randomized to Group B (n\~3800) will undergo fully remote evaluation to include self-collection of capillary blood and saliva specimens occurring within 7 days of enrollment, after receipt of the self-collection sample kits/wearable device. Self-collection will be aided by the electronic Clinical Outcome Assessment (eCOA) platform and/or virtual telehealth visits with the site staff and will occur within 7 days of enrollment and approximately at Months 1, 3, 6, and 12 to mirror group A visits. Though not part of the study, participants will be required to obtain a currently FDA-approved or -authorized COVID-19 vaccine as part of the inclusion criteria. Participants will be followed for 12 months from receipt of vaccination. Both groups will be surveilled with weekly queries for COVID-19 like symptoms for the duration of the study using an eCOA application on the participant's tablet or smartphone. Should Group A participants identify the presence of COVID-19 like symptoms they will be prompted to schedule an acute visit with their respective site where site staff will collect a nasal swab for PCR to confirm COVID-19 disease. Should Group B participants identify the presence of COVID-19 like symptoms they will be prompted to schedule an acute telehealth visit with their respective site and then self-collect a nasal swab for PCR to confirm COVID-19.