Coronavirus InfectionPhase 2CoronavirusNCT04349098
Evaluation of Activity and Safety of Oral Selinexor in Participants With Severe COVID-19 Infection
A Phase 2 study testing Selinexor in people with Coronavirus Infection, run by Karyopharm Therapeutics Inc at 33 sites in 6 countries.
Trial summary
The main purpose of this study is to evaluate the activity of low dose oral selinexor (KPT-330) and to evaluate the clinical recovery, the viral load, length of hospitalization and the rate of morbidity and mortality in participants with severe COVID-19 compared to placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infection
- What is being tested?
- Selinexor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 33 sitesin 6 countries
- Study dates
- 17 Apr 2020to 5 Oct 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Confirmed laboratory diagnosis of SARS-CoV2 by standard FDA-approved reverse transcription polymerase chain reaction (RT-PCR) assay or equivalent FDA-approved testing (local labs).
- Currently hospitalized.
- Informed consent provided as above (it is recommended that participants are dosed with study drug within 12 hours of consent).
- Has symptoms of severe COVID-19 as demonstrated by:
- At least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress.
- Clinical signs indicative of lower respiratory infection with COVID-19, with at least one of the following: SaO2 <92% on room air in last 12 hours or requires > 4 liters per minute (LPM) oxygen by nasal canula, non-rebreather/Ventimask or high flow nasal canula in order maintain SaO2 ≥92%, PaO2/FiO2 <300 millimeter per mercury (mm/hg).
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- Elevated C-reactive protein (CRP) > 2 x upper limit of normal (ULN).
- Concurrent anti-viral and/or anti-inflammatory agents (e.g., biologics, hydroxychloroquine) are permitted. If in the physician's judgment, it is in the best interest of the participant to use anti-viral or anti-inflammatory treatments, these treatments are to be documented in the participant's chart and entered in the electronic case report form.
- Female participants of childbearing potential must have a negative serum pregnancy test at Screening. Female participants of childbearing potential and fertile male participants must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.
Who cannot join
- Evidence of critical COVID-19 based on:
- Respiratory failure (defined by endotracheal intubation and mechanical ventilation, oxygen delivered by noninvasive positive pressure ventilation, or clinical diagnosis of respiratory failure in setting of resource limitations)
- Septic shock (defined by Systolic blood pressure [BP] < 90 mm Hg, or Diastolic BP < 60 mm Hg)
- Multiple organ dysfunction/failure
- In the opinion of the investigator, unlikely to survive for at least 48 hours from screening or anticipate mechanical ventilation within 48 hours.
- Inadequate hematologic parameters as indicated by the following labs:
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- Participants with severe neutropenia (ANC <1000 x 10^9/L) or
- Thrombocytopenia (e.g., platelets <100,000 per microliter of blood)
- Inadequate renal and liver function as indicated by the following labs:
- Creatinine clearance (CrCL) <20 mL/min using the formula of Cockcroft and Gault
- Aspartate transaminase (AST) or alanine transaminase (ALT) > 5 x ULN
- Hyponatremia defined as sodium < 135 milliequivalents per liter (mEq/L).
- Unable to take oral medication when informed consent is obtained.
- Participants with a legal guardian or who are incarcerated.
- Treatment with strong CYP3A inhibitors or inducers.
- Pregnant and breastfeeding women.
Trial locations and contacts
33 sites in 6 countries.
33 sites in 6 countries
United States20 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Emory University
Atlanta, Georgia, 30322
Boston Medical Center
Boston, Massachusetts, 02118
Levine Cancer Institute-Atrium Health University City
Charlotte, North Carolina, 28204
Baylor Scott & White Dallas
Dallas, Texas, 75201
Karmanos
Detroit, Michigan, 48201
Michigan Center of Medical Research
Farmington Hills, Michigan, 48336
University of Kansas Medical Center
Kansas City, Kansas, 64113
UCLA
Los Angeles, California, 90095
Norton Healthcare
Louisville, Kentucky, 40202
Miami Cancer Institute at Baptist Health
Miami, Florida, 33176
Columbia University
New York, New York, 10032
Weill Cornell Medical College
New York, New York, 10065
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Kaiser Permanente Oakland
Oakland, California, 94612
Michigan Center of Medical Research
Royal Oak, Michigan, 48073
UC Davis Health
Sacramento, California, 95817
Kaiser Permanente Sacramento
Sacramento, California, 95825
Kaiser Permanente San Francisco
San Francisco, California, 94115
MultiCare Institute for Research & Innovation (Puget Sound)
Tacoma, Washington, 98405
United Kingdom4 sites
Princess Royal University Hospital
Kent, BR6 8ND
Kings College Hospital
London, SE5 9RS
The Royal Marsden Hospital
London, SW3 6JJ
University Hospitals Plymouth NHS Trust
Plymouth, PL6 5FP
France3 sites
CHU Bordeaux
Bordeaux, 33076
CHU Lyon
Lyon, 69004
CHU Nantes
Nantes, 44093
Israel3 sites
Hadassah MC
Jerusalem
Hasharon Medical Center
Petah Tikva
Sheba Medical Center
Tel HaShomer
Spain2 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Servicio de Medicina Interna, Hospital Universitario de Salamanca, Universidad de Salamanca
Salamanca, 37007
Austria1 site
Hospital Hietzing, 2. Medical department - Center for Diagnosis and Therapy of Rheumatic Diseases
Vienna
About this study
Official title: A Phase 2 Randomized Single-Blind Study to Evaluate the Activity and Safety of Low Dose Oral Selinexor (KPT-330) in Patients With Severe COVID-19 Infection
The main purpose of this study is to evaluate the activity of low dose oral selinexor (KPT-330) and to evaluate the clinical recovery, the viral load, length of hospitalization and the rate of morbidity and mortality in participants with severe COVID-19 compared to placebo. The study had 2 arms and evaluated selinexor 20 mg + standard of care (SoC) and placebo + SoC. As the treatment for COVID-19 is rapidly evolving, the SoC varied over time and across regions of the world.
- Conditions
- Coronavirus Infection
- Being tested
- Selinexor, Placebo
- Keywords
- COVID-19, SARS-CoV-2
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelinexorDrug
Also called KPT-330, XPOVIO
Participants will receive 20 mg of selinexor.
PlaceboOther
Participants will receive 20 mg of placebo matched to selinexor.
| Study group | Role | What they receive |
|---|---|---|
| Selinexor 20 mg | Experimental | Participants will receive 20 milligram (mg) of selinexor oral tablet on Days 1, 3, and 5 of each week for up to 2 weeks (14 days). If the participant is tolerating therapy and clinically benefitting, dosing can continue for an additional 2 weeks (28 days). Receives: Drug: Selinexor |
| Placebo | Placebo comparator | Participants will receive 20 mg of placebo matched to selinexor oral tablet on Days 1, 3, and 5 of each week for up to 2 weeks (14 days). If the participant is tolerating therapy and clinically benefitting, dosing can continue for an additional 2 weeks (28 days). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With At-least a 2-Point Improvement in Ordinal Scale
Ordinal Scale 2-Point improvement was defined as percentage of participants with at least a 2-points improvement (increase from baseline) by Day 14. Baseline score was defined as the last score measured before first dosing. The 8-point ordinal scale ranges from 1 to 8: where 1= death, 2= hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3= hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5= hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (coronavirus disease 2019 [COVID-19] related or otherwise); 6= hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7= not hospitalized, limitation on activities and/or requiring home oxygen; 8= not hospitalized, no limitations on activities.
Measured: Baseline up to Day 14
Secondary outcomes (12)
Percentage of Participants With at Least a 2-Point Improvement in the Ordinal Scale up to Day 7
Ordinal Scale 2-points improvement was defined as percentage of participants with at least a 2-points improvement (increase from baseline) by Day 7. Baseline score was defined as the last score measured before first dosing. The 8-point ordinal scale ranges from 1 to 8: where, 1= death, 2= hospitalized, on invasive mechanical ventilation or ECMO; 3= hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5= hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6= hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7= not hospitalized, limitation on activities and/or requiring home oxygen; 8= not hospitalized, no limitations on activities.
Measured: Baseline up to Day 7
Percentage of Participants With at Least a 1-Point Improvement in the Ordinal Scale
Ordinal Scale 1-point improvement was defined as percentage of participants with at least 1-point improvement (increase from baseline) by Day 7 and 14. Baseline score was defined as the last score measured before first dosing. The 8-point ordinal scale ranges from 1 to 8: where 1= death, 2= hospitalized, on invasive mechanical ventilation or ECMO; 3= hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5= hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6= hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7= not hospitalized, limitation on activities and/or requiring home oxygen; 8= not hospitalized, no limitations on activities.
Measured: Baseline up to Day 7 and 14
Time to Clinical Improvement of 2-points Using Ordinal Scale (TTCI-2)
TTCI-2 was defined as the time from randomization to an improvement of 2-points using 8-points Ordinal Scale. The 8-point ordinal scale ranges from 1 to 8: where 1= death, 2= hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3= hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5= hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (coronavirus disease 2019 [COVID-19] related or otherwise); 6= hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7= not hospitalized, limitation on activities and/or requiring home oxygen; 8= not hospitalized, no limitations on activities.
Measured: Baseline up to Day 28
Overall Death Rate
Overall death rate was defined as the percentage of participants who died on or before Day 28.
Measured: Baseline up to Day 28
Rate of Mechanical Ventilation (RMV)
The rate of RMV was defined as the percentage of participants who ever used invasive mechanical ventilation or ECMO during the hospital stay.
Measured: Baseline up to Day 28
Rate of Intensive Care Unit (ICU) Admission
The rate of ICU admission was defined as the percentage of participants with ICU admissions.
Measured: Baseline up to Day 28
Length of Hospitalization
Length of hospitalization (days) was defined as (first hospital discharge date - date of randomization + 1).
Measured: Baseline up to Day 67
Change From Baseline in C-reactive Protein (CRP) Levels
The anti-inflammatory and immune effects of selinexor were assessed by CRP levels. Baseline was defined as the most recent non-missing measurement prior to the first administration of study treatment. Change from Baseline at the indicated time points was calculated as the value at the indicated time points minus the value at Baseline.
Measured: Baseline, Day 3, 5, 8, 12, 15, 19, 22 and 26
Change From Baseline in Ferritin Levels
The anti-inflammatory and immune effects of selinexor were assessed by ferritin levels. Baseline was defined as the most recent non-missing measurement prior to the first administration of study treatment. Change from Baseline at the indicated time points was calculated as the value at the indicated time points minus the value at Baseline.
Measured: Baseline, Day 3, 5, 8, 12, 15, 19, 22 and 26
Change From Baseline in Lactate Dehydrogenase (LDH) Levels
The anti-inflammatory and immune effects of selinexor were assessed by LDH levels. Baseline was defined as the most recent non-missing measurement prior to the first administration of study treatment. Change from Baseline at the indicated time points was calculated as the value at the indicated time points minus the value at Baseline.
Measured: Baseline, Day 3, 5, 8, 12, 15, 19, 22 and 26
Changes From Baseline in Blood Plasma Cytokines Levels-Interleukin-6 (IL-6)
The anti-inflammatory and immune effects of selinexor were assessed by blood plasma cytokines like IL-6. Baseline was defined as the most recent non-missing measurement prior to the first administration of study treatment. Change from Baseline at the indicated time points was calculated as the value at the indicated time points minus the value at Baseline.
Measured: Baseline, Day 3, 5, 8, 12, 15, 22 and 26
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Adverse events are defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs are defined as those AEs that develop or worsen after the first dose of study drug. TEAEs included both Serious and non-serious TEAEs.
Measured: From start of study drug administration up to Day 58
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start17 Apr 2020
- Primary completion5 Oct 2020
- Study completion5 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronavirus InfectionStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karyopharm Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349098
- Sponsor's protocol ID
- XPORT-CoV-1001
- Other IDs
- 2020-001411-25
- Acronym
- Coronavirus
- Status last verified
- Jan 2023
- First submitted
- 14 Apr 2020
- Last updated
- 20 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized Single-Blind Study to Evaluate the Activity and Safety of Low Dose Oral Selinexor (KPT-330) in Patients With Severe COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04349098
- Acronym / sponsor ID
- Coronavirus / XPORT-CoV-1001
- Conditions
- Coronavirus Infection
- Keywords
- COVID-19, SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Karyopharm Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 5 Oct 2020 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Posted 1 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the activity of low dose oral selinexor (KPT-330) and to evaluate the clinical recovery, the viral load, length of hospitalization and the rate of morbidity and mortality in participants with severe COVID-19 compared to placebo. The study had 2 arms and evaluated selinexor 20 mg + standard of care (SoC) and placebo + SoC. As the treatment for COVID-19 is rapidly evolving, the SoC varied over time and across regions of the world.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selinexor 20 mg | Experimental | Drug: SelinexorParticipants will receive 20 milligram (mg) of selinexor oral tablet on Days 1, 3, and 5 of each week for up to 2 weeks (14 days). If the participant is tolerating therapy and clinically benefitting, dosing can continue for an additional 2 weeks (28 days). |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive 20 mg of placebo matched to selinexor oral tablet on Days 1, 3, and 5 of each week for up to 2 weeks (14 days). If the participant is tolerating therapy and clinically benefitting, dosing can continue for an additional 2 weeks (28 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Confirmed laboratory diagnosis of SARS-CoV2 by standard FDA-approved reverse transcription polymerase chain reaction (RT-PCR) assay or equivalent FDA-approved testing (local labs).
- Currently hospitalized.
- Informed consent provided as above (it is recommended that participants are dosed with study drug within 12 hours of consent).
- Has symptoms of severe COVID-19 as demonstrated by:
- Elevated C-reactive protein (CRP) > 2 x upper limit of normal (ULN).
Key exclusion criteria (16 listed)
- Evidence of critical COVID-19 based on:
- In the opinion of the investigator, unlikely to survive for at least 48 hours from screening or anticipate mechanical ventilation within 48 hours.
- Inadequate hematologic parameters as indicated by the following labs:
- Inadequate renal and liver function as indicated by the following labs:
- Hyponatremia defined as sodium < 135 milliequivalents per liter (mEq/L).
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 |
|---|---|---|
| SelinexorAlso: KPT-330, XPOVIOParticipants will receive 20 mg of selinexor. | Drug | Selinexor 20 mg |
| PlaceboParticipants will receive 20 mg of placebo matched to selinexor. | Other | Placebo |
Primary outcome
Percentage of Participants With At-least a 2-Point Improvement in Ordinal Scale
Time frame: Baseline up to Day 14
Ordinal Scale 2-Point improvement was defined as percentage of participants with at least a 2-points improvement (increase from baseline) by Day 14. Baseline score was defined as the last score measured before first dosing. The 8-point ordinal scale ranges from 1 to 8: where 1= death, 2= hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3= hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5= hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (coronavirus disease 2019 [COVID-19] related or otherwise); 6= hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7= not hospitalized, limitation on activities and/or requiring home oxygen; 8= not hospitalized, no limitations on activities.
12 secondary outcomes
Percentage of Participants With at Least a 2-Point Improvement in the Ordinal Scale up to Day 7
Time frame: Baseline up to Day 7
Percentage of Participants With at Least a 1-Point Improvement in the Ordinal Scale
Time frame: Baseline up to Day 7 and 14
Time to Clinical Improvement of 2-points Using Ordinal Scale (TTCI-2)
Time frame: Baseline up to Day 28
Overall Death Rate
Time frame: Baseline up to Day 28
Rate of Mechanical Ventilation (RMV)
Time frame: Baseline up to Day 28
Rate of Intensive Care Unit (ICU) Admission
Time frame: Baseline up to Day 28
Length of Hospitalization
Time frame: Baseline up to Day 67
Change From Baseline in C-reactive Protein (CRP) Levels
Time frame: Baseline, Day 3, 5, 8, 12, 15, 19, 22 and 26
Change From Baseline in Ferritin Levels
Time frame: Baseline, Day 3, 5, 8, 12, 15, 19, 22 and 26
Change From Baseline in Lactate Dehydrogenase (LDH) Levels
Time frame: Baseline, Day 3, 5, 8, 12, 15, 19, 22 and 26
Changes From Baseline in Blood Plasma Cytokines Levels-Interleukin-6 (IL-6)
Time frame: Baseline, Day 3, 5, 8, 12, 15, 22 and 26
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: From start of study drug administration up to Day 58
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Selinexor in people with Coronavirus Infection, run by Karyopharm Therapeutics Inc at 33 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 9 inclusion and 16 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 20 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 33 sites in United States, United Kingdom, France, Israel, Spain 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With At-least a 2-Point Improvement in Ordinal Scale (time frame: Baseline up to Day 14). 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 20 Jan 2023.