Rheumatoid ArthritisPhase 2/3COVBIRDNCT05236491
COvid-19 Vaccine Booster in Immunocompromised Rheumatic Diseases
A Phase 2/3 study testing COVID-19 vaccine in people with Rheumatoid Arthritis and Autoimmune Rheumatologic Disease, run by Paul R Fortin at 2 sites in Canada.
Trial summary
People living with Systemic autoimmune rheumatic diseases (SARDs) face a new and urgent dilemma: immunosuppression increases risk for worse COVID-19 infection, yet an immune stimulation, such as vaccination, could re-activate their disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Autoimmune Rheumatologic Disease, Systemic Lupus Erythematosus
- What is being tested?
- COVID-19 vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 2 sitesCanada
- Study dates
- 9 Mar 2022to Dec 2023
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of a SARD (Rheumatoid arthritis, systemic lupus erythematosus (SLE), juvenile inflammatory arthritis, systemic sclerosis (SSc), idiopathic inflammatory myositis (IIM), overlap connective tissue diseases, mixed connective tissue disease, undifferentiated connective tissue diseases, giant-cell arteritis, and the ANCA-Associated Vasculitis: granulomatosis with polyangiitis (GPA; formerly known as Wegener's granulomatosis), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA; previously known as Churg-Strauss syndrome);
- Has received 3 or more doses of an mRNA vaccine;
- Age 18 years and older;
- Male or non-pregnant female;
- Rituximab treatment within last 12 months;
- Able to comprehend the study protocol and provide informed consent.
Who cannot join
- Any medical disease or condition that, in the opinion of the site Principal Investigator or sub-investigator, precludes study participation;
- Significant behavioral disturbances;
- Previous diagnosis of hepatitis B, hepatitis C or HIV;
- History of hypersensitivity or severe allergic reaction such as anaphylaxis to a component of the vaccine or to a previous vaccine;
- People who experienced inflammation of the heart or lining of the heart (myocarditis or pericarditis) after a previous dose of an mRNA vaccine or protein subunit vaccine.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Research Institute - McGill University Health Centre
Montreal, Quebec, H4A 3J1
Sonia Leger-Theriault, Sonia.Leger@MUHC.MCGILL.CA
Inés Colmegna, MD
- Recruiting
Centre de recherche du CHU de Québec - Université Laval
Québec, Quebec, G1V 4G2
Alexandra Godbout, alexandra.godbout@crchudequebec.ulaval.ca
About this study
People living with Systemic autoimmune rheumatic diseases (SARDs) face a new and urgent dilemma: immunosuppression increases risk for worse COVID-19 infection, yet an immune stimulation, such as vaccination, could re-activate their disease. Fear of vaccine-related disease reactivation is not of concern in other immunosuppressed groups (e.g. patients receiving chemotherapy or hemodialysis) but in SARDs, disease flare could lead to organ failure or even death. Specific research in this population is therefore critical. Moreover, among SARD patients, those on anti-CD-20 monoclonal antibody (mAb) (i.e. rituximab (anti-CD-20 mAb)), a medication used to treat inflammatory types of arthritis, have extremely low immunity post-COVID-19 mRNA vaccine. This study will test the hypothesis that a booster dose of a COVID-19 vaccine is safe and enhances post-vaccine humoral and cellular responses in SARDs patients on anti-CD-20 mAb treatment. The magnitude of this response depends on the type of COVID-19 vaccine administered and is optimal when the booster dose is a vaccine from a different group than the one used for primary immunization (mix-and-match approach).
Read the detailed description
Systemic autoimmune rheumatic diseases (SARDs) include rheumatoid arthritis (RA), systemic lupus (SLE), systemic vasculitis, and related diseases where immune system activity causes widespread inflammation in organs, leading to sickness, organ damage, disability, high health costs, and even death. With no cure, SARDs require life-long immunosuppression. People living with SARDs now face a new and urgent dilemma: immunosuppression increases risk for worse COVID-19 infection, yet an immune stimulation, such as vaccination, could re-activate their disease. Fear of vaccine-related disease reactivation is not of concern in other immunosuppressed groups (e.g. patients receiving chemotherapy or hemodialysis) but in SARDs, disease flare could lead to organ failure or even death. Specific research in this population is therefore critical. Moreover, among SARD patients, those on anti-CD-20 monoclonal antibody (mAb) (i.e. rituximab (anti-CD-20 mAb)) have extremely low humoral immunity post-COVID-19 mRNA vaccine. As of mid-July 2021, 1489 SARDs patients were actively treated with anti-CD-20 mAb in the province of Quebec (personal communication).
This study will test the hypothesis that a booster dose of a COVID-19 vaccine is safe and enhances post-vaccine humoral and cellular responses in SARDs patients on anti-CD-20 mAb treatment. The magnitude of this response depends on the type of COVID-19 vaccine administered and is optimal when the booster dose is a vaccine from a different group than the one used for primary immunization (mix-and-match approach).
Our goal is to recruit 287 adults with SARDs on anti-CD-20 mAb treatment post-three doses of an approved mRNA-COVID-19 vaccine in a non-randomized, open label, comparative clinical trial with pragmatic features. This includes persons with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), inflammatory immune myopathies (IIM), overlap and undifferentiated connective tissue diseases (OCTD and UCTD) and ANCA-associated vasculitis (AAV). We will test at entry all participants for their anti-SARS-CoV-2-spike receptor binding domain (anti-RBD) antibody response to their previous doses of mRNA-COVID-19 vaccines. For participants who have received 3 doses of an mRNA vaccine, we will offer them a choice between a fourth dose of an mRNA (vaccine and a dose of a protein subunit vaccine (PSV). For participants who have already received 4 doses of an mRNA vaccine in the community, they will be offered a dose of a protein subunit vaccine (PSV) as a fifth dose.
The primary study outcome will be the assessment of the safety and reactogenicity of a booster dose of COVID-19 vaccine using a mix-and-match strategy in immunocompromised rheumatic disease patients on an anti-CD-20 mAb. The secondary study outcome will be the humoral responses as measured by the anti-RBD Ab 28 days post vaccination. Exploratory outcomes include the cellular response at 28 days; the delayed humoral responses at 6 months; a comparison of the immunogenicity between types of vaccine (mRNA vs PSV); the evaluation of the effects of concomitant treatments on immunogenicity post-COVID-19 vaccine; the description of the rates of disease flares post booster dose of COVID-19 vaccine; and a description of the decision process for vaccine selection.
- Conditions
- Rheumatoid Arthritis, Autoimmune Rheumatologic Disease, Systemic Lupus Erythematosus, Systemic Vasculitis, Systemic Sclerosis, Scleroderma
- Being tested
- COVID-19 vaccine
- Medical subject headings
- Arthritis, Rheumatoid, Lupus Erythematosus, Systemic, Systemic Vasculitis, Scleroderma, Systemic, Scleroderma, Diffuse, Undifferentiated Connective Tissue Diseases, MASS syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccineBiological
Participants are to receive a booster dose of a COVID-19 vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Trajectory A | Active comparator | Participants who have received 3 doses of an mRNA vaccine, will be offered a choice between a fourth dose of an mRNA vaccine and a dose of a protein subunit vaccine (PSV) (Novavax NUVAXOVID)
For the Moderna SPIKEVAX Bivalent Original/Omicron BA.4/5: participants will receive one (1) intramuscular injection of 0.5 mL (50 mcg).
For the Novavax Nuvaxovid vaccine: participants will receive one (1) intramuscular injection of 0.5 mL (5 mcg) of Novavax Nuvaxovid. Receives: Biological: COVID-19 vaccine |
| Trajectory B | No intervention | Participants who have already received a 4 doses or more of COVID-19 vaccine in the community at inclusion and do not wish to receive a 5th dose of vaccine in the study. |
| Trajectory B5 | Active comparator | Participants who have received 4 doses of an mRNA vaccine at inclusion and wish to receive a dose of a protein subunit vaccine (PSV) (Novavax NUVAXOVID) as a fifth dose.
For the Novavax Nuvaxovid vaccine: participants will receive one (1) intramuscular injection of 0.5 mL (5 mcg) of Novavax Nuvaxovid. Receives: Biological: COVID-19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of a booster dose of COVID-19 vaccine in patients on anti-CD-20 mAb.
Assessment of SARDs flares (self-reported and physician-confirmed) in relation to the time of the last dose of vaccine received. The frequency of 'significant flares' will be defined as worsening of RA symptoms (i.e., increase in DAS28 >1.2 or >0.6 if DAS28 at baseline was ≥3.2) with an increase in the number of swollen joints confirmed by a rheumatologist that is actionable (requires treatment intensification). For SLE, a flare will be defined as mild/moderate when the index SLEDAI increases by >3 and severe when it increases by >10. The need for treatment intensification (e.g., increase in the dose of steroids) will also be recorded as an indication of SLE flare. For AAV and other SARDs that do not have standard instruments to define flares, we will use the physician's assessment of the presence of a clinically significant flare to the general question " Has this patient experienced a clinically significant flare of their SARD? " and document relevant change in medication.
Measured: 28 days
Reactogenicity of a booster dose of COVID-19 vaccine in patients on anti-CD-20 mAb.
Documentation of the reactogenicity to the booster dose of the vaccine. Reactogenicity post-booster dose will be based on the patient's diary and questionnaire collected at visit 28 days post booster dose vaccination.
Measured: 28 days
Secondary outcomes (1)
Humoral response
We will define vaccine-induced humoral response as a positive (as defined by the cut-off of the assay) serum antibody response against the viral spike RBD protein 28 days post booster dose.
We will measure 1)anti-RBD and anti-N antibodies in all participants at a minimum of three time points using the Héma-Québec assay (Dr Bazin) and 2)neutralization antibodies (NAbs) using the assay developed by Dr Flamand. In addition, we will use a panel of assays developed by Dr Finzi's group including assays to recognized variants of concern and antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) assays.
Measured: 28 days post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start9 Mar 2022
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 287 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul R Fortin
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor-investigator, Paul R Fortin, CHU de Quebec-Universite Laval
- Investigators
- Paul R Fortin, MD,MPH,FRCPC, Principal investigator, Centre de recherche du CHU de Québec - Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236491
- Sponsor's protocol ID
- COVB-2022-1
- Acronym
- COVBIRD
- Status last verified
- Jan 2023
- First submitted
- 10 Feb 2022
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COvid-19 Vaccine Booster in Immunocompromised Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT05236491
- Acronym / sponsor ID
- COVBIRD / COVB-2022-1
- Conditions
- Rheumatoid Arthritis, Autoimmune Rheumatologic Disease, Systemic Lupus Erythematosus, Systemic Vasculitis, Systemic Sclerosis, Scleroderma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 287 participants (estimated)
- Lead sponsor
- Paul R FortinUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 11 Feb 2022 (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.
People living with Systemic autoimmune rheumatic diseases (SARDs) face a new and urgent dilemma: immunosuppression increases risk for worse COVID-19 infection, yet an immune stimulation, such as vaccination, could re-activate their disease. Fear of vaccine-related disease reactivation is not of concern in other immunosuppressed groups (e.g. patients receiving chemotherapy or hemodialysis) but in SARDs, disease flare could lead to organ failure or even death. Specific research in this population is therefore critical. Moreover, among SARD patients, those on anti-CD-20 monoclonal antibody (mAb) (i.e. rituximab (anti-CD-20 mAb)), a medication used to treat inflammatory types of arthritis, have extremely low immunity post-COVID-19 mRNA vaccine. This study will test the hypothesis that a booster dose of a COVID-19 vaccine is safe and enhances post-vaccine humoral and cellular responses in SARDs patients on anti-CD-20 mAb treatment. The magnitude of this response depends on the type of COVID-19 vaccine administered and is optimal when the booster dose is a vaccine from a different group than the one used for primary immunization (mix-and-match approach).
Detailed description
Systemic autoimmune rheumatic diseases (SARDs) include rheumatoid arthritis (RA), systemic lupus (SLE), systemic vasculitis, and related diseases where immune system activity causes widespread inflammation in organs, leading to sickness, organ damage, disability, high health costs, and even death. With no cure, SARDs require life-long immunosuppression. People living with SARDs now face a new and urgent dilemma: immunosuppression increases risk for worse COVID-19 infection, yet an immune stimulation, such as vaccination, could re-activate their disease. Fear of vaccine-related disease reactivation is not of concern in other immunosuppressed groups (e.g. patients receiving chemotherapy or hemodialysis) but in SARDs, disease flare could lead to organ failure or even death. Specific research in this population is therefore critical. Moreover, among SARD patients, those on anti-CD-20 monoclonal antibody (mAb) (i.e. rituximab (anti-CD-20 mAb)) have extremely low humoral immunity post-COVID-19 mRNA vaccine. As of mid-July 2021, 1489 SARDs patients were actively treated with anti-CD-20 mAb in the province of Quebec (personal communication).
This study will test the hypothesis that a booster dose of a COVID-19 vaccine is safe and enhances post-vaccine humoral and cellular responses in SARDs patients on anti-CD-20 mAb treatment. The magnitude of this response depends on the type of COVID-19 vaccine administered and is optimal when the booster dose is a vaccine from a different group than the one used for primary immunization (mix-and-match approach).
Our goal is to recruit 287 adults with SARDs on anti-CD-20 mAb treatment post-three doses of an approved mRNA-COVID-19 vaccine in a non-randomized, open label, comparative clinical trial with pragmatic features. This includes persons with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), inflammatory immune myopathies (IIM), overlap and undifferentiated connective tissue diseases (OCTD and UCTD) and ANCA-associated vasculitis (AAV). We will test at entry all participants for their anti-SARS-CoV-2-spike receptor binding domain (anti-RBD) antibody response to their previous doses of mRNA-COVID-19 vaccines. For participants who have received 3 doses of an mRNA vaccine, we will offer them a choice between a fourth dose of an mRNA (vaccine and a dose of a protein subunit vaccine (PSV). For participants who have already received 4 doses of an mRNA vaccine in the community, they will be offered a dose of a protein subunit vaccine (PSV) as a fifth dose.
The primary study outcome will be the assessment of the safety and reactogenicity of a booster dose of COVID-19 vaccine using a mix-and-match strategy in immunocompromised rheumatic disease patients on an anti-CD-20 mAb. The secondary study outcome will be the humoral responses as measured by the anti-RBD Ab 28 days post vaccination. Exploratory outcomes include the cellular response at 28 days; the delayed humoral responses at 6 months; a comparison of the immunogenicity between types of vaccine (mRNA vs PSV); the evaluation of the effects of concomitant treatments on immunogenicity post-COVID-19 vaccine; the description of the rates of disease flares post booster dose of COVID-19 vaccine; and a description of the decision process for vaccine selection.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trajectory A | Active comparator | Biological: COVID-19 vaccineParticipants who have received 3 doses of an mRNA vaccine, will be offered a choice between a fourth dose of an mRNA vaccine and a dose of a protein subunit vaccine (PSV) (Novavax NUVAXOVID) For the Moderna SPIKEVAX Bivalent Original/Omicron BA.4/5: participants will receive one (1) intramuscular injection of 0.5 mL (50 mcg). For the Novavax Nuvaxovid vaccine: participants will receive one (1) intramuscular injection of 0.5 mL (5 mcg) of Novavax Nuvaxovid. |
| Trajectory B | No intervention | –Participants who have already received a 4 doses or more of COVID-19 vaccine in the community at inclusion and do not wish to receive a 5th dose of vaccine in the study. |
| Trajectory B5 | Active comparator | Biological: COVID-19 vaccineParticipants who have received 4 doses of an mRNA vaccine at inclusion and wish to receive a dose of a protein subunit vaccine (PSV) (Novavax NUVAXOVID) as a fifth dose. For the Novavax Nuvaxovid vaccine: participants will receive one (1) intramuscular injection of 0.5 mL (5 mcg) of Novavax Nuvaxovid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of a SARD (Rheumatoid arthritis, systemic lupus erythematosus (SLE), juvenile inflammatory arthritis, systemic sclerosis (SSc), idiopathic inflammatory myositis (IIM), overlap connective tissue diseases, mixed connective tissue disease, undifferentiated connective tissue diseases, giant-cell arteritis, and the ANCA-Associated Vasculitis: granulomatosis with polyangiitis (GPA; formerly known as Wegener's granulomatosis), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA; previously known as Churg-Strauss syndrome);
- Has received 3 or more doses of an mRNA vaccine;
- Age 18 years and older;
- Male or non-pregnant female;
- Rituximab treatment within last 12 months;
Key exclusion criteria (5 listed)
- Any medical disease or condition that, in the opinion of the site Principal Investigator or sub-investigator, precludes study participation;
- Significant behavioral disturbances;
- Previous diagnosis of hepatitis B, hepatitis C or HIV;
- History of hypersensitivity or severe allergic reaction such as anaphylaxis to a component of the vaccine or to a previous vaccine;
- People who experienced inflammation of the heart or lining of the heart (myocarditis or pericarditis) after a previous dose of an mRNA vaccine or protein subunit vaccine.
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 |
|---|---|---|
| COVID-19 vaccineParticipants are to receive a booster dose of a COVID-19 vaccine. | Biological | Trajectory A, Trajectory B5 |
Primary outcome
Safety of a booster dose of COVID-19 vaccine in patients on anti-CD-20 mAb.
Time frame: 28 days
Assessment of SARDs flares (self-reported and physician-confirmed) in relation to the time of the last dose of vaccine received. The frequency of 'significant flares' will be defined as worsening of RA symptoms (i.e., increase in DAS28 >1.2 or >0.6 if DAS28 at baseline was ≥3.2) with an increase in the number of swollen joints confirmed by a rheumatologist that is actionable (requires treatment intensification). For SLE, a flare will be defined as mild/moderate when the index SLEDAI increases by >3 and severe when it increases by >10. The need for treatment intensification (e.g., increase in the dose of steroids) will also be recorded as an indication of SLE flare. For AAV and other SARDs that do not have standard instruments to define flares, we will use the physician's assessment of the presence of a clinically significant flare to the general question " Has this patient experienced a clinically significant flare of their SARD? " and document relevant change in medication.
Reactogenicity of a booster dose of COVID-19 vaccine in patients on anti-CD-20 mAb.
Time frame: 28 days
Documentation of the reactogenicity to the booster dose of the vaccine. Reactogenicity post-booster dose will be based on the patient's diary and questionnaire collected at visit 28 days post booster dose vaccination.
1 secondary outcome
Humoral response
Time frame: 28 days post vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- 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.
Paul R Fortin, MD,MPH,FRCPC principal investigator
Centre de recherche du CHU de Québec - Université Laval
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing COVID-19 vaccine in people with Rheumatoid Arthritis and Autoimmune Rheumatologic Disease, run by Paul R Fortin at 2 sites 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Jan 2023. 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 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul R Fortin, MD,MPH,FRCPC (4185254444 ext. 48456, paul.fortin@crchudequebec.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of a booster dose of COVID-19 vaccine in patients on anti-CD-20 mAb. (time frame: 28 days). The study lists 2 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 17 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.