COVID-19C4591068NCT06703190
Estimated Vaccine Effectiveness and Durability of Pfizer/BioNTech 2024-2025 COVID-19 Vaccine
An observational study of COVID-19, run by Pfizer at 1 site in United States.
Trial summary
This study is a retrospective case control analysis on the real-world effectiveness of the Pfizer-BioNTech BNT162b2 vaccine (2024-2025 formulation) against symptomatic SARS-CoV-2 infection among CVS MinuteClinic patients testing for SARS-CoV-2, across different age groups, during periods of various variant… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Pfizer-BioNTech BNT162b2 COVID-19 Vaccinated and Not vaccinated with 2024-2025 formulated COVID-19 vaccine
- Type of treatment
- Vaccines
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2024to 6 Jun 2025
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include retrospectively gathered data from those testing for SARS-CoV-2 at a CVS MinuteClinic
Who may be able to join
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- MinuteClinic Patients (at least 5 years of age) testing for SARS-CoV-2 on or after September 5th 2024 (at least 14 days after FDA approval of the updated 2024-2025 COVID-19 vaccine formulation); AND
- At least one symptom reported on the ICATT questionnaire; AND
- No evidence of a positive SARS-CoV-2 test or COVID-19 diagnosis (or COVID-19 antiviral medications picked up at CVS) within the prior 90 days; AND
- Vaccine status reported on the ICATT questionnaire and/or ability to confirm receipt of the 2024-2025 formulated COVID-19 vaccine via CVS or Aetna records; AND
- Received Pfizer-BioNTech BNT162b2 COVID-19 vaccine (2024-2025 formulation); OR
- Did not receive any 2024-2025 formulated COVID-19 vaccine (regardless of manufacturer)
Who cannot join
- Patients meeting any of the following criteria will NOT be included in the study:
- Those testing at drive-thru locations;
- Those who tested but are without a completed ICATT questionnaire
- Those with invalid test results
- Those not reporting any symptoms
- Those who received a 2024-2025 formulated COVID-19 vaccine other than from Pfizer/BioNTech (confirmed via a combination of patient- or provider-report and validation against CVS or Aetna vaccination data).
Show all 9Show fewer
- Those who received a 2024-2025 formulated COVID-19 vaccine <14 days prior to the test date.
- Those who reported "prefer not to answer" for vaccination history (and no evidence from CVS vaccination or Aetna data that the patient had received the Pfizer/BioNTech COVID-19 vaccine [2024-2025 formulation]).
- Those who tested multiple times during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estimated Vaccine Effectiveness (VE) and Durability of Pfizer/BioNTech 2024-2025 COVID-19 (Coronavirus Disease 2019) Vaccine
This study is a retrospective case control analysis on the real-world effectiveness of the Pfizer-BioNTech BNT162b2 vaccine (2024-2025 formulation) against symptomatic SARS-CoV-2 infection among CVS MinuteClinic patients testing for SARS-CoV-2, across different age groups, during periods of various variant circulation, and by months since receipt of vaccine dose.
Read the detailed description
Background:
Omicron and its sublineages have comprised of the majority of SARS-CoV-2 genomes sequenced by the Centers for Disease Control and Prevention (CDC) since December 2021. KP.2 was first identified as a circulating variant under monitoring (VUM) by the World Health Organization in March 2024. FLiRT-mutated subvariants (including KP.2 and recent FluQE-mutated subvariants) have been the predominant variants sequenced in the US throughout 2024. FLiRT-mutated sub-lineages are antigenically distant from prior circulating SARS-CoV-2 lineages, including Omicron XBB, Omicron BA.4/BA.5 and the original SARS-CoV-2 wild-type strain. While Omicron XBB-adapted vaccines provide some protection against a range of outcomes from FLiRT-mutated-related COVID-19, evidence suggests that vaccines better matched to currently circulating sub-lineages can help further improve protection against symptomatic disease and severe COVID-19. Following guidance from regulatory authorities on the requirements for strain changes, Pfizer/BioNTech filed data showing that the FLiRT-mutated-adapted (KP.2) monovalent COVID-19 vaccine generates improved responses against circulating sublineages, compared to the 2023-2024 Omicron XBB-adapted COVID-19 vaccine. On June 27, 2024, the Advisory Committee on Immunization Practices recommended an updated 2024-2025 COVID-19 vaccine for all persons aged ≥6 months, regardless of prior vaccination history. On August 22nd 2024, FDA approved the KP.2 strain COVID-19 vaccine (2024-2025 Formula) for those aged >12 years ages and authorized its use in those 6 months through 11 years of age.
Research Question:
What is the real-world effectiveness of the Pfizer/BioNTech 2024-2025 formulation of the COVID-19 vaccine against symptomatic COVID-19, across different age groups, during periods when different subvariants are circulating, and by months since receipt of the 2024-2025 formulated COVID-19 vaccine dose?
Research Methods:
Population: In collaboration with CVS, Pfizer will conduct a retrospective study to analyze patients tested for SARS-CoV-2 on or after September 5th, 2024, which corresponds with 14 days following FDA approval of the 2024-2025 updated COVID-19 vaccine. CVS will leverage CVS MinuteClinic data on patients ≥5 years of age who are testing for SARS-CoV-2 to evaluate the effectiveness of the 2024-2025 Pfizer/BioNTech COVID-19 vaccine formulation against symptomatic SARS-CoV-2 infection.
Exposure: The exposure of interest will be receipt of the Pfizer-BioNTech BNT162b2 COVID-19 vaccine (2024-2025 formulation) ≥14 days before testing for SARS-CoV-2. The reference group for the overall VE will be no receipt of the Pfizer-BioNTech BNT162b2 COVID-19 vaccine (2024-2025 formulation) or any other 2024-2025 formulated COVID-19 vaccine regardless of prior vaccination history.
Outcome: Cases will be defined as patients testing positive for SARS-CoV-2 infection by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom. Controls will be defined as participants testing negative for SARS-CoV-2 by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom during the same period.
Calculation: Estimated vaccine effectiveness will be calculated as 1 minus the odds ratio from logistic regression models multiplied by 100.
- Conditions
- COVID-19
- Being tested
- Pfizer-BioNTech BNT162b2 COVID-19 Vaccinated, Not vaccinated with 2024-2025 formulated COVID-19 vaccine
- Keywords
- SARS-CoV-2, COVID-19, Omicron, KP.2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pfizer-BioNTech BNT162b2 COVID-19 VaccinatedBiological
Also called Exposed
Non-interventional observed exposure of the receipt of the Pfizer-BioNTech BNT162b2 COVID-19 vaccine (2024-2025 formulation) ≥14 days before testing for SARS-CoV-2
Not vaccinated with 2024-2025 formulated COVID-19 vaccineBiological
Also called Unexposed
The reference group will be no receipt of the Pfizer-BioNTech BNT162b2 COVID-19 vaccine (2024-2025 formulation), or any other 2024-2025 formulated COVID-19 vaccine, ≥14 days before testing for SARS-CoV-2.
| Study group | Role | What they receive |
|---|---|---|
| Participants testing positive for COVID-19 (i.e., cases) | Participants testing positive for SARS-CoV-2 infection by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom Receives: Biological: Pfizer-BioNTech BNT162b2 COVID-19 Vaccinated; Biological: Not vaccinated with 2024-2025 formulated COVID-19 vaccine | |
| Participants testing negative for COVID-19 (i.e. negative controls) | Participants testing negative for SARS-CoV-2 by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom Receives: Biological: Pfizer-BioNTech BNT162b2 COVID-19 Vaccinated; Biological: Not vaccinated with 2024-2025 formulated COVID-19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Pfizer/BioNTech 2024-2025 formulation vaccinated patients who test positive for SARS-CoV-2 ≥14 days after receipt of vaccine
Exposed Cases will be defined as patients testing positive for SARS-CoV-2 infection by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom and were vaccinated with the 2024-2025 formulation of the Pfizer/BioNTech vaccine ≥14 days prior to testing.
Measured: September 2024 - April 2025
Number of COVID-19 2024-2025 formulation unvaccinated patients who test positive for SARS-CoV-2
Unexposed Cases will be defined as patients testing positive for SARS-CoV-2 infection by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom and were not vaccinated with any 2024-2025 formulation of COVID-19 vaccine ≥14 days prior to testing.
Measured: September 2024 - April 2025
Number of Pfizer/BioNTech 2024-2025 formulation vaccinated patients who test negative for SARS-CoV-2 ≥14 days after receipt of vaccine
Exposed Controls will be defined as patients testing negative for SARS-CoV-2 infection by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom and were vaccinated with the 2024-2025 formulation of the Pfizer/BioNTech vaccine ≥14 days prior to testing.
Measured: September 2024 - April 2025
Number of COVID-19 2024-2025 formulation unvaccinated patients who test negative for SARS-CoV-2
Unexposed Controls will be defined as patients testing negative for SARS-CoV-2 infection by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom and were not vaccinated with any 2024-2025 formulation of COVID-19 vaccine ≥14 days prior to testing.
Measured: September 2024 - April 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start25 Nov 2024
- Primary completion6 Jun 2025
- Study completion6 Jun 2025
Why it stopped: This secondary data analysis of symptomatic CVS MinuteClinics patients testing for SARS-CoV-2 was terminated due to incomplete data on KP.2 vaccination status (exposure). Termination was not based on any safety concerns or regulatory requirements.
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.
- More trials run by PfizerThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CVS Caremark
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703190
- Sponsor's protocol ID
- C4591068
- Other IDs
- NCT06703190
- Acronym
- C4591068
- Status last verified
- Nov 2025
- First submitted
- 22 Nov 2024
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimated Vaccine Effectiveness (VE) and Durability of Pfizer/BioNTech 2024-2025 COVID-19 (Coronavirus Disease 2019) Vaccine
- ClinicalTrials.gov ID
- NCT06703190
- Acronym / sponsor ID
- C4591068 / C4591068
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, COVID-19, Omicron, KP.2
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This secondary data analysis of symptomatic CVS MinuteClinics patients testing for SARS-CoV-2 was terminated due to incomplete data on KP.2 vaccination status (exposure). Termination was not based on any safety concerns or regulatory requirements.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- CVS Caremark
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 25 Nov 2024 (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 study is a retrospective case control analysis on the real-world effectiveness of the Pfizer-BioNTech BNT162b2 vaccine (2024-2025 formulation) against symptomatic SARS-CoV-2 infection among CVS MinuteClinic patients testing for SARS-CoV-2, across different age groups, during periods of various variant circulation, and by months since receipt of vaccine dose.
Detailed description
Background:
Omicron and its sublineages have comprised of the majority of SARS-CoV-2 genomes sequenced by the Centers for Disease Control and Prevention (CDC) since December 2021. KP.2 was first identified as a circulating variant under monitoring (VUM) by the World Health Organization in March 2024. FLiRT-mutated subvariants (including KP.2 and recent FluQE-mutated subvariants) have been the predominant variants sequenced in the US throughout 2024. FLiRT-mutated sub-lineages are antigenically distant from prior circulating SARS-CoV-2 lineages, including Omicron XBB, Omicron BA.4/BA.5 and the original SARS-CoV-2 wild-type strain. While Omicron XBB-adapted vaccines provide some protection against a range of outcomes from FLiRT-mutated-related COVID-19, evidence suggests that vaccines better matched to currently circulating sub-lineages can help further improve protection against symptomatic disease and severe COVID-19. Following guidance from regulatory authorities on the requirements for strain changes, Pfizer/BioNTech filed data showing that the FLiRT-mutated-adapted (KP.2) monovalent COVID-19 vaccine generates improved responses against circulating sublineages, compared to the 2023-2024 Omicron XBB-adapted COVID-19 vaccine. On June 27, 2024, the Advisory Committee on Immunization Practices recommended an updated 2024-2025 COVID-19 vaccine for all persons aged ≥6 months, regardless of prior vaccination history. On August 22nd 2024, FDA approved the KP.2 strain COVID-19 vaccine (2024-2025 Formula) for those aged >12 years ages and authorized its use in those 6 months through 11 years of age.
Research Question:
What is the real-world effectiveness of the Pfizer/BioNTech 2024-2025 formulation of the COVID-19 vaccine against symptomatic COVID-19, across different age groups, during periods when different subvariants are circulating, and by months since receipt of the 2024-2025 formulated COVID-19 vaccine dose?
Research Methods:
Population: In collaboration with CVS, Pfizer will conduct a retrospective study to analyze patients tested for SARS-CoV-2 on or after September 5th, 2024, which corresponds with 14 days following FDA approval of the 2024-2025 updated COVID-19 vaccine. CVS will leverage CVS MinuteClinic data on patients ≥5 years of age who are testing for SARS-CoV-2 to evaluate the effectiveness of the 2024-2025 Pfizer/BioNTech COVID-19 vaccine formulation against symptomatic SARS-CoV-2 infection.
Exposure: The exposure of interest will be receipt of the Pfizer-BioNTech BNT162b2 COVID-19 vaccine (2024-2025 formulation) ≥14 days before testing for SARS-CoV-2. The reference group for the overall VE will be no receipt of the Pfizer-BioNTech BNT162b2 COVID-19 vaccine (2024-2025 formulation) or any other 2024-2025 formulated COVID-19 vaccine regardless of prior vaccination history.
Outcome: Cases will be defined as patients testing positive for SARS-CoV-2 infection by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom. Controls will be defined as participants testing negative for SARS-CoV-2 by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom during the same period.
Calculation: Estimated vaccine effectiveness will be calculated as 1 minus the odds ratio from logistic regression models multiplied by 100.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants testing positive for COVID-19 (i.e., cases) | – | Biological: Pfizer-BioNTech BNT162b2 COVID-19 Vaccinated, Biological: Not vaccinated with 2024-2025 formulated COVID-19 vaccineParticipants testing positive for SARS-CoV-2 infection by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom |
| Participants testing negative for COVID-19 (i.e. negative controls) | – | Biological: Pfizer-BioNTech BNT162b2 COVID-19 Vaccinated, Biological: Not vaccinated with 2024-2025 formulated COVID-19 vaccineParticipants testing negative for SARS-CoV-2 by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include retrospectively gathered data from those testing for SARS-CoV-2 at a CVS MinuteClinic
Key inclusion criteria (7 listed)
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- MinuteClinic Patients (at least 5 years of age) testing for SARS-CoV-2 on or after September 5th 2024 (at least 14 days after FDA approval of the updated 2024-2025 COVID-19 vaccine formulation); AND
- At least one symptom reported on the ICATT questionnaire; AND
- No evidence of a positive SARS-CoV-2 test or COVID-19 diagnosis (or COVID-19 antiviral medications picked up at CVS) within the prior 90 days; AND
- Vaccine status reported on the ICATT questionnaire and/or ability to confirm receipt of the 2024-2025 formulated COVID-19 vaccine via CVS or Aetna records; AND
Key exclusion criteria (9 listed)
- Those testing at drive-thru locations;
- Those who tested but are without a completed ICATT questionnaire
- Those with invalid test results
- Those not reporting any symptoms
- Those who received a 2024-2025 formulated COVID-19 vaccine other than from Pfizer/BioNTech (confirmed via a combination of patient- or provider-report and validation against CVS or Aetna vaccination data).
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 |
|---|---|---|
| Pfizer-BioNTech BNT162b2 COVID-19 VaccinatedAlso: ExposedNon-interventional observed exposure of the receipt of the Pfizer-BioNTech BNT162b2 COVID-19 vaccine (2024-2025 formulation) ≥14 days before testing for SARS-CoV-2 | Biological | Participants testing negative for COVID-19 (i.e. negative controls), Participants testing positive for COVID-19 (i.e., cases) |
| Not vaccinated with 2024-2025 formulated COVID-19 vaccineAlso: UnexposedThe reference group will be no receipt of the Pfizer-BioNTech BNT162b2 COVID-19 vaccine (2024-2025 formulation), or any other 2024-2025 formulated COVID-19 vaccine, ≥14 days before testing for SARS-CoV-2. | Biological | Participants testing negative for COVID-19 (i.e. negative controls), Participants testing positive for COVID-19 (i.e., cases) |
Primary outcome
Number of Pfizer/BioNTech 2024-2025 formulation vaccinated patients who test positive for SARS-CoV-2 ≥14 days after receipt of vaccine
Time frame: September 2024 - April 2025
Exposed Cases will be defined as patients testing positive for SARS-CoV-2 infection by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom and were vaccinated with the 2024-2025 formulation of the Pfizer/BioNTech vaccine ≥14 days prior to testing.
Number of COVID-19 2024-2025 formulation unvaccinated patients who test positive for SARS-CoV-2
Time frame: September 2024 - April 2025
Unexposed Cases will be defined as patients testing positive for SARS-CoV-2 infection by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom and were not vaccinated with any 2024-2025 formulation of COVID-19 vaccine ≥14 days prior to testing.
Number of Pfizer/BioNTech 2024-2025 formulation vaccinated patients who test negative for SARS-CoV-2 ≥14 days after receipt of vaccine
Time frame: September 2024 - April 2025
Exposed Controls will be defined as patients testing negative for SARS-CoV-2 infection by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom and were vaccinated with the 2024-2025 formulation of the Pfizer/BioNTech vaccine ≥14 days prior to testing.
Number of COVID-19 2024-2025 formulation unvaccinated patients who test negative for SARS-CoV-2
Time frame: September 2024 - April 2025
Unexposed Controls will be defined as patients testing negative for SARS-CoV-2 infection by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom and were not vaccinated with any 2024-2025 formulation of COVID-19 vaccine ≥14 days prior to testing.
Results and safety
The study was stopped early (reason given: This secondary data analysis of symptomatic CVS MinuteClinics patients testing for SARS-CoV-2 was terminated due to incomplete data on KP.2 vaccination status (exposure). Termination was not based on any safety concerns or regulatory requirements.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
1 site 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 Pfizer at 1 site 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 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: stopped early, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: This secondary data analysis of symptomatic CVS MinuteClinics patients testing for SARS-CoV-2 was terminated due to incomplete data on KP.2 vaccination status (exposure). Termination was not based on any safety concerns or regulatory requirements.). Results are not available in the source record.
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?
Number of Pfizer/BioNTech 2024-2025 formulation vaccinated patients who test positive for SARS-CoV-2 ≥14 days after receipt of vaccine (time frame: September 2024 - April 2025). 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?
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 6 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.