Chemical InjuryCBRNEObsNCT05026645
The Medical Management in Patients Exposed to Weapons of Mass Destruction
An observational study of Chemical Injury and Chemicals; Intoxication, run by St. Justine's Hospital at 15 sites in 6 countries.
Trial summary
Observation study measuring medical response in contaminated environment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chemical Injury, Chemicals; Intoxication, Acute Respiratory Distress Syndrome
- What is being tested?
- Clinical interventions performed in acute settings (contaminated environment), Protection (clinician and patient) and Decontamination (clinician and patient)
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 15 sitesin 6 countries
- Study dates
- 1 Oct 2020to 1 Dec 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
Who may be able to join
- a CBRNE attack caused at least one casualty who required the assistance of the participating health care system (e.g.: physicians, nurses, paramedics and other health-care specialists of a medical facility) during a medical extraction from the incident site until admission to a medical facility;
- Patients are eligible if they were exposed to the CBRNE attack;
- Medical information concerning the CBRNE exposures, even if partial, is accessible to health care professionals for the purposes of filling out the online case report form (eCRF);
- Participants must be able to complete the online case report form in English; and
- The approval of an Ethics Review Board is obtained by each medical centre participant.
Who cannot join
- A negative response to any of the inclusion criteria results in an exclusion.
Trial locations and contacts
15 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 6 countries
Canada7 sites
École de Technologie Supérieure Université du Québec
Montreal, Quebec, H3C 1K3
Research Center of the CHU St-Justine, University of Montreal
Montreal, Quebec, H3T 1C5
Royal Canadian Medical Corps
Ottawa, Ontario, K1A0K2
Research Centre, Quebec Heart and Lung Institute, Laval University
Québec, Quebec, G1V 4G5
Medical Intelligence CBRNE Inc.
Québec, Quebec, G1V0C8
Biomedical Telematics Laboratory Platform of the Quebec Respiratory Health Research Network
Sherbrooke, Quebec, J1K 2R1
Centre for Defence and Security Studies, University of Manitoba
Winnipeg, Manitoba, R3T 2N2
Japan3 sites
Tokyo Women's Medical University, Department of Intensive Care Medicine
Tokyo, Shinjuku-ku
Department of Critical care, Miyagi Children's Hospital
Tokyo
Department of Disaster Medical Management, The University of Tokyo Hospital
Tokyo
United Kingdom2 sites
Surrey and Sussex Healthcare NHS Trust
Surrey Quays, Redhill, RH1 5RH
CBRNE World Journal
Winchester, SO23 8UT
United States1 site
Director, Unconventional Weapons & Technology Division, National Consortium for the Study of Terrorism and Responses to Terrorism University of Maryland
College Park, Maryland, 20740
Czechia1 site
University of Finance and Administration Department of Criminology and Forensic Disciplines
Prague, Prague, 10100
About this study
Official title: Acute Care For Patients Exposed to a Chemical, Biological, Radiological, Nuclear, Explosive: Attack: Protocol For An International Multicentric Observational Study
Observation study measuring medical response in contaminated environment.
Read the detailed description
This is an ongoing multicentric observational study that aims to assess the medical response to chemical, biological, radiological, nuclear, explosive (cbrne) events during the last five (5) decades (i.e.: 1970-2020), and in any future cbrne attack that might occur within the next 15 years (i.e.: 2021-2036). Of note, the data collection will be performed retrospectively and after sites review ethic board (REB) approval.
- Conditions
- Chemical Injury, Chemicals; Intoxication, Acute Respiratory Distress Syndrome, Distress Respiratory Syndrome, Medical Emergencies
- Being tested
- Clinical interventions performed in acute settings (contaminated environment), Protection (clinician and patient), Decontamination (clinician and patient)
- Keywords
- CBRNE Defence, Acute Settings, Pre-Hospital Settings, Decontamination, Protection, Respiratory Insults, Treatments
- Medical subject headings
- Respiratory Distress Syndrome, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical interventions performed in acute settings (contaminated environment)Procedure or surgery
Any clinical intervention performed on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic).
Protection (clinician and patient)Procedure or surgery
As interrelated competence of the clinical intervention, any protection procedure and capability applied on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in closed/contact with.
Decontamination (clinician and patient)Procedure or surgery
As interrelated competence of the clinical intervention and protection, any decontamination procedure and capability applied on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in closed/contact with. This crucial step is usually expected prior the patient's transfer into a clean zone like the emergency room or its equivalent.
| Study group | Role | What they receive |
|---|---|---|
| adult inflicted by a CBRNE weapon | Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. Receives: Procedure: Clinical interventions performed in acute settings (contaminated environment); Procedure: Protection (clinician and patient); Procedure: Decontamination (clinician and patient) | |
| Infant inflicted by a CBRNE weapon | Part of the population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. Receives: Procedure: Clinical interventions performed in acute settings (contaminated environment); Procedure: Protection (clinician and patient); Procedure: Decontamination (clinician and patient) | |
| Women inflicted by a CBRNE weapon | Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. Receives: Procedure: Clinical interventions performed in acute settings (contaminated environment); Procedure: Protection (clinician and patient); Procedure: Decontamination (clinician and patient) | |
| Men inflicted by a CBRNE weapon | Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. Receives: Procedure: Clinical interventions performed in acute settings (contaminated environment); Procedure: Protection (clinician and patient); Procedure: Decontamination (clinician and patient) | |
| Elderly inflicted by a CBRNE weapon | Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. Receives: Procedure: Clinical interventions performed in acute settings (contaminated environment); Procedure: Protection (clinician and patient); Procedure: Decontamination (clinician and patient) | |
| Diagnosed with chronic disease(s) inflicted by a CBRNE weapon | Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. Receives: Procedure: Clinical interventions performed in acute settings (contaminated environment); Procedure: Protection (clinician and patient); Procedure: Decontamination (clinician and patient) | |
| Clinician (adult) whom performs his/her clinical interventions | Clinician (adult) whom performs his/her clinical interventions while integrating competences in protections and decontamination. Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. This is the case of when the clinician is required to ensure safety toward his/her patient while performing his/her interventions \& procedures. Receives: Procedure: Clinical interventions performed in acute settings (contaminated environment); Procedure: Protection (clinician and patient); Procedure: Decontamination (clinician and patient) | |
| Clinician (adult) injured by duties circumstances | Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. This is the case of when the clinician becomes inflicted by a CBRNE weapon while intervening toward contaminated patient due to any failure in protection and decontamination. Receives: Procedure: Clinical interventions performed in acute settings (contaminated environment); Procedure: Protection (clinician and patient); Procedure: Decontamination (clinician and patient) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention and location
The percentage of patients to whom the World Health Organization's healthcare guidelines were applied without any delay (i.e.: during a medical extraction/evacuation)
Measured: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).
Secondary outcomes (4)
Contamination is under-control due to efficient protective measures applied during a medical extraction/evacuation
The percentage of patients whose health condition remained stable during a medical extraction due to efficient WHO's protective measures applied
Measured: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).
Contamination under-control due to efficient decontamination measures applied during a medical extraction/evacuation
The percentage of patients whose health condition remained stable during a medical extraction due to efficient WHO's decontamination measures applied
Measured: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).
Deterioration of the patient's health condition due to compromised means of protection
The percentage of patients whose health condition deteriorate during a medical extraction due to the misuse of WHO's protective measures (e.g.: mask, suit, gloves, boots, etc).
Measured: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).
Deterioration of the patient's health condition due to compromised means of decontamination
The percentage of patients whose health condition deteriorated during a medical extraction due to the misuse of WHO's decontamination measures (e.g.: immediate (roughly) or/and thorough (specialized one)).
Measured: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).
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 start1 Oct 2020
- Primary completion1 Nov 2036 (estimated)
- Study completion1 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemical InjuryStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Quebec Heart and Lung Institute, Quebec City, Canada, Sorbonne University, Medical Intelligence CBRNE inc.; Quebec City, Canada, Department of Intensive Care Medicine, Tokyo, Japan, Centre for Defence and Security Studies, University of Manitoba, Winnipeg, Canada, Biomedical Telematics Laboratory, Quebec Respiratory Health Research Network, Sherbrooke, Canada, Tokyo University, Tokyo Women's Medical University, University of Maryland, College Park
- Responsible party
- Principal investigator, Stephane Bourassa, St. Justine's Hospital
- Investigators
- Stephane Bourassa, Principal investigator, Ste-Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026645
- Sponsor's protocol ID
- 2020-2561
- Acronym
- CBRNEObs
- Status last verified
- Sep 2025
- First submitted
- 18 Aug 2021
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this stage, we do have any plan. However, for the interest of pursuing the research, that matter will require to be addressed in due time.
Publications
Bourassa S, Noebert D, Dauphin M, Rambaud J, Kawaguchi A, Leger F, Beijer D, Fortier Y, Dligui M, Ivanovski H, Simard S, Jouvet P, Leclerc J. Acute care for patients exposed to a chemical attack: protocol for an international multicentric observational study. BMJ Open. 2022 Sep 29;12(9):e065015. doi: 10.1136/bmjopen-2022-065015.
PubMed 36175098
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Care For Patients Exposed to a Chemical, Biological, Radiological, Nuclear, Explosive: Attack: Protocol For An International Multicentric Observational Study
- ClinicalTrials.gov ID
- NCT05026645
- Acronym / sponsor ID
- CBRNEObs / 2020-2561
- Conditions
- Chemical Injury, Chemicals; Intoxication, Acute Respiratory Distress Syndrome, Distress Respiratory Syndrome, Medical Emergencies
- Keywords
- CBRNE Defence, Acute Settings, Pre-Hospital Settings, Decontamination, Protection, Respiratory Insults, Treatments
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- Quebec Heart and Lung Institute, Quebec City, Canada, Sorbonne University, Medical Intelligence CBRNE inc.; Quebec City, Canada, Department of Intensive Care Medicine, Tokyo, Japan, Centre for Defence and Security Studies, University of Manitoba, Winnipeg, Canada, Biomedical Telematics Laboratory, Quebec Respiratory Health Research Network, Sherbrooke, Canada, Tokyo University, Tokyo Women's Medical University, University of Maryland, College Park
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Nov 2036 (estimated)
- Study completion
- 1 Dec 2036 (estimated)
- First posted
- 30 Aug 2021 (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.
Observation study measuring medical response in contaminated environment.
Detailed description
This is an ongoing multicentric observational study that aims to assess the medical response to chemical, biological, radiological, nuclear, explosive (cbrne) events during the last five (5) decades (i.e.: 1970-2020), and in any future cbrne attack that might occur within the next 15 years (i.e.: 2021-2036). Of note, the data collection will be performed retrospectively and after sites review ethic board (REB) approval.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| adult inflicted by a CBRNE weapon | – | Procedure: Clinical interventions performed in acute settings (contaminated environment), Procedure: Protection (clinician and patient), Procedure: Decontamination (clinician and patient)Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. |
| Infant inflicted by a CBRNE weapon | – | Procedure: Clinical interventions performed in acute settings (contaminated environment), Procedure: Protection (clinician and patient), Procedure: Decontamination (clinician and patient)Part of the population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. |
| Women inflicted by a CBRNE weapon | – | Procedure: Clinical interventions performed in acute settings (contaminated environment), Procedure: Protection (clinician and patient), Procedure: Decontamination (clinician and patient)Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. |
| Men inflicted by a CBRNE weapon | – | Procedure: Clinical interventions performed in acute settings (contaminated environment), Procedure: Protection (clinician and patient), Procedure: Decontamination (clinician and patient)Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. |
| Elderly inflicted by a CBRNE weapon | – | Procedure: Clinical interventions performed in acute settings (contaminated environment), Procedure: Protection (clinician and patient), Procedure: Decontamination (clinician and patient)Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. |
| Diagnosed with chronic disease(s) inflicted by a CBRNE weapon | – | Procedure: Clinical interventions performed in acute settings (contaminated environment), Procedure: Protection (clinician and patient), Procedure: Decontamination (clinician and patient)Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. |
| Clinician (adult) whom performs his/her clinical interventions | – | Procedure: Clinical interventions performed in acute settings (contaminated environment), Procedure: Protection (clinician and patient), Procedure: Decontamination (clinician and patient)Clinician (adult) whom performs his/her clinical interventions while integrating competences in protections and decontamination. Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. This is the case of when the clinician is required to ensure safety toward his/her patient while performing his/her interventions \& procedures. |
| Clinician (adult) injured by duties circumstances | – | Procedure: Clinical interventions performed in acute settings (contaminated environment), Procedure: Protection (clinician and patient), Procedure: Decontamination (clinician and patient)Part of the Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system. This is the case of when the clinician becomes inflicted by a CBRNE weapon while intervening toward contaminated patient due to any failure in protection and decontamination. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population is being studied includes any individual who was affected by CBRNE attacks and needed an intervention of the healthcare system.
Key inclusion criteria (5 listed)
- a CBRNE attack caused at least one casualty who required the assistance of the participating health care system (e.g.: physicians, nurses, paramedics and other health-care specialists of a medical facility) during a medical extraction from the incident site until admission to a medical facility;
- Patients are eligible if they were exposed to the CBRNE attack;
- Medical information concerning the CBRNE exposures, even if partial, is accessible to health care professionals for the purposes of filling out the online case report form (eCRF);
- Participants must be able to complete the online case report form in English; and
- The approval of an Ethics Review Board is obtained by each medical centre participant.
Key exclusion criteria (1 listed)
- A negative response to any of the inclusion criteria results in an exclusion.
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 |
|---|---|---|
| Clinical interventions performed in acute settings (contaminated environment)Any clinical intervention performed on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). | Procedure or surgery | Clinician (adult) injured by duties circumstances, Clinician (adult) whom performs his/her clinical interventions, Diagnosed with chronic disease(s) inflicted by a CBRNE weapon, Elderly inflicted by a CBRNE weapon, Infant inflicted by a CBRNE weapon, Men inflicted by a CBRNE weapon, Women inflicted by a CBRNE weapon, adult inflicted by a CBRNE weapon |
| Protection (clinician and patient)As interrelated competence of the clinical intervention, any protection procedure and capability applied on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in closed/contact with. | Procedure or surgery | Clinician (adult) injured by duties circumstances, Clinician (adult) whom performs his/her clinical interventions, Diagnosed with chronic disease(s) inflicted by a CBRNE weapon, Elderly inflicted by a CBRNE weapon, Infant inflicted by a CBRNE weapon, Men inflicted by a CBRNE weapon, Women inflicted by a CBRNE weapon, adult inflicted by a CBRNE weapon |
| Decontamination (clinician and patient)As interrelated competence of the clinical intervention and protection, any decontamination procedure and capability applied on the patient inflicted by at least one of Chemical, Biological, Radiological, Nuclear, Explosive (CBRNE) weapons in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in closed/contact with. This crucial step is usually expected prior the patient's transfer into a clean zone like the emergency room or its equivalent. | Procedure or surgery | Clinician (adult) injured by duties circumstances, Clinician (adult) whom performs his/her clinical interventions, Diagnosed with chronic disease(s) inflicted by a CBRNE weapon, Elderly inflicted by a CBRNE weapon, Infant inflicted by a CBRNE weapon, Men inflicted by a CBRNE weapon, Women inflicted by a CBRNE weapon, adult inflicted by a CBRNE weapon |
Primary outcome
Intervention and location
Time frame: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).
The percentage of patients to whom the World Health Organization's healthcare guidelines were applied without any delay (i.e.: during a medical extraction/evacuation)
4 secondary outcomes
Contamination is under-control due to efficient protective measures applied during a medical extraction/evacuation
Time frame: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).
Contamination under-control due to efficient decontamination measures applied during a medical extraction/evacuation
Time frame: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).
Deterioration of the patient's health condition due to compromised means of protection
Time frame: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).
Deterioration of the patient's health condition due to compromised means of decontamination
Time frame: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Derived from this study: PubMed 36175098Bourassa S, Noebert D, Dauphin M, Rambaud J, Kawaguchi A, Leger F, Beijer D, Fortier Y, Dligui M, Ivanovski H, Simard S, Jouvet P, Leclerc J. Acute care for patients exposed to a chemical attack: protocol for an international multicentric observational study. BMJ Open. 2022 Sep 29;12(9):e065015. doi: 10.1136/bmjopen-2022-065015.
- Individual participant dataSharing planned: Undecided. At this stage, we do have any plan. However, for the interest of pursuing the research, that matter will require to be addressed in due time.
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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.
Stephane Bourassa principal investigator
Ste-Justine's Hospital
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemical Injury and Chemicals; Intoxication, run by St. Justine's Hospital at 15 sites in 6 countries.
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 5 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: enrolling by invitation, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Canada, Japan, United Kingdom, United States, Czechia and 1 more country. 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?
This study is still under way. Results are not available in the source record yet.
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?
Intervention and location (time frame: At the patient's admission at the hospital emergency room (i.e.: end-point of the medical extraction/evacuation).). 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 NCT05026645, which also lists 1 linked publication.
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 1 Oct 2025.