Project REMOTE (REimagining Measurements and Operations of Translational Endpoints) (REMOTE)

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19
• Intervention / Treatment: Other: Traditional clinical trial participation with clinician-collected specimens; Other: Remote study participation and self-collection of specimens

Detailed 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 (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.

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Vestavia Hills, Alabama, United States, 35216
      • Accel Research Site Networks - Birmingham CRU / Elite
  • Arizona
    • Mesa, Arizona, United States, 85213
      • Desert Clinical Research
  • California
    • Fair Oaks, California, United States, 95628
      • Apex Research Group
    • Los Angeles, California, United States, 91316
      • Wake Research Encino
    • San Diego, California, United States, 92111
      • Wake Research San Diego
  • Florida
    • Miami, Florida, United States, 33173
      • Research Institute of South Florida
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Atlanta, Georgia, United States, 30328
      • Wake Research Atlanta
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Johnson County Clinical Trials (JCCT)
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Research Integrity / WCG
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Alcanza / hyperCORE
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Be Well Clinical Studies / Elite
  • New York
    • Syracuse, New York, United States, 13057
      • SUNY / Upstate Medical University Global Health Institute
  • Ohio
    • Blue Ash, Ohio, United States, 45242
      • Kroger The Little Clinic (Remote Site)
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute East / Elite
  • Texas
    • Dallas, Texas, United States, 75246
      • Wake Research Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Study population: approximately 4,000 individuals in the US with the following considerations:

• Target 25% of participants ≥65 years of age
• Appropriate representation of participants at high risk for severe COVID-19
• Appropriate representation of racially and ethnically diverse populations

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; In-clinic study visits and clinic-collected specimens	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.
Group B; Fully remote evaluation and self-collected specimens	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine correlates of risk and protection of an FDA-authorized/approved COVID-19 vaccine in a heterogeneous US population using self-collected specimens (Group B only)	Serum S protein-specific binding antibody (bAb) concentrations (peak and exposure-proximal assessments); Serum SARS-CoV-2 specific neutralizing antibody (nAb) titers (peak and exposure-proximal assessments); COVID-19: Virologically confirmed SARS-CoV-2 infection (by qualitative reverse transcriptase polymer chain reaction [PCR]), along with one or more of the following: fever, chills, cough, headache, fatigue, diarrhea, new loss of taste or smell, sore throat, congestion, runny nose, nausea or vomiting, shortness of breath or difficulty breathing, or muscle or body ache	From Enrollment through Day 366

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine correlates of risk and protection of an FDA-authorized/approved COVID-19 vaccine in a heterogeneous US population (across Groups A and B)	Serum S protein-specific binding antibody (bAb) concentrations (peak and exposure-proximal assessments); Serum SARS-CoV-2 specific neutralizing (nAb) antibody titers (peak and exposure-proximal assessments); COVID-19: Virologically confirmed SARS-CoV-2 infection (by qualitative reverse transcriptase polymer chain reaction [PCR]), along with one or more of the following: fever, chills, cough, headache, fatigue, diarrhea, new loss of taste or smell, sore throat, congestion, runny nose, nausea or vomiting, shortness of breath or difficulty breathing, or muscle or body ache.	From Enrollment through Day 366
Determine correlates of risk and protection of an FDA-authorized/approved COVID-19 vaccine against severe disease in a heterogeneous US population (Group B only)	Serum S protein-specific bAb concentrations (peak and exposure-proximal assessments); Serum SARS-CoV-2 specific nAb titers (peak and exposure-proximal assessments); COVID-19 per Primary Objective Endpoint definition, plus any one or more of the following: clinical signs indicative of severe systemic illness, respiratory Rate ≥ 30 per minute, heart rate ≥ 125 beats per minute, SpO2 ≤ 93% on room air at sea level or PaO2/FIO2 < 300 mm Hg, respiratory failure or Acute Respiratory Distress Syndrome (ARDS)1, evidence of shock2, significant acute renal, hepatic, or neurologic dysfunction, admission to an intensive care unit or death	From Enrollment through Day 366
Assess the feasibility of gathering valid remote self-collected specimens (across Groups A and B)	Number of self-collected nasal swabs, saliva specimens, and capillary blood specimens received vs expected; Comparison of proportion of valid specimens among self-collected capillary blood specimens to clinical-site venous specimens; Acceptability and tolerance of specimen collection methods	From Enrollment through Day 366
Assess safety of an FDA authorized/approved COVID-19 vaccine (across Groups A and B)	Serious adverse events (SAEs) through 6 months following vaccination	From Enrollment through Day 181

Collaborators and Investigators

• Sponsor: Biomedical Advanced Research and Development Authority
• Collaborators: Fred Hutchinson Cancer Center; Allucent

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): January 15, 2025

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: COVID-19; feasibility; COVID-19 vaccine; self-collected; Pandemic Preparedness; immune correlates
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: BP-24-001; 75A50123D00005. (Other Grant/Funding Number: Barda)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No