Project REMOTE (REimagining Measurements and Operations of Translational Endpoints)

Last updated: January 10, 2025
Sponsor: Biomedical Advanced Research and Development Authority
Overall Status: Active - Recruiting

Phase

N/A

Condition

Covid-19

Treatment

Remote study participation and self-collection of specimens

Traditional clinical trial participation with clinician-collected specimens

Clinical Study ID

NCT06776367
BP-24-001
75A50123D00005.
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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 timepoints 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Are willing and able to provide voluntary electronic informed consent (eConsent) toparticipate in the study and written authorization (via electronic signature) foruse and disclosure of protected health information

  • Are able to understand and comply with planned study procedures, including specimencollection devices, use of eCOA application on a tablet or smartphone, and thewearable 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 asprevious receipt of one of the following options:

  • Doses of original monovalent mRNA or bivalent mRNA vaccine or a combination ofthe two,

  • Doses of original monovalent Novavax COVID-19 Vaccine, alone or in combinationwith any mRNA vaccine doses; or

  • Doses of Janssen COVID-19 Vaccine, alone or in combination with any mRNA orOriginal monovalent Novavax vaccine doses.

  • Receipt of an FDA licensed/authorized COVID-19 vaccine within the previous 14 daysor on the day of enrollment

Exclusion

Exclusion Criteria:

  • Receipt or planned receipt of any of the following vaccines, on the same day orwithin 28 days prior to or after receipt of the FDA licensed/authorized COVID-19vaccine:

  • 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 orappropriate 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 isinterventional and/or involving an investigational product.

  • Are assessed by the Investigator as unsuitable for participation in this study forany reason.

Study Design

Total Participants: 4000
Treatment Group(s): 2
Primary Treatment: Remote study participation and self-collection of specimens
Phase:
Study Start date:
December 20, 2024
Estimated Completion Date:
July 31, 2026

Study Description

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 (n200) 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 (n3800) 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.

Connect with a study center

  • Apex Research Group

    Fair Oaks, California 95628
    United States

    Active - Recruiting

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