COVID-19REMOTENCT06776367
Project REMOTE (REimagining Measurements and Operations of Translational Endpoints)
An observational study of COVID-19, run by Biomedical Advanced Research and Development Authority at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Remote study participation and self-collection of specimens and Traditional clinical trial participation with clinician-collected specimens
- How many people
- 1,753 participants
- Where
- 16 sitesUnited States
- Study dates
- 20 Dec 2024to 19 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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,
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Emory University
Atlanta, Georgia, 30322
Wake Research Atlanta
Atlanta, Georgia, 30328
Kroger The Little Clinic (Remote Site)
Blue Ash, Ohio, 45242
Alcanza / hyperCORE
Boston, Massachusetts, 02131
Wake Research Dallas
Dallas, Texas, 75246
Apex Research Group
Fair Oaks, California, 95628
Johnson County Clinical Trials (JCCT)
Lenexa, Kansas, 66219
Be Well Clinical Studies / Elite
Lincoln, Nebraska, 68516
Wake Research Encino
Los Angeles, California, 91316
Desert Clinical Research
Mesa, Arizona, 85213
Research Institute of South Florida
Miami, Florida, 33173
Lynn Health Science Institute East / Elite
Oklahoma City, Oklahoma, 73112
Research Integrity / WCG
Owensboro, Kentucky, 42303
Wake Research San Diego
San Diego, California, 92111
SUNY / Upstate Medical University Global Health Institute
Syracuse, New York, 13057
Accel Research Site Networks - Birmingham CRU / Elite
Vestavia Hills, Alabama, 35216
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Remote study participation and self-collection of specimens, Traditional clinical trial participation with clinician-collected specimens
- Keywords
- COVID-19, Pandemic Preparedness, COVID-19 vaccine, immune correlates, self-collected, feasibility
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote study participation and self-collection of specimensOther
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.
Traditional clinical trial participation with clinician-collected specimensOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | In-clinic study visits and clinic-collected specimens Receives: Other: Traditional clinical trial participation with clinician-collected specimens | |
| Group B | Fully remote evaluation and self-collected specimens Receives: Other: Remote study participation and self-collection of specimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From Enrollment through Day 366
Secondary outcomes (4)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: From Enrollment through Day 181
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start20 Dec 2024
- Primary completion19 Aug 2026
- Study completion19 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,753 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomedical Advanced Research and Development Authority
- Sponsor type
- US federal agency
- Collaborators
- Fred Hutchinson Cancer Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776367
- Sponsor's protocol ID
- BP-24-001
- Other IDs
- 75A50123D00005.
- Acronym
- REMOTE
- Status last verified
- Sep 2026
- First submitted
- 10 Jan 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06776367
- Acronym / sponsor ID
- REMOTE / BP-24-001
- Conditions
- COVID-19
- Keywords
- COVID-19, Pandemic Preparedness, COVID-19 vaccine, immune correlates, self-collected, feasibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,753 participants (actual)
- Lead sponsor
- Biomedical Advanced Research and Development AuthorityUS federal agency
- Collaborators
- Fred Hutchinson Cancer Center
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 19 Aug 2026 (actual)
- Study completion
- 19 Aug 2026 (actual)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Traditional clinical trial participation with clinician-collected specimensIn-clinic study visits and clinic-collected specimens |
| Group B | – | Other: Remote study participation and self-collection of specimensFully remote evaluation and self-collected specimens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (7 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote study participation and self-collection of specimensParticipants 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 | Group B |
| Traditional clinical trial participation with clinician-collected specimensParticipants 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. | Other | Group A |
Primary outcome
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)
Time frame: From Enrollment through Day 366
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
4 secondary outcomes
Determine correlates of risk and protection of an FDA-authorized/approved COVID-19 vaccine in a heterogeneous US population (across Groups A and B)
Time frame: 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)
Time frame: From Enrollment through Day 366
Assess the feasibility of gathering valid remote self-collected specimens (across Groups A and B)
Time frame: From Enrollment through Day 366
Assess safety of an FDA authorized/approved COVID-19 vaccine (across Groups A and B)
Time frame: From Enrollment through Day 181
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Biomedical Advanced Research and Development Authority at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: From Enrollment through Day 366). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.