Long COVIDCov-N-PsyNCT06279936
Neurobiological Underpinnings of Neuropsychological Consequences in Long COVID
An observational study of Long COVID, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
Objectives: To describe the standardized evaluation of the psychological and cognitive function of long COVID patients and their evolution, to compare immunological and HPA-axis related biomarkers between long COVID patients and healthy controls, to explore cross-sectional and longitudinal associations between… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Long COVID
- What is being tested?
- Neuropsychological battery, Surveys and symptom severity questionnaires and Blood withdrawal
- How many people
- 130 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2021to 31 Dec 2024
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Three participant groups will be included: 1) long COVID patients with neuropsychological complaints (P), 2) COVID-survivors without persistent complaints (Ca) and 3) healthy volunteers (Cb).
Who may be able to join
- 18-70 years
- Diagnosis of long COVID
- (Neuro)psychological symptoms >4 weeks after infection
- Infection with SARS-Cov-2 was detected with PCR (or antigen test)
- Other causes for their complaints are excluded by their GP or specialist
- Positive score on at least 2 NP domains during the screening phase
Show all 14Show fewer
- 18-70 years
- No prolonged symptoms due to SARS-CoV-2 infection within 4 weeks after infection
- No current (Neuro)psychological symptoms
- Infection with SARS-Cov-2 was detected with PCR (or antigen test)
- A positive score on maximum one domain (psychological / cognitive) is allowed in the absence of a psychiatric diagnosis (confirmed by the MINI) and when the complaint causes significant distress (which is investigated during the screening phase).
- 18-70 years
- No (known) infection with SARS-CoV-2
- No current or previous (neuro)psychological symptoms
Who cannot join
- General exclusion criteria:
- Participant is unable to read and understand the consent form and patient-reported outcomes, complete study-related procedures, or communicate with the study staff and informed consent cannot realistically be obtained in retrospect or with the help of a competent family member or legal representative.
- HPA subgroup
- Participant is pregnant or breastfeeding
- Participant receives hormonal replacement therapy (contraception is allowed).
- Participant is treated with cortisol <4 weeks ago
Show all 14Show fewer
- Neurocognitive assessment:
- IQ < 90 (screened with Raven Standard Progressive Matrices (Short Form) (RSPM-SF) (39)
- Participant takes sedative medication
- Benzodiazepines: Larger than the equivalent of diazepam 10mg per day. Last administration <8 hours prior to the neurocognitive tests.
- New sedative antipsychotics/antidepressants (<4 weeks)
- Other medication from DRUID class III (<4 weeks), last administration <8 hours prior to the neurocognitive tests, or causing significant sedation.
- Severe substance abuse (alcohol + drugs)
- Pre-existing neurological diseases that influence cognitive functioning
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurobiological Underpinnings of Neuropsychological Consequences in Long COVID: Exploration of Two Translational Pathways
Objectives:
To describe the standardized evaluation of the psychological and cognitive function of long COVID patients and their evolution, to compare immunological and HPA-axis related biomarkers between long COVID patients and healthy controls, to explore cross-sectional and longitudinal associations between immunological measures and long COVID symptoms.
Read more
Study design:
Cov-N-Psy is a longitudinal observational study. Three groups will be included from 2021 until 2023: long COVID patients with neuropsychological complaints (P), COVID-survivors without persistent complaints (Ca) and healthy volunteers without a history of COVID-19 (Cb). The total sample size is estimated on 130. Four visits are organized: at baseline, three, six and twelve months.
The study is organized in three work packages (WP). WP1 includes a blood withdrawal and psychometric questionnaires and is part of every visit. WP2 includes cortisol measurement in saliva and takes place on the baseline visit for every participant and on the third visit for patients. Finally, WP3 includes a neurocognitive assessment at baseline for patients and Ca controls and on the third visit for patients.
Read the detailed description
Research Objectives
Describe the standardized evaluation of the psychopathological and neurocognitive function of long COVID NP patients and their evolution over time; Compare the immunological profile and the cortisol awakening response (CAR) of long COVID NP patients to those of COVID-19 survivors without persistent complaints and healthy uninfected controls; Explore the cross-sectional and longitudinal association between long COVID NP symptoms and immunological and cortisol measures.
Methodology
Recruitment and study population
Inclusion criteria - patients:
All patients 18-70 years referred to the University Psychiatric Hospital (Campus UZA and Campus Duffel) for psychological and/or cognitive complaints at least >4 weeks following a confirmed diagnosis of COVID-19 infection with a positive PCR test or an antibodies test will be invited to participate in the study. The sample size of the patients is estimated on 50 participants. The patients have to be examined by their treating physician before enrollment to make sure other medical causes for their complaints are excluded. A positive score on at least two domains (psychological /cognitive) is necessary during the screening phase.
Inclusion criteria - controls:
Two control groups, one of 30 healthy uninfected controls (Cb), another of 50 COVID-19 survivors without persistent complaints (Ca), matched on age, sex and education with the patient group will be included. The participants for Ca will be recruited in UZA and by advertising. The healthy controls (Cb) will be recruited by mailing within the hospital and by advertising. A positive score on maximum one domain (psychological / cognitive) is allowed in the absence of a psychiatric diagnosis (confirmed by the MINI) and when the complaint causes significant distress (which is investigated during the screening phase).
Exclusion criteria for each subgroup:
- HPA subgroup: Participant is pregnant or breastfeeding / Participant receives hormonal replacement therapy (contraception is allowed) /Participant is treated with cortisol <4 weeks ago
- Neurocognitive assessment: IQ < 90 (screened with Raven Standard Progressive Matrices (Short Form) (RSPM-SF) / Participant takes sedative medication: benzodiazepines (Larger than the equivalent of diazepam 10mg per day, Last administration <8 hours prior to the neurocognitive test), new sedative antipsychotics/antidepressants (<4 weeks), other medication from DRUID class III (<4 weeks), last administration <8 hours prior to the neurocognitive tests, or causing significant sedation / Severe substance abuse (alcohol + drugs) / Pre-existing neurological diseases causing cognitive problems.
Study design This is a longitudinal study, which will be organized into three work packages (WP1, WP2 and WP3). Enrollment will continue for an estimated period of 24 months, depending on the time course of the epidemic curve. Last-patient-in is expected no later than November 1st, 2023. Patients will be referred mainly by the University Hospital of Antwerp (UZA) and enrolled at first visit to the University Psychiatric Hospital (UPCD), where follow-up will also take place at 3, 6 and 12 months. Patients can also be referred by the Flemish long COVID patient support group.
WP1 includes a blood withdrawal and psychometric questionnaires and is part of every visit. WP2 includes cortisol measurement in saliva and takes place on the baseline visit for every participant and on the third visit for patients. Finally, WP3 includes a neurocognitive assessment at baseline for patients and Ca controls and on the third visit for patients.
- Conditions
- Long COVID
- Being tested
- Neuropsychological battery, Surveys and symptom severity questionnaires, Blood withdrawal, Saliva swabs
- Keywords
- brain fog, neuropsychological, depression, anxiety, immunological markers, cortisol
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Mental Fatigue, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological batteryOther
COVID-19 patients with persistent complaints of cognitive disabilities (more than 4 weeks post-infection) in daily life are examined with an extensive neuropsychological test battery (see below) at the outpatient clinic of the University Psychiatric Centre in Duffel and at the University Hospital Antwerp. This battery covers a broad range of reliable and valid tests divided into six cognitive domains: attention, memory, visuospatial functions, language, executive functions and psychomotor speed/coordination. The neuropsychological examination lasts an average of 2 hours per participant. The tests are carried out by the same experienced neuropsychologist and also follow a standardized sequence. In addition to the neuropsychological assessment, two self-report scales are filled out by each patient. These scales are used to detect possible complaints of fatigue and possible cognitive problems which are experienced by the patient during daily life activities.
Surveys and symptom severity questionnairesOther
Both self-rated surveys and clinician administered questionnaires
Blood withdrawalOther
Blood samples will be collected in a standardized manner by venipuncture. Two blood vials will be collected and processed to perform the following analyses:
- serum collection tube(s) allowing for HERV-W ENV and serological assays
- plasma collection tubes for the assessment of other immune-related biomarkers (including but not limited to CRP, IL-6, IL-1b, TNF-a, IFN-g, tryptophan, kynurenine, 3-OH-kynurenine, quinolinic acid, kynurenic acid, enzymes of the kynurenine pathway).
Saliva swabsOther
Salivary cortisol measures will be used as functional measure of the HPA axis activity, as the unbound cortisol fraction in saliva is highly correlated to plasma cortisol. Baseline diurnal cortisol and CAR levels will be measured using saliva, collected at home with Salivette® (Sarstedt) synthetic swabs. The rationale behind the choice of home sampling, is to maximize normal circumstances and to minimize stress related to the measuring procedure.
| Study group | Role | What they receive |
|---|---|---|
| Long Covid patients | Long Covid patients with (neuro)psychological complaints Receives: Other: Neuropsychological battery; Other: Surveys and symptom severity questionnaires; Other: Blood withdrawal; Other: Saliva swabs | |
| Covid controls (Ca) | COVID-19 survivors without persistent complaints Receives: Other: Neuropsychological battery; Other: Surveys and symptom severity questionnaires; Other: Blood withdrawal; Other: Saliva swabs | |
| Non-Covid controls (Cb) | healthy uninfected controls Receives: Other: Surveys and symptom severity questionnaires; Other: Blood withdrawal; Other: Saliva swabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of immunological and HPA-axis markers
Compare the immunological profile and the cortisol awakening response (CAR) of long COVID NP patients to those of COVID-19 survivors without persistent complaints and healthy uninfected controls
Measured: Baseline (11/2021-12/2023) - FU (01/2022-12/2024)
Secondary outcomes (2)
Rate of psychopathological and neurocognitive function of long COVID patients with neuropsychiatric complaints
Describe the standardized evaluation of the psychopathological and neurocognitive function of long COVID NP patients and their evolution over time;
Measured: Baseline (11/2021-12/2023) - FU (01/2022-12/2024)
Cross-sectional and longitudinal association between long COVID NP symptoms (BDI, HDRS, STAI, ISI, KEDS, FSS, NP battery ...) and immunological and cortisol measures (CAR, cytokines, serology, WBC, CRP, mitochondrial markers, TRYCATS, ...)
Measured: Baseline (11/2021-12/2023) - FU (01/2022-12/2024)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Nov 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies 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
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- UZA Foundation
- Responsible party
- Principal investigator, Dr Livia De Picker, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279936
- Sponsor's protocol ID
- B3002021000171
- Acronym
- Cov-N-Psy
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiological Underpinnings of Neuropsychological Consequences in Long COVID: Exploration of Two Translational Pathways
- ClinicalTrials.gov ID
- NCT06279936
- Acronym / sponsor ID
- Cov-N-Psy / B3002021000171
- Conditions
- Long COVID
- Keywords
- brain fog, neuropsychological, depression, anxiety, immunological markers, cortisol
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- UZA Foundation
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Feb 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.
Objectives:
To describe the standardized evaluation of the psychological and cognitive function of long COVID patients and their evolution, to compare immunological and HPA-axis related biomarkers between long COVID patients and healthy controls, to explore cross-sectional and longitudinal associations between immunological measures and long COVID symptoms.
Study design:
Cov-N-Psy is a longitudinal observational study. Three groups will be included from 2021 until 2023: long COVID patients with neuropsychological complaints (P), COVID-survivors without persistent complaints (Ca) and healthy volunteers without a history of COVID-19 (Cb). The total sample size is estimated on 130. Four visits are organized: at baseline, three, six and twelve months.
The study is organized in three work packages (WP). WP1 includes a blood withdrawal and psychometric questionnaires and is part of every visit. WP2 includes cortisol measurement in saliva and takes place on the baseline visit for every participant and on the third visit for patients. Finally, WP3 includes a neurocognitive assessment at baseline for patients and Ca controls and on the third visit for patients.
Detailed description
Research Objectives
Describe the standardized evaluation of the psychopathological and neurocognitive function of long COVID NP patients and their evolution over time; Compare the immunological profile and the cortisol awakening response (CAR) of long COVID NP patients to those of COVID-19 survivors without persistent complaints and healthy uninfected controls; Explore the cross-sectional and longitudinal association between long COVID NP symptoms and immunological and cortisol measures.
Methodology
Recruitment and study population
Inclusion criteria - patients:
All patients 18-70 years referred to the University Psychiatric Hospital (Campus UZA and Campus Duffel) for psychological and/or cognitive complaints at least >4 weeks following a confirmed diagnosis of COVID-19 infection with a positive PCR test or an antibodies test will be invited to participate in the study. The sample size of the patients is estimated on 50 participants. The patients have to be examined by their treating physician before enrollment to make sure other medical causes for their complaints are excluded. A positive score on at least two domains (psychological /cognitive) is necessary during the screening phase.
Inclusion criteria - controls:
Two control groups, one of 30 healthy uninfected controls (Cb), another of 50 COVID-19 survivors without persistent complaints (Ca), matched on age, sex and education with the patient group will be included. The participants for Ca will be recruited in UZA and by advertising. The healthy controls (Cb) will be recruited by mailing within the hospital and by advertising. A positive score on maximum one domain (psychological / cognitive) is allowed in the absence of a psychiatric diagnosis (confirmed by the MINI) and when the complaint causes significant distress (which is investigated during the screening phase).
Exclusion criteria for each subgroup:
- HPA subgroup: Participant is pregnant or breastfeeding / Participant receives hormonal replacement therapy (contraception is allowed) /Participant is treated with cortisol <4 weeks ago
- Neurocognitive assessment: IQ < 90 (screened with Raven Standard Progressive Matrices (Short Form) (RSPM-SF) / Participant takes sedative medication: benzodiazepines (Larger than the equivalent of diazepam 10mg per day, Last administration <8 hours prior to the neurocognitive test), new sedative antipsychotics/antidepressants (<4 weeks), other medication from DRUID class III (<4 weeks), last administration <8 hours prior to the neurocognitive tests, or causing significant sedation / Severe substance abuse (alcohol + drugs) / Pre-existing neurological diseases causing cognitive problems.
Study design This is a longitudinal study, which will be organized into three work packages (WP1, WP2 and WP3). Enrollment will continue for an estimated period of 24 months, depending on the time course of the epidemic curve. Last-patient-in is expected no later than November 1st, 2023. Patients will be referred mainly by the University Hospital of Antwerp (UZA) and enrolled at first visit to the University Psychiatric Hospital (UPCD), where follow-up will also take place at 3, 6 and 12 months. Patients can also be referred by the Flemish long COVID patient support group.
WP1 includes a blood withdrawal and psychometric questionnaires and is part of every visit. WP2 includes cortisol measurement in saliva and takes place on the baseline visit for every participant and on the third visit for patients. Finally, WP3 includes a neurocognitive assessment at baseline for patients and Ca controls and on the third visit for patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Long Covid patients | – | Other: Neuropsychological battery, Other: Surveys and symptom severity questionnaires, Other: Blood withdrawal, Other: Saliva swabsLong Covid patients with (neuro)psychological complaints |
| Covid controls (Ca) | – | Other: Neuropsychological battery, Other: Surveys and symptom severity questionnaires, Other: Blood withdrawal, Other: Saliva swabsCOVID-19 survivors without persistent complaints |
| Non-Covid controls (Cb) | – | Other: Surveys and symptom severity questionnaires, Other: Blood withdrawal, Other: Saliva swabshealthy uninfected controls |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Three participant groups will be included: 1) long COVID patients with neuropsychological complaints (P), 2) COVID-survivors without persistent complaints (Ca) and 3) healthy volunteers (Cb).
Key inclusion criteria (14 listed)
- 18-70 years
- Diagnosis of long COVID
- (Neuro)psychological symptoms >4 weeks after infection
- Infection with SARS-Cov-2 was detected with PCR (or antigen test)
- Other causes for their complaints are excluded by their GP or specialist
Key exclusion criteria (14 listed)
- General exclusion criteria:
- Participant is unable to read and understand the consent form and patient-reported outcomes, complete study-related procedures, or communicate with the study staff and informed consent cannot realistically be obtained in retrospect or with the help of a competent family member or legal representative.
- HPA subgroup
- Neurocognitive assessment:
- Benzodiazepines: Larger than the equivalent of diazepam 10mg per day. Last administration <8 hours prior to the neurocognitive tests.
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 |
|---|---|---|
| Neuropsychological batteryCOVID-19 patients with persistent complaints of cognitive disabilities (more than 4 weeks post-infection) in daily life are examined with an extensive neuropsychological test battery (see below) at the outpatient clinic of the University Psychiatric Centre in Duffel and at the University Hospital Antwerp. This battery covers a broad range of reliable and valid tests divided into six cognitive domains: attention, memory, visuospatial functions, language, executive functions and psychomotor speed/coordination. The neuropsychological examination lasts an average of 2 hours per participant. The tests are carried out by the same experienced neuropsychologist and also follow a standardized sequence. In addition to the neuropsychological assessment, two self-report scales are filled out by each patient. These scales are used to detect possible complaints of fatigue and possible cognitive problems which are experienced by the patient during daily life activities. | Other | Covid controls (Ca), Long Covid patients |
| Surveys and symptom severity questionnairesBoth self-rated surveys and clinician administered questionnaires | Other | Covid controls (Ca), Long Covid patients, Non-Covid controls (Cb) |
| Blood withdrawalBlood samples will be collected in a standardized manner by venipuncture. Two blood vials will be collected and processed to perform the following analyses: * serum collection tube(s) allowing for HERV-W ENV and serological assays * plasma collection tubes for the assessment of other immune-related biomarkers (including but not limited to CRP, IL-6, IL-1b, TNF-a, IFN-g, tryptophan, kynurenine, 3-OH-kynurenine, quinolinic acid, kynurenic acid, enzymes of the kynurenine pathway). | Other | Covid controls (Ca), Long Covid patients, Non-Covid controls (Cb) |
| Saliva swabsSalivary cortisol measures will be used as functional measure of the HPA axis activity, as the unbound cortisol fraction in saliva is highly correlated to plasma cortisol. Baseline diurnal cortisol and CAR levels will be measured using saliva, collected at home with Salivette® (Sarstedt) synthetic swabs. The rationale behind the choice of home sampling, is to maximize normal circumstances and to minimize stress related to the measuring procedure. | Other | Covid controls (Ca), Long Covid patients, Non-Covid controls (Cb) |
Primary outcome
Concentration of immunological and HPA-axis markers
Time frame: Baseline (11/2021-12/2023) - FU (01/2022-12/2024)
Compare the immunological profile and the cortisol awakening response (CAR) of long COVID NP patients to those of COVID-19 survivors without persistent complaints and healthy uninfected controls
2 secondary outcomes
Rate of psychopathological and neurocognitive function of long COVID patients with neuropsychiatric complaints
Time frame: Baseline (11/2021-12/2023) - FU (01/2022-12/2024)
Cross-sectional and longitudinal association between long COVID NP symptoms (BDI, HDRS, STAI, ISI, KEDS, FSS, NP battery ...) and immunological and cortisol measures (CAR, cytokines, serology, WBC, CRP, mitochondrial markers, TRYCATS, ...)
Time frame: Baseline (11/2021-12/2023) - FU (01/2022-12/2024)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Long COVID
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Not yet recruitingPhase 3
Dapagliflozin for Long COVID Syndrome
COVID - 19, Long COVID Syndrome
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
RecruitingPhase 2
SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction
Post-acute Sequelae of COVID-19, Long COVID
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Long COVID, run by Universiteit Antwerpen at 1 site in Belgium.
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 14 inclusion and 14 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 28 Feb 2024. 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 Belgium. 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?
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?
Concentration of immunological and HPA-axis markers (time frame: Baseline (11/2021-12/2023) - FU (01/2022-12/2024)). 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 28 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.