COVID - 19NCT06761612

Retail COVID-19 Study

An observational study of COVID - 19, run by Biomedical Advanced Research and Development Authority at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 3 years and olderHealthy volunteers can take part
Conditions the study is for: COVID - 19
What is being tested?: FDA approved mRNA vaccines
Type of treatment: Vaccines
How many people: 2,519 participants
Where: 20 sitesUnited States
Study dates: 19 Oct 2024to 14 May 2026
How long will I take part?: 1 Year
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 3 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Study population: Prior to enrollment in this study, participants will receive a federally licensed and authorized vaccine, manufactured by Pfizer-BioNTech or Moderna, for the prevention of COVID-19. Each participant will complete a pre-screener questionnaire which will collect information to confirm the participant's eligibility. Upon passing the pre-screener, the participant will complete their electronic consent form and will be enrolled in the study within 72 hours of their vaccination with blood collected to establish baseline for humoral immune marker. A subset of total enrollment, a cohort of 80 participants, will also enroll in the PBMC cohort; participants in the PBMC cohort will enroll in the study within 24 hours of their vaccination with blood collected to establish baseline immune marker levels.

Who may be able to join

People ≥3 years of age at time of enrollment.
Willing and able to provide informed consent, or assent in pediatric population, if appropriate, prior to initiation of study procedures.
Able to understand and comply with planned study procedures.
Available for all study data collection points.
Receipt of the most recent FDA-licensed and authorized COVID-19 vaccine (i.e., the 2024-2025 Moderna COVID-19 vaccine or the 2024-2025 Pfizer-BioNTech COVID-19 vaccine which includes the KP.2 strain of the JN.1-lineage vaccine), as recommended by the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) and outlined in the FDA's updated guidance, administered within 3 days of enrollment.
PBMC cohort only:
People ages ≥18 years at time of enrollment. Available for first blood sample collection within 1 day of vaccine.

Who cannot join

Currently participating or plans to participate in another clinical trial involving an investigational product before completing this study.
Planned to receive another COVID-19 vaccine within 180 days.
Receipt of COVID-19 vaccination within 180 days prior to current vaccination.
Receipt of Shingrix vaccine in the 28 days prior to the COVID-19 vaccination or planned receipt of Shingrix vaccine within 28 days after receipt of COVID-19 vaccination.
Self-report of recently confirmed COVID-19 infection within 30 days.
Any disease or medical condition that, in the opinion of the principal investigator or sub-investigator, is a contraindication to study participation.
PBMC cohort only:
Confirmed positive urine pregnancy test at study visits per Schedule of Activities.

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Walgreens - 3218 Atlantic Ave
Atlantic City, New Jersey, 08401
Walgreens - 1554 E 55th St
Chicago, Illinois, 60615
Walgreens - 4385 S Archer Ave
Chicago, Illinois, 60632
Walgreens - 420 N Frazier St
Conroe, Texas, 77301
Walgreens - 1919 W Gray St
Houston, Texas, 77019
Walgreens - 7440 FM 1960 Rd E
Humble, Texas, 77346
Walgreens - 17811 E US Highway 24
Independence, Missouri, 64056
Walgreens - 3845 Broadway Blvd
Kansas City, Missouri, 64111
Walgreens - 2630 NE Vivion
Kansas City, Missouri, 64119
Walgreens - 3298 S John Young Pkwy
Kissimmee, Florida, 34746
Walgreens - 6401 W Charleston Blvd
Las Vegas, Nevada, 89146
Walgreens - 15100 W 87th Street Pkwy
Lenexa, Kansas, 66219
Walgreens - 215 Beach St
Malden, Massachusetts, 02148
Walgreens - 1445 W Craig Rd
North Las Vegas, Nevada, 89032
Walgreens - 811 Madison St
Oak Park, Illinois, 60302
Walgreens - 7500 Metcalf Ave
Overland Park, Kansas, 66204
Walgreens - 8430 Broadway St
Pearland, Texas, 77584
Walgreens - 520 Convery Blvd
Perth Amboy, New Jersey, 08861
Walgreens - 7251 Lake St
River Forest, Illinois, 60305
Walgreens - 3316 Avenue H
Rosenberg, Texas, 77471

Other trials in United States

About this study

Official title: A Longitudinal Assessment of Serology and Effectiveness to Determine COVID-19 Vaccine Correlates of Risk (CoR) and Correlates of Protection (CoP) in a Heterogeneous US Population Through Use of Decentralized Sites and Approaches for Data/Specimen Collection

Despite the availability of vaccines, there remains a need to identify specific immune responses that correlate with protection against SARS-CoV-2 infection. Additionally, the operational capability of retail pharmacy infrastructure to collect longitudinal data and biological samples needs to be assessed. This study aims to fill these gaps by determining correlates of protection (CoP), assessing the infrastructure's capability, and examining demographic and geographic differences in participation.

Read the detailed description

This multi-center study will utilize a prospective, longitudinal observational design to assess CoR and CoP for COVID-19 vaccinations. Prior to enrollment in this study, participants will receive a federally licensed and authorized vaccine, manufactured by Pfizer-BioNTech or Moderna, for the prevention of COVID-19. Each participant will complete a pre-screener questionnaire which will collect information to confirm the participant's eligibility. Upon passing the pre-screener, the participant will complete their electronic consent form and will be enrolled in the study within 72 hours of their vaccination with blood collected to establish baseline for humoral immune marker. A subset of total enrollment, a cohort of 80 participants, will also enroll in the PBMC cohort; participants in the PBMC cohort will enroll in the study within 24 hours of their vaccination with blood collected to establish baseline immune marker levels.

During this study, participants will complete five (5) visits on site (Day 01, Day 31, Day 91, Day 181, Day 366), which will involve data collection and a blood draw. Participants enrolled in the PBMC cohort will have an additional blood draw at Day 01, Day 31, Day 181, and Day 366.

All study participants will complete a weekly electronic patient reported outcome (ePRO) to report symptoms of COVID-19, and to report if they have been exposed to anyone who has tested positive for COVID-19.

Participants will be asked to report to the clinic for a nasal swab test (via molecular assay) when: participant has at least one symptom with or without a fever, and/or if the participant has recent exposure or close contact to another person with COVID-19.

This study aims to enroll at least 90 COVID-19 endpoint cases, based on an annual incidence rate of 2.5%.

Conditions: COVID - 19
Being tested: FDA approved mRNA vaccines
Keywords: Covid-19, Vaccines, Correlates of Protective Immunity, Retail Pharmacy, Walgreens, Observational
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FDA approved mRNA vaccinesBiological
This study is non-interventional as participants will have received an FDA approved mRNA COVID-19 vaccine prior to entering the study. The study protocol does not determine or allocate receipt of vaccine

Study groups in NCT06761612
Study group	Role	What they receive
Primary Cohort		Cohort Provides blood draws during on-study visits Receives: Biological: FDA approved mRNA vaccines
PBMC Cohort		Up to 80 participants providing PBMCs Receives: Biological: FDA approved mRNA vaccines

What is being measured

The primary outcome is the main question the study is designed to answer.

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);
Correlates of Protective Immunity
Measured: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
Valid Viable specimens for SARS-CoV-2 testing
Number of viable specimens collected at retail pharmacies or retail clinics over the Day 366 follow-up period that meet quality standards required for laboratory analysis.
Measured: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5).
Number of viable specimens for laboratory analysis
Viable specimens collected at retail pharmacies or retail clinics that meet quality standards required for laboratory analysis.
Measured: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
Number of valid specimens for CoP testing
Valid specimens collected at retail pharmacies or retail clinics that meet quality standards required for CoP testing.
Measured: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)

Secondary outcomes (4)

Representativeness of number of self-collected nasal swabs and blood specimens
Number of self-collected nasal swabs and blood specimens received over the Day 366 follow-up period overall and stratified by participant demographic and social determinants of health.
Measured: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5). Various
Representativeness of Number of valid COVID-19 tests
COVID-19 resulting in a positive or negative result for SARS-CoV-2 infection overall and stratified by participant demographic and social determinants of health.
Measured: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
Assessment of participant recruitment speed
Participant recruitment speed measured as time of vaccination to time of enrollment, overall and by site, as well as time to full enrollment overall and stratified by age.
Measured: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
Assessment of participant retention
Participant retention over study period (from Day 1 through Day 366 follow-up) overall and stratified by age.
Measured: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Oct 202414 May 2026

First posted7 Jan 2025
Study start19 Oct 2024
Primary completion14 May 2026
Study completion14 May 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: Cohort
Time perspective: Prospective
Enrolment: 2,519 participants (actual)
Target duration: 1 Year

IDs, dates and publications

ClinicalTrials.gov ID: NCT06761612
Sponsor's protocol ID: RRPV-24-02-Retail-009
Status last verified: May 2026
First submitted: 5 Dec 2024
Last updated: 22 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
SARS-CoV-2
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Active, not recruiting
Motivational Interviewing Intervention for Families With Overweight and Obesity
Obesity & Overweight
Active, not recruiting
Lupus Education Alliance Program
Systemic Lupus Erythematosus, COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome

All COVID - 19 trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Longitudinal Assessment of Serology and Effectiveness to Determine COVID-19 Vaccine Correlates of Risk (CoR) and Correlates of Protection (CoP) in a Heterogeneous US Population Through Use of Decentralized Sites and Approaches for Data/Specimen Collection
ClinicalTrials.gov ID: NCT06761612
Acronym / sponsor ID: RRPV-24-02-Retail-009
Conditions: COVID - 19
Keywords: Covid-19, Vaccines, Correlates of Protective Immunity, Retail Pharmacy, Walgreens, Observational
Study type: Observational
Recruitment status: Completed
Enrolment: 2,519 participants (actual)
Lead sponsor: Biomedical Advanced Research and Development AuthorityUS federal agency
Study start: 19 Oct 2024 (actual)
Primary completion: 14 May 2026 (actual)
Study completion: 14 May 2026 (actual)
First posted: 7 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.

Detailed description

This study aims to enroll at least 90 COVID-19 endpoint cases, based on an annual incidence rate of 2.5%.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 1 Year
Number of arms: 2

Arm	Type	Receives
Primary Cohort	–	Biological: FDA approved mRNA vaccinesCohort Provides blood draws during on-study visits
PBMC Cohort	–	Biological: FDA approved mRNA vaccinesUp to 80 participants providing PBMCs

Who may qualify

Ages: 3 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: Prior to enrollment in this study, participants will receive a federally licensed and authorized vaccine, manufactured by Pfizer-BioNTech or Moderna, for the prevention of COVID-19. Each participant will complete a pre-screener questionnaire which will collect information to confirm the participant's eligibility. Upon passing the pre-screener, the participant will complete their electronic consent form and will be enrolled in the study within 72 hours of their vaccination with blood collected to establish baseline for humoral immune marker. A subset of total enrollment, a cohort of 80 participants, will also enroll in the PBMC cohort; participants in the PBMC cohort will enroll in the study within 24 hours of their vaccination with blood collected to establish baseline immune marker levels.

Key inclusion criteria (7 listed)

People ≥3 years of age at time of enrollment.
Willing and able to provide informed consent, or assent in pediatric population, if appropriate, prior to initiation of study procedures.
Able to understand and comply with planned study procedures.
Available for all study data collection points.
Receipt of the most recent FDA-licensed and authorized COVID-19 vaccine (i.e., the 2024-2025 Moderna COVID-19 vaccine or the 2024-2025 Pfizer-BioNTech COVID-19 vaccine which includes the KP.2 strain of the JN.1-lineage vaccine), as recommended by the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) and outlined in the FDA's updated guidance, administered within 3 days of enrollment.

Key exclusion criteria (8 listed)

Currently participating or plans to participate in another clinical trial involving an investigational product before completing this study.
Planned to receive another COVID-19 vaccine within 180 days.
Receipt of COVID-19 vaccination within 180 days prior to current vaccination.
Receipt of Shingrix vaccine in the 28 days prior to the COVID-19 vaccination or planned receipt of Shingrix vaccine within 28 days after receipt of COVID-19 vaccination.
Self-report of recently confirmed COVID-19 infection within 30 days.

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
FDA approved mRNA vaccinesThis study is non-interventional as participants will have received an FDA approved mRNA COVID-19 vaccine prior to entering the study. The study protocol does not determine or allocate receipt of vaccine	Biological	PBMC Cohort, Primary Cohort

Primary outcome

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);
Time frame: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
Correlates of Protective Immunity
Valid Viable specimens for SARS-CoV-2 testing
Time frame: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5).
Number of viable specimens collected at retail pharmacies or retail clinics over the Day 366 follow-up period that meet quality standards required for laboratory analysis.
Number of viable specimens for laboratory analysis
Time frame: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
Viable specimens collected at retail pharmacies or retail clinics that meet quality standards required for laboratory analysis.
Number of valid specimens for CoP testing
Time frame: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
Valid specimens collected at retail pharmacies or retail clinics that meet quality standards required for CoP testing.

4 secondary outcomes

Representativeness of number of self-collected nasal swabs and blood specimens
Time frame: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5). Various
Representativeness of Number of valid COVID-19 tests
Time frame: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
Assessment of participant recruitment speed
Time frame: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
Assessment of participant retention
Time frame: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)

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 22 May 2026.
Retail COVID-19 Study WebsiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes

Related trials for COVID - 19

RecruitingPhase 3
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
SARS-CoV-2
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Active, not recruiting
Motivational Interviewing Intervention for Families With Overweight and Obesity
Obesity & Overweight
Active, not recruiting
Lupus Education Alliance Program
Systemic Lupus Erythematosus, COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome

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.

20 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 20 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 7 inclusion and 8 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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?

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); (time frame: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06761612.

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 22 May 2026.