COVID-19 VaccinationCoVAcSNCT05027464
Developing and Testing a COVID-19 Vaccination Acceptance Intervention
A study testing Moving to COVID-19 Vaccine Acceptance Intervention in people with COVID-19 Vaccination, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
The COVID-19 pandemic has resulted in significant loss of life and suffering with total case and death counts increasing daily, particularly with the emergence of the delta variant. COVID-19 vaccines have proven highly effective in preventing severe illness, hospitalization, and death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Vaccination
- What is being tested?
- Moving to COVID-19 Vaccine Acceptance Intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338,718 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Apr 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aim 1: Primary care clinic visit in VISN 16 or 21
- Aim 2: =1 visit(s) at a participating VISN 16 or 21 primary care clinic or CBOC after the start of the trial at their site, and at the time of recruitment, COVID-19 vaccination status is verified as one of the following:
- has not initiated COVID-19 vaccination
- has initiated one of the two mRNA vaccines and is outside the window for the second dose
- recently completed COVID-19 vaccination (has completed two doses of mRNA vaccination or has completed the single-dose Janssen/Johnson \& Johnson vaccine within the past 60 days)
- Aim 3: Implementation-focused Interviews with VISN 16 and 21 Staff and HCPs
Who cannot join
- Aim 1: Per VISN or VAMC leadership, the clinic or CBOC has extreme staffing shortages such that it would not be feasible or in the best interests of patient care to allow clinic or CBOC staff release time to participate in trainings or other meetings related to the trial
- Aim 2: Has initiated COVID-19 vaccination with one of the mRNA vaccines and is within the window to complete the second dose on schedule (< 42 days since dose 1)
- Serious allergic reaction or other contraindication to COVID-19 vaccination or other vaccines (e.g., flu vaccine)
- Currently in hospice care or < 6 months to live
- No consistent ability to be contacted by phone
- Participating in another COVID-19 trial or study (research study flag)
Show all 9Show fewer
- Moderate to severe dementia as documented in the patient's VA medical record
- Increased suicide risk as indicated by behavioral health flag
- Aim 3: Staff or HCPs declines invitation to participate in the interview
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
North Little Rock, Arkansas, 72114-1706
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563
About this study
The COVID-19 pandemic has resulted in significant loss of life and suffering with total case and death counts increasing daily, particularly with the emergence of the delta variant. COVID-19 vaccines have proven highly effective in preventing severe illness, hospitalization, and death. Nevertheless, according to VA data sources, only 56% of all U.S. Veterans have been vaccinated to date, largely owing to vaccine hesitancy and lack of access to vaccination. Thus, there is a critical need for evidence-based interventions to increase COVID-19 vaccine acceptance and access among Veterans, many of whom are vulnerable to poor outcomes of COVID-19. The overall goal of this study is to increase COVID-19 vaccination in Veterans of VISNs 16 and 21 who remain unvaccinated either because of vaccine hesitancy or lack of access to COVID-19 vaccine. Specifically, the investigators will test a COVID-19 Vaccine Acceptance Intervention (Motivational Interviewing) plus Implementation Facilitation.
Read the detailed description
For Aim 1, the investigators will conduct a one-year cluster randomized controlled trial of a Vaccine Acceptance Intervention versus Usual Care with randomization at the level of VA Medical Center (VAMC). Usual Care will consist of all national and local initiatives to promote COVID-19 vaccine acceptance in Veterans such as vaccine mandates, mobile clinics, outreach calls, etc. The Implementation Facilitation team will include a VISN-level external facilitator, VAMC-level internal facilitators, and clinic-level site champions to support PACT staff, Coaches and Peers in implementing the Vaccine Acceptance Intervention with unvaccinated Veterans as well as in lowering barriers to vaccine access at intervention sites. For Aim 2, the investigators will identify a diverse sample of 450 Veterans across VAMCs in VISNs 16 and 21, who have had primary care visits at Intervention and Usual Care sites, and who have either recently received (N=360) or have not received (N=90) COVID-19 vaccination. The investigators will over sample recently vaccinated Veterans to describe the impact of the Vaccine Acceptance Intervention on Veterans' decisions to accept COVID-19 vaccination in addition to over-sampling women, ethnic/racial minorities, rural and younger Veterans, and those with mental health conditions. Follow-up qualitative interviews will be conducted in a subsample to better understand factors related to recent vaccine acceptance and persistent vaccine hesitancy. Finally, for Aim 3, the investigators will conduct process and summative interviews with VA staff and providers from VAMC sites in VISNs 16 and 21 with high and low vaccination rates) to learn which implementation strategies were most and least effective.
- Conditions
- COVID-19 Vaccination
- Being tested
- Moving to COVID-19 Vaccine Acceptance Intervention
- Keywords
- COVID-19 Vaccine, Motivational Interviewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moving to COVID-19 Vaccine Acceptance InterventionBehavioural
The intervention utilizes a multi-pronged approach to increase Veteran vaccine acceptance. First, the research team will train Health Behavior Coordinators (HBCs) at VAI sites. HBCs will then train PACT teams at their site and Whole Health Coaches, Peer Specialists and other VA Staff in VAI strategies to use with unvaccinated Veterans. Whole Health Coaches, Peer Specialists and other VA Staff will conduct outreach calls, using strategies, with unvaccinated Veterans.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | The VAMC Internal Facilitator will partner with the trial External Facilitators (research team and designated External Facilitators in VISNS 16 and 21) to adapt and implement the study intervention to best meet the needs and preferences of their VAMC site. In addition, each CBOC and clinic affiliated with a VAMC in the Intervention arm will need to identify a Site Champion to provide clinic-specific information to facilitate implementation of the Vaccine Acceptance Intervention at their clinic or CBOC. In addition, for clinics and CBOCs assigned to the Vaccine Acceptance Intervention, VAMC, clinic and CBOC leadership will need to agree to release PACT staff for an initial two-hour Motivational Interviewing (MI) training, and at least one 60-minute post-training consultation session over the one-year trial period. There will be additional consultation sessions offered to intervention clinics and CBOC staff, but these will be optional. Receives: Behavioral: Moving to COVID-19 Vaccine Acceptance Intervention |
| Usual Care Arm | No intervention | A VAMC assigned to Usual Care will have no specific trial intervention requirements beyond their usual level of participation in national and local initiatives to improve COVID-19 vaccine acceptance. At both Intervention and Usual Care sites, the study team will perform quarterly "environmental scans". The environmental scan survey will include questions about site specific barriers to COVID-19 vaccination (first dose and second dose if needed), current programs/initiatives in the clinic or local community that are improving or have had no impact on vaccination rates, and the perceived importance that the VAMC/CBOC clinic staff is placing on vaccination (Environmental Scan Survey, in preparation). At Usual Care sites, a point of contact will be chosen from each clinic and CBOC to complete the environmental scan, and at Intervention sites, the Site Champion (see below) will perform the quarterly scan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of Any Dose COVID-19 Vaccination
A greater proportion of Veterans in the intervention group will receive any dose of COVID-19 vaccination compared to usual care.
Measured: 1 year
Secondary outcomes (1)
Primary Series Completion of COVID-19 Vaccination
A greater proportion of previously unvaccinated Veterans in the intervention arm will complete the primary series for COVID-19 vaccination compared to usual care
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start5 Apr 2022
- Primary completion30 Aug 2023
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19 VaccinationStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One-year cluster randomized parallel group trial, stratified by VISN, using covariate constrained randomization (e.g., rural/urban clinics, facility size). Specifically, the investigators will compare a Vaccine Acceptance Intervention versus Usual Care with randomization at the level of VA Medical Center (VAMC), with the intervention directed at VAMC clinic and CBOC PACT staff members.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 338,718 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Edith Nourse Rogers Memorial Veterans Hospital, Central Arkansas Veterans Healthcare System, Minneapolis Veterans Affairs Medical Center
- Responsible party
- Sponsor
- Investigators
- Karen H Seal, MD MPH, Principal investigator, San Francisco VA Medical Center, San Francisco, CAJeffrey M Pyne, MD, Principal investigator, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, ARJennifer K Manuel, PhD, Principal investigator, San Francisco VA Medical Center, San Francisco, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027464
- Sponsor's protocol ID
- SDR 21-141
- Acronym
- CoVAcS
- Status last verified
- Nov 2024
- First submitted
- 26 Aug 2021
- Last updated
- 8 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pyne JM, Seal KH, Manuel JK, DeRonne B, Oliver KA, Bertenthal D, Esserman D, Purcell N, Petrakis BA, Elwy AR. Developing and testing a COVID-19 vaccination acceptance intervention: A pragmatic trial comparing vaccine acceptance intervention vs usual care - Rationale, methods, and implementation. Contemp Clin Trials. 2023 Oct;133:107325. doi: 10.1016/j.cct.2023.107325. Epub 2023 Aug 29.
PubMed 37652356Seal KH, Bertenthal D, Manuel JK, Pyne JM. Association of Demographic, Clinical, and Social Determinants of Health With COVID-19 Vaccination Booster Dose Completion Among US Veterans. JAMA Netw Open. 2022 Jul 1;5(7):e2222635. doi: 10.1001/jamanetworkopen.2022.22635.
PubMed 35852805Seal KH, Kaplan A, Manuel JK, Bertenthal D, Purcell N, DeRonne BM, Oliver KA, Esserman D, McCamish N, Mesidor M, Griffin B, Borsari B, Woodruff NA, Usman H, Pyne JM. A Cluster Randomized Trial of a Vaccination Communication Educational Intervention: Impact on COVID-19 Vaccine Uptake in Veterans. J Gen Intern Med. 2026 Jun;41(8):2217-2226. doi: 10.1007/s11606-026-10209-9. Epub 2026 Feb 12.
PubMed 41680545Pyne JM, Seal KH, Manuel JK, Kaplan AN, Purcell N, Bertenthal D, Esserman D, Mesidor M, DeRonne BM, Oliver KA, Griffin BJ, Simpson H, Woodruff N, Borsari B, Tobey-Moore L, Usman H. Factors contributing to COVID-19 vaccine hesitancy in Veterans later in the pandemic. BMC Public Health. 2025 Dec 19;26(1):295. doi: 10.1186/s12889-025-25716-3.
PubMed 41413473
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing a COVID-19 Vaccination Acceptance Intervention
- ClinicalTrials.gov ID
- NCT05027464
- Acronym / sponsor ID
- CoVAcS / SDR 21-141
- Conditions
- COVID-19 Vaccination
- Keywords
- COVID-19 Vaccine, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338,718 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Edith Nourse Rogers Memorial Veterans Hospital, Central Arkansas Veterans Healthcare System, Minneapolis Veterans Affairs Medical Center
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Posted 8 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The COVID-19 pandemic has resulted in significant loss of life and suffering with total case and death counts increasing daily, particularly with the emergence of the delta variant. COVID-19 vaccines have proven highly effective in preventing severe illness, hospitalization, and death. Nevertheless, according to VA data sources, only 56% of all U.S. Veterans have been vaccinated to date, largely owing to vaccine hesitancy and lack of access to vaccination. Thus, there is a critical need for evidence-based interventions to increase COVID-19 vaccine acceptance and access among Veterans, many of whom are vulnerable to poor outcomes of COVID-19. The overall goal of this study is to increase COVID-19 vaccination in Veterans of VISNs 16 and 21 who remain unvaccinated either because of vaccine hesitancy or lack of access to COVID-19 vaccine. Specifically, the investigators will test a COVID-19 Vaccine Acceptance Intervention (Motivational Interviewing) plus Implementation Facilitation.
Detailed description
For Aim 1, the investigators will conduct a one-year cluster randomized controlled trial of a Vaccine Acceptance Intervention versus Usual Care with randomization at the level of VA Medical Center (VAMC). Usual Care will consist of all national and local initiatives to promote COVID-19 vaccine acceptance in Veterans such as vaccine mandates, mobile clinics, outreach calls, etc. The Implementation Facilitation team will include a VISN-level external facilitator, VAMC-level internal facilitators, and clinic-level site champions to support PACT staff, Coaches and Peers in implementing the Vaccine Acceptance Intervention with unvaccinated Veterans as well as in lowering barriers to vaccine access at intervention sites. For Aim 2, the investigators will identify a diverse sample of 450 Veterans across VAMCs in VISNs 16 and 21, who have had primary care visits at Intervention and Usual Care sites, and who have either recently received (N=360) or have not received (N=90) COVID-19 vaccination. The investigators will over sample recently vaccinated Veterans to describe the impact of the Vaccine Acceptance Intervention on Veterans' decisions to accept COVID-19 vaccination in addition to over-sampling women, ethnic/racial minorities, rural and younger Veterans, and those with mental health conditions. Follow-up qualitative interviews will be conducted in a subsample to better understand factors related to recent vaccine acceptance and persistent vaccine hesitancy. Finally, for Aim 3, the investigators will conduct process and summative interviews with VA staff and providers from VAMC sites in VISNs 16 and 21 with high and low vaccination rates) to learn which implementation strategies were most and least effective.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- One-year cluster randomized parallel group trial, stratified by VISN, using covariate constrained randomization (e.g., rural/urban clinics, facility size). Specifically, the investigators will compare a Vaccine Acceptance Intervention versus Usual Care with randomization at the level of VA Medical Center (VAMC), with the intervention directed at VAMC clinic and CBOC PACT staff members.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Moving to COVID-19 Vaccine Acceptance InterventionThe VAMC Internal Facilitator will partner with the trial External Facilitators (research team and designated External Facilitators in VISNS 16 and 21) to adapt and implement the study intervention to best meet the needs and preferences of their VAMC site. In addition, each CBOC and clinic affiliated with a VAMC in the Intervention arm will need to identify a Site Champion to provide clinic-specific information to facilitate implementation of the Vaccine Acceptance Intervention at their clinic or CBOC. In addition, for clinics and CBOCs assigned to the Vaccine Acceptance Intervention, VAMC, clinic and CBOC leadership will need to agree to release PACT staff for an initial two-hour Motivational Interviewing (MI) training, and at least one 60-minute post-training consultation session over the one-year trial period. There will be additional consultation sessions offered to intervention clinics and CBOC staff, but these will be optional. |
| Usual Care Arm | No intervention | –A VAMC assigned to Usual Care will have no specific trial intervention requirements beyond their usual level of participation in national and local initiatives to improve COVID-19 vaccine acceptance. At both Intervention and Usual Care sites, the study team will perform quarterly "environmental scans". The environmental scan survey will include questions about site specific barriers to COVID-19 vaccination (first dose and second dose if needed), current programs/initiatives in the clinic or local community that are improving or have had no impact on vaccination rates, and the perceived importance that the VAMC/CBOC clinic staff is placing on vaccination (Environmental Scan Survey, in preparation). At Usual Care sites, a point of contact will be chosen from each clinic and CBOC to complete the environmental scan, and at Intervention sites, the Site Champion (see below) will perform the quarterly scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aim 1: Primary care clinic visit in VISN 16 or 21
- Aim 2: =1 visit(s) at a participating VISN 16 or 21 primary care clinic or CBOC after the start of the trial at their site, and at the time of recruitment, COVID-19 vaccination status is verified as one of the following:
- Aim 3: Implementation-focused Interviews with VISN 16 and 21 Staff and HCPs
Key exclusion criteria (9 listed)
- Aim 1: Per VISN or VAMC leadership, the clinic or CBOC has extreme staffing shortages such that it would not be feasible or in the best interests of patient care to allow clinic or CBOC staff release time to participate in trainings or other meetings related to the trial
- Aim 2: Has initiated COVID-19 vaccination with one of the mRNA vaccines and is within the window to complete the second dose on schedule (< 42 days since dose 1)
- Aim 3: Staff or HCPs declines invitation to participate in the interview
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 |
|---|---|---|
| Moving to COVID-19 Vaccine Acceptance InterventionThe intervention utilizes a multi-pronged approach to increase Veteran vaccine acceptance. First, the research team will train Health Behavior Coordinators (HBCs) at VAI sites. HBCs will then train PACT teams at their site and Whole Health Coaches, Peer Specialists and other VA Staff in VAI strategies to use with unvaccinated Veterans. Whole Health Coaches, Peer Specialists and other VA Staff will conduct outreach calls, using strategies, with unvaccinated Veterans. | Behavioural | Intervention Arm |
Primary outcome
Receipt of Any Dose COVID-19 Vaccination
Time frame: 1 year
A greater proportion of Veterans in the intervention group will receive any dose of COVID-19 vaccination compared to usual care.
1 secondary outcome
Primary Series Completion of COVID-19 Vaccination
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37652356Pyne JM, Seal KH, Manuel JK, DeRonne B, Oliver KA, Bertenthal D, Esserman D, Purcell N, Petrakis BA, Elwy AR. Developing and testing a COVID-19 vaccination acceptance intervention: A pragmatic trial comparing vaccine acceptance intervention vs usual care - Rationale, methods, and implementation. Contemp Clin Trials. 2023 Oct;133:107325. doi: 10.1016/j.cct.2023.107325. Epub 2023 Aug 29.
- Results publication: PubMed 35852805Seal KH, Bertenthal D, Manuel JK, Pyne JM. Association of Demographic, Clinical, and Social Determinants of Health With COVID-19 Vaccination Booster Dose Completion Among US Veterans. JAMA Netw Open. 2022 Jul 1;5(7):e2222635. doi: 10.1001/jamanetworkopen.2022.22635.
- Derived from this study: PubMed 41680545Seal KH, Kaplan A, Manuel JK, Bertenthal D, Purcell N, DeRonne BM, Oliver KA, Esserman D, McCamish N, Mesidor M, Griffin B, Borsari B, Woodruff NA, Usman H, Pyne JM. A Cluster Randomized Trial of a Vaccination Communication Educational Intervention: Impact on COVID-19 Vaccine Uptake in Veterans. J Gen Intern Med. 2026 Jun;41(8):2217-2226. doi: 10.1007/s11606-026-10209-9. Epub 2026 Feb 12.
- Derived from this study: PubMed 41413473Pyne JM, Seal KH, Manuel JK, Kaplan AN, Purcell N, Bertenthal D, Esserman D, Mesidor M, DeRonne BM, Oliver KA, Griffin BJ, Simpson H, Woodruff N, Borsari B, Tobey-Moore L, Usman H. Factors contributing to COVID-19 vaccine hesitancy in Veterans later in the pandemic. BMC Public Health. 2025 Dec 19;26(1):295. doi: 10.1186/s12889-025-25716-3.
- Individual participant dataSharing planned: No
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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.
Karen H Seal, MD MPH principal investigator
San Francisco VA Medical Center, San Francisco, CA
Jeffrey M Pyne, MD principal investigator
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Jennifer K Manuel, PhD principal investigator
San Francisco VA Medical Center, San Francisco, CA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moving to COVID-19 Vaccine Acceptance Intervention in people with COVID-19 Vaccination, run by VA Office of Research and Development at 2 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 6 inclusion and 9 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 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 8 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Receipt of Any Dose COVID-19 Vaccination (time frame: 1 year). 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 NCT05027464, which also lists 4 linked publications.
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 8 Nov 2024.