Diabetes MellitusRIPPLE-CNCT05813652
Relative Impacts on Preventative Primary Care--a Longitudinal Evaluation of COVID-19:Phase 1
An observational study of Diabetes Mellitus and Congestive Heart Failure, run by McMaster University at 1 site in Canada.
Trial summary
The goal of this observational study is to describe the impacts of COVID-19 on primary care chronic condition management in Canada within various patient populations. This will be done by analyzing primary care electronic medial record (EMR) data from the Canadian Primary Care Sentinel Surveillance Network (CPCSSN)… Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Diabetes Mellitus, Congestive Heart Failure, Chronic Kidney Diseases
- What is being tested?
- Pre-pandemic time period (Jun 22, 2018 to March 12, 2020) and Peri-pandemic time period (March 13, 2020 to December 3, 2021)
- How many people
- 919,928 participants
- Where
- 1 siteCanada
- Study dates
- 5 Oct 2022to 31 Mar 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 18 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is all patients who were age 18 years and older in 2018. As only year of birth is available, we will use the mid-point of the year for age calculation. We will include patients who have had at least one encounter or form of contact with their primary care clinic between the dates of March 13, 2018 and March 13, 2020. People with a deceased status during the study period will be included up to the point of death.
Who may be able to join
- 18 years of age or older as of 2018
- Records included in the CPCSSN database
- Patient had at least one encounter with their clinic between March 13, 2018 and March 13, 2020
Who cannot join
- Patients aged 105 or older as of 2018 will be excluded due to possibility of data entry error
Trial locations and contacts
1 site in 1 country.
Canada1 site
McMaster University Department of Family Medicine
Hamilton, Ontario, L8P 1H6
About this study
Official title: Relative Impacts on Preventative Primary Care--a Longitudinal Evaluation of COVID-19 (Phase 1: A Retrospective Cohort Analysis)
The goal of this observational study is to describe the impacts of COVID-19 on primary care chronic condition management in Canada within various patient populations. This will be done by analyzing primary care electronic medial record (EMR) data from the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) database, including data on primary care encounters, as well as various markers for chronic conditions.
The research questions to be investigated are:
1a) What are the changes to the management of chronic conditions in primary care since the onset of the COVID-19 pandemic?
1b) How do these changes differ by age, health status, and socioeconomic status?
Read the detailed description
This is a retrospective closed cohort study, using a single-arm, pre-post design. The objectives of this study are to describe the impacts of COVID-19 on access, comprehensiveness and appropriateness among adult patients with chronic diseases, and to determine whether changes were associated with socio-demographic characteristics and multi-morbidity. This will be done using using electronic medial record (EMR) data made available by the CPCSSN network. CPCSSN is a research network supported by a primary care EMR database, comprising over 1500 physicians, and nearly 2 million patients from across Canada.
We will be examining prevention and management activities for several exemplar chronic conditions that have a validated CPCSSN case definition and substantial prevalence in primary care (e.g. diabetes, heart failure, etc.). CPCSSN data between 2018-2021 will be analyzed for changes in management of various chronic conditions prior to, and through phases of the pandemic. Changes will also be examined among specific sub-groups of adults, including those with multi-morbidity and socio-economic vulnerabilities.
The primary exposure is the onset of the pandemic: March 13, 2020 to December 3, 2021 versus the equal time frame prior. March 13, 2020 was selected as the date when Canadian provincial governments began enforcing various public health and safety measures in response to the World Health Organization formally declaring the circulating SARS-CoV-2 as a pandemic on March 11, 2020.
We will be examining whether there have been changes in overall access, comprehensiveness, continuity and appropriateness of care (including potential decreases in burdensome or unnecessary care) by applying indicators that incorporate chronic condition monitoring (physical measures, lab tests and investigations), prescriptions, referrals and preventive care, to chronic condition patient populations.
- Conditions
- Diabetes Mellitus, Congestive Heart Failure, Chronic Kidney Diseases, Chronic Obstructive Pulmonary Disease, Depression, Anxiety, Osteoarthritis
- Being tested
- Pre-pandemic time period (Jun 22, 2018 to March 12, 2020), Peri-pandemic time period (March 13, 2020 to December 3, 2021)
- Medical subject headings
- Diabetes Mellitus, Heart Failure, Renal Insufficiency, Chronic, Pulmonary Disease, Chronic Obstructive, Depression, Anxiety Disorders, Osteoarthritis, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-pandemic time period (Jun 22, 2018 to March 12, 2020)Other
The primary exposure is the time period of the pandemic (March 13, 2020 to Dec 3, 2021), compared to pre-pandemic (Jun 22, 2018 to pandemic onset March 12, 2020)
Peri-pandemic time period (March 13, 2020 to December 3, 2021)Other
The primary exposure is the time period of the pandemic (March 13, 2020 to Dec 3, 2021), compared to pre-pandemic (Jun 22, 2018 to pandemic onset March 12, 2020)
| Study group | Role | What they receive |
|---|---|---|
| RIPPLE-C cohort | This is a retrospective closed cohort study using a single-arm, pre-post design. Therefore, we will be selecting patients from the CPCSSN database to create our single-arm cohort. Patients included in this cohort will be 18 years of age or older, and will have had at least one contact with their primary care clinic between the dates of March 13, 2018 and March 13, 2020. Receives: Other: Pre-pandemic time period (Jun 22, 2018 to March 12, 2020); Other: Peri-pandemic time period (March 13, 2020 to December 3, 2021) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and types of encounters (access, comprehensiveness)
Overall number and types of patient encounters; number and types of chronic condition-related encounters for patients with specific chronic conditions (e.g. diabetes, heart failure, etc.). *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*
Measured: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start
Diagnoses addressed in encounters (comprehensiveness, appropriateness)
Overall number of diagnoses addressed per person, per year; number and proportion of encounters for specific chronic conditions addressed at least once a year; number of patients with specific chronic conditions (e.g. diabetes, heart failure, etc.) with condition-related encounters within 6 months, 12 months. *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age.*
Measured: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
Services provided (comprehensiveness)
Number of patients receiving pneumococcal vaccine, influenza vaccine; proportion of patients with specific chronic disease vaccinated for influenza *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*
Measured: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
Procedures performed (appropriateness)
Proportion of diabetic patients with foot exam in last 12 months *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*
Measured: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
Physical exams (appropriateness)
Proportion of patients (all patients and those grouped by chronic condition) with blood pressure measured every 6 months, or every 12 months (as appropriate for condition) *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*
Measured: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
Referrals made to specialists (comprehensiveness)
Overall number of referrals made to specialist providers; proportion of patients with specific chronic condition referred to specific specialties as appropriate based on condition (e.g. endocrinology for diabetic patients, cardiology for heart failure patients, etc.) *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*
Measured: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
Investigations performed (appropriateness)
Overall number of investigations and laboratory tests; number and frequency of investigations and laboratory tests performed for patients based on presence of chronic conditions (e.g. number of diabetic patients with HbA1C measured every 6 and 12 months) *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*
Measured: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
Monitoring results (appropriateness)
Proportion of patients with blood pressure below, at, or above target (as appropriate based on age and presence of chronic conditions); number and proportion of patients with systolic blood pressure in the following ranges: <130, 131-140, 141-150, 151-160, >160 *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*
Measured: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
Medications (appropriateness, comprehensiveness)
Overall number and frequency of medications specific to chronic conditions (e.g. insulin, oral antidiabetics for diabetic patients, angiotensin receptor blockers and/or angiotensin-converting enzyme inhibitors for heart failure patients, etc.); proportion of patients with specific chronic conditions on indicated medications; number of patients who smoke on nicotine replacement therapy *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*
Measured: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start5 Oct 2022
- Primary completion31 Jan 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Retrospective
- Enrolment
- 919,928 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Michelle Howard, McMaster University
- Investigators
- Michelle Howard, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813652
- Sponsor's protocol ID
- WI1-179885
- Acronym
- RIPPLE-C
- Status last verified
- Sep 2025
- First submitted
- 12 Apr 2023
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be available to other researchers.
Publications
Howard M, Freeman K, Hafid S, Vanstone M, Queenan J, Aubrey-Bassler K, Drummond N, Nicholson K, Mangin D. Primary care for depression before and during the COVID-19 pandemic: a retrospective pre-post study. BMJ Open. 2026 Jan 9;16(1):e108681. doi: 10.1136/bmjopen-2025-108681.
PubMed 41513423Howard M, Aubrey-Bassler K, Drummond N, Lussier MT, Queenan JA, Vanstone M, Nicholson K, Ramdyal A, Lawson J, Hafid S, Freeman K, Clark R, Mangin D. Effects of the COVID-19 Pandemic on Primary Health Care for Chronic Conditions in Canada: Protocol for a Retrospective Pre-Post Study Using National Practice-Based Research Network Data. JMIR Res Protoc. 2023 Jul 21;12:e49131. doi: 10.2196/49131.
PubMed 37477967
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Impacts on Preventative Primary Care--a Longitudinal Evaluation of COVID-19 (Phase 1: A Retrospective Cohort Analysis)
- ClinicalTrials.gov ID
- NCT05813652
- Acronym / sponsor ID
- RIPPLE-C / WI1-179885
- Conditions
- Diabetes Mellitus, Congestive Heart Failure, Chronic Kidney Diseases, Chronic Obstructive Pulmonary Disease, Depression, Anxiety, Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 919,928 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 14 Apr 2023 (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.
The goal of this observational study is to describe the impacts of COVID-19 on primary care chronic condition management in Canada within various patient populations. This will be done by analyzing primary care electronic medial record (EMR) data from the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) database, including data on primary care encounters, as well as various markers for chronic conditions.
The research questions to be investigated are:
1a) What are the changes to the management of chronic conditions in primary care since the onset of the COVID-19 pandemic?
1b) How do these changes differ by age, health status, and socioeconomic status?
Detailed description
This is a retrospective closed cohort study, using a single-arm, pre-post design. The objectives of this study are to describe the impacts of COVID-19 on access, comprehensiveness and appropriateness among adult patients with chronic diseases, and to determine whether changes were associated with socio-demographic characteristics and multi-morbidity. This will be done using using electronic medial record (EMR) data made available by the CPCSSN network. CPCSSN is a research network supported by a primary care EMR database, comprising over 1500 physicians, and nearly 2 million patients from across Canada.
We will be examining prevention and management activities for several exemplar chronic conditions that have a validated CPCSSN case definition and substantial prevalence in primary care (e.g. diabetes, heart failure, etc.). CPCSSN data between 2018-2021 will be analyzed for changes in management of various chronic conditions prior to, and through phases of the pandemic. Changes will also be examined among specific sub-groups of adults, including those with multi-morbidity and socio-economic vulnerabilities.
The primary exposure is the onset of the pandemic: March 13, 2020 to December 3, 2021 versus the equal time frame prior. March 13, 2020 was selected as the date when Canadian provincial governments began enforcing various public health and safety measures in response to the World Health Organization formally declaring the circulating SARS-CoV-2 as a pandemic on March 11, 2020.
We will be examining whether there have been changes in overall access, comprehensiveness, continuity and appropriateness of care (including potential decreases in burdensome or unnecessary care) by applying indicators that incorporate chronic condition monitoring (physical measures, lab tests and investigations), prescriptions, referrals and preventive care, to chronic condition patient populations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RIPPLE-C cohort | – | Other: Pre-pandemic time period (Jun 22, 2018 to March 12, 2020), Other: Peri-pandemic time period (March 13, 2020 to December 3, 2021)This is a retrospective closed cohort study using a single-arm, pre-post design. Therefore, we will be selecting patients from the CPCSSN database to create our single-arm cohort. Patients included in this cohort will be 18 years of age or older, and will have had at least one contact with their primary care clinic between the dates of March 13, 2018 and March 13, 2020. |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is all patients who were age 18 years and older in 2018. As only year of birth is available, we will use the mid-point of the year for age calculation. We will include patients who have had at least one encounter or form of contact with their primary care clinic between the dates of March 13, 2018 and March 13, 2020. People with a deceased status during the study period will be included up to the point of death.
Key inclusion criteria (3 listed)
- 18 years of age or older as of 2018
- Records included in the CPCSSN database
- Patient had at least one encounter with their clinic between March 13, 2018 and March 13, 2020
Key exclusion criteria (1 listed)
- Patients aged 105 or older as of 2018 will be excluded due to possibility of data entry error
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 |
|---|---|---|
| Pre-pandemic time period (Jun 22, 2018 to March 12, 2020)The primary exposure is the time period of the pandemic (March 13, 2020 to Dec 3, 2021), compared to pre-pandemic (Jun 22, 2018 to pandemic onset March 12, 2020) | Other | RIPPLE-C cohort |
| Peri-pandemic time period (March 13, 2020 to December 3, 2021)The primary exposure is the time period of the pandemic (March 13, 2020 to Dec 3, 2021), compared to pre-pandemic (Jun 22, 2018 to pandemic onset March 12, 2020) | Other | RIPPLE-C cohort |
Primary outcome
Number and types of encounters (access, comprehensiveness)
Time frame: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start
Overall number and types of patient encounters; number and types of chronic condition-related encounters for patients with specific chronic conditions (e.g. diabetes, heart failure, etc.). *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*
Diagnoses addressed in encounters (comprehensiveness, appropriateness)
Time frame: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
Overall number of diagnoses addressed per person, per year; number and proportion of encounters for specific chronic conditions addressed at least once a year; number of patients with specific chronic conditions (e.g. diabetes, heart failure, etc.) with condition-related encounters within 6 months, 12 months. *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age.*
Services provided (comprehensiveness)
Time frame: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
Number of patients receiving pneumococcal vaccine, influenza vaccine; proportion of patients with specific chronic disease vaccinated for influenza *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*
Procedures performed (appropriateness)
Time frame: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
Proportion of diabetic patients with foot exam in last 12 months *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*
Physical exams (appropriateness)
Time frame: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
Proportion of patients (all patients and those grouped by chronic condition) with blood pressure measured every 6 months, or every 12 months (as appropriate for condition) *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*
Referrals made to specialists (comprehensiveness)
Time frame: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
Overall number of referrals made to specialist providers; proportion of patients with specific chronic condition referred to specific specialties as appropriate based on condition (e.g. endocrinology for diabetic patients, cardiology for heart failure patients, etc.) *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*
Investigations performed (appropriateness)
Time frame: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
Overall number of investigations and laboratory tests; number and frequency of investigations and laboratory tests performed for patients based on presence of chronic conditions (e.g. number of diabetic patients with HbA1C measured every 6 and 12 months) *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*
Monitoring results (appropriateness)
Time frame: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
Proportion of patients with blood pressure below, at, or above target (as appropriate based on age and presence of chronic conditions); number and proportion of patients with systolic blood pressure in the following ranges: <130, 131-140, 141-150, 151-160, >160 *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*
Medications (appropriateness, comprehensiveness)
Time frame: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
Overall number and frequency of medications specific to chronic conditions (e.g. insulin, oral antidiabetics for diabetic patients, angiotensin receptor blockers and/or angiotensin-converting enzyme inhibitors for heart failure patients, etc.); proportion of patients with specific chronic conditions on indicated medications; number of patients who smoke on nicotine replacement therapy *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*
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 25 Sep 2025.
- Derived from this study: PubMed 41513423Howard M, Freeman K, Hafid S, Vanstone M, Queenan J, Aubrey-Bassler K, Drummond N, Nicholson K, Mangin D. Primary care for depression before and during the COVID-19 pandemic: a retrospective pre-post study. BMJ Open. 2026 Jan 9;16(1):e108681. doi: 10.1136/bmjopen-2025-108681.
- Derived from this study: PubMed 37477967Howard M, Aubrey-Bassler K, Drummond N, Lussier MT, Queenan JA, Vanstone M, Nicholson K, Ramdyal A, Lawson J, Hafid S, Freeman K, Clark R, Mangin D. Effects of the COVID-19 Pandemic on Primary Health Care for Chronic Conditions in Canada: Protocol for a Retrospective Pre-Post Study Using National Practice-Based Research Network Data. JMIR Res Protoc. 2023 Jul 21;12:e49131. doi: 10.2196/49131.
- Individual participant dataSharing planned: No. No individual participant data will be available to other researchers.
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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.
Michelle Howard, PhD principal investigator
McMaster University
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 Diabetes Mellitus and Congestive Heart Failure, run by McMaster University at 1 site in Canada.
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 3 inclusion and 1 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 25 Sep 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 Canada. 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?
Number and types of encounters (access, comprehensiveness) (time frame: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start). The study lists 9 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 NCT05813652, which also lists 2 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 25 Sep 2025.