CoronavirusPhase 2CX4945NCT04668209
Silmitasertib (CX-4945) in Patients With Severe Coronavirus Disease 2019 (COVID-19)
A Phase 2 study testing Silmitasertib in people with Coronavirus, run by University of Arizona at 2 sites in United States.
Trial summary
This multi-center, open-label, 2 arm parallel-group, randomized, interventional prospective exploratory study in 40 patients aimed to evaluate safety and explore putative clinical benefits of Silmitasertib 1000 mg BID dose in patients with severe illness caused be SARS-COV-2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus
- What is being tested?
- Silmitasertib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jan 2021to 19 Oct 2022
- 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
- Male or non-pregnant female adult ≥ 18 years of age
- Diagnosed/confirmed with COVID-19 by standard RT-PCR assay or equivalent testing within 7 days prior to randomization (Day1).
- Hospitalized patient with severe illness caused by SARS-CoV-2 (Note: Prior or current use of remdesivir or dexamethasone (SOC) are allowed under the investigator's discretion. Concomitant treatment with other investigational antiviral drugs or immunomodulators are not permitted from Day1 through Day 28)
- Symptoms of severe systemic illness/infection with COVID-19:
- At least 1 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 infection including dyspnea at rest or respiratory distress AND Clinical signs indicative of severe systemic illness/infection with COVID-19 At least 1 of the following: RR ≥ 30, HR ≥ 125, SaO2 <93% on room air or requires > 2L oxygen by nasal cannula in order to maintain SaO2 ≥93%
- Patient (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
Show all 17Show fewer
- Adequate hematopoietic capacity, as defined by the following:
- Hemoglobin ≥ 9.0 g/dL and not transfusion dependent
- Platelets ≥ 100,000/mm3
- Absolute neutrophil count ≥ 1500 cells/mm3
- Adequate hepatic function, as defined by the following:
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 x ULN
- Albumin ≥ 3.0 g/dL
- Adequate renal function, as defined by the following:
- Renal: calculated creatinine clearance >45 mL/min for patients with abnormal, increased creatinine levels (Cockcroft-Gault formula).
- Ability to take oral medication and be willing to adhere to drug administration and premedication requirements (see Section 6.3) throughout study duration.
Who cannot join
- Patient showing signs of respiratory failure necessitating mechanical ventilation
- Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately.
- Active or uncontrolled infections other than COVID-19 or with serious illnesses or medical conditions which would not permit the patient to receive study treatment
- Active or planned concomitant treatment with other investigational antivirals or immunomodulators
- Chronic diarrhea (excess of 2-3 stools/day above normal frequency)
- Current use or anticipated need for drugs that are known strong inhibitors or inducers of major CYP enzymes.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
Banner University Medical Center Tucson
Tucson, Arizona, 85724
About this study
Official title: Phase II, Randomized, Investigator Initiated Trial to Evaluate Safety and to Explore Clinical Benefit of Silmitasertib (CX-4945) in Patients With Severe Coronavirus Disease 2019 (COVID-19)
This multi-center, open-label, 2 arm parallel-group, randomized, interventional prospective exploratory study in 40 patients aimed to evaluate safety and explore putative clinical benefits of Silmitasertib 1000 mg BID dose in patients with severe illness caused be SARS-COV-2. This will be a two-arm trial comparing the SOC/best supportive care alone to the SOC/best supportive care with addition of Silmitasertib (allocation ratio 1:1).
Read the detailed description
This is a phase II multi-center, randomized, open-label, 2 arm parallel-group controlled interventional prospective study of CX-4945 in patients with severe COVID-19. Up to approximately 40 patients will be enrolled into this study. A screening evaluation will occur within 7 days prior to Day 1. All qualified patients will be randomized at Day 1 in a ratio of 1:1 to one of the following two treatment arms:
Arm A: SOC/ best supportive care in combination with CX-4945 1000 mg BID PO or Arm B: SOC/ best supportive care alone The standard of care (SOC) is not pre-specified, may vary among patients, and may include agents with anti-viral activity, such as remdesivir, among others. Investigator discretion is to be applied for any established SOC. Active concomitant treatment with other investigational antivirals or immunomodulators are not permitted Best supportive care is defined as intensive care therapy according to current guidelines, evidence, and best practice, including but not limited to lung protective ventilation, thrombosis prophylaxis, renal replacement therapy when indicated, and access to advanced therapies including extracorporeal membrane oxygenation.
The total duration of the treatment will be 14 days. Patients will be followed up at 28, 45 and 60 days from the start of the treatment. The total duration for each patient in the study (including the screening) will be up to 67 days.
- Conditions
- Coronavirus
- Being tested
- Silmitasertib
- Keywords
- SARS-CoV-2, COVID-19
- 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.
SilmitasertibDrug
Also called CX-4945
Standard of care / best supportive care in combination with CX-4945 1000 mg administered orally, two times a day.
| Study group | Role | What they receive |
|---|---|---|
| Silmitasertib | Active comparator | Standard of care / supportive care in combination with Silmitasertib (CX-4945) Receives: Drug: Silmitasertib |
| Standard of Care | No intervention | Standard of care / supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]
Adverse Events experienced by the patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
Measured: Through Day 60
Secondary outcomes (22)
To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.
Number of days from randomization to discharge, or to alleviation of cough (defined as mild or absent in a patient reported scale of 0=absent, 1=mild, 2=moderate, and 3=severe). Improvement must be sustained for at least 48 hours.
Measured: Through Day 28
To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.
Number of days from randomization to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), normalization of respiratory rate (< 24 bpm while breathing room air), resolution of hypoxia (defined as SpO2 ≥ 93% in room air or P/F ≥ 300 mmHg). All these improvements must be sustained for at least 48 hours.
Measured: Through hospital discharge, an average of 28 days
To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.
Number of days from randomization to the first day on which the subject satisfies one of the following three categories from the ordinal NIAID 8- point Clinical Progression Outcomes scale collected daily from randomization through Day 28:
Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities.
Measured: Through Day 28
To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.
Difference in percentage of subjects with clinical recovery compared at Day 14 and Day 28.
Measured: Assessed on Day 14 and Day 28
To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.
Percentage of Participants at Each Clinical Status at Day 14 and Day 28 assessed by using the ordinal NIAID 8- point Clinical Progression Outcomes scale (Scale ranges from 1 (Death) to 8 (Not hospitalized, no limitations on activities)
Measured: Through Day 28
To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm.
Difference in proportions of patients with conversion of positive RT-PCR to negative RT-PCR as assessed at Day 1, Day 8, Day 14 and Day 28.
Measured: Assessed at Day 1, Day 8, Day 14 and Day 28
To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm.
Changes in chest imaging from Screening to Day 5 or 14
Measured: Through Day 14
Number of Days Hospitalized
Days of hospitalization from randomization through Day 28
Measured: Through Day 28
To Evaluate Changes in IL-6 Level
IL-6 level
Measured: Assessed on Days 1, 4, 8, 11, and 14
To Evaluate Changes in CRP
CRP level
Measured: Assessed on Days 1, 4, 8, 11, and 14
To Evaluate Changes in LDH
LDH level
Measured: Assessed on Days 1, 4, 8, 11, and 14
To Evaluate Changes in CPK
CPK level
Measured: Assessed on Days 1, 4, 8, 11, and 14
To Evaluate Changes in Ferritin
Ferritin level
Measured: Assessed on Days 1, 4, 8, 11, and 14
To Evaluate Changes in D-dimer
D-dimer level
Measured: Assessed on Days 1, 4, 8, 11, and 14
Number of Days of Supplemental Oxygen Use
Days of supplemental oxygen (if applicable) from randomization through day 28
Measured: Through Day 28
All-cause Mortality Status
The number of deaths occurred in each treatment group from randomization through Day 60
Measured: Through Day 60
Number of Days of On-invasive Ventilation/High Flow Oxygen
Days of non-invasive ventilation/high flow oxygen (if applicable) from randomization through day 28
Measured: Through Day 28
Number of Days of Invasive Mechanical Ventilation/ECMO
Days of invasive mechanical ventilation/ECMO (if applicable) from randomization through Day 28.
Measured: Through Day 28
Number of Patients Returned to Room Air
Number of patients returned to room air after randomization through Day 14 or Day 28.
Measured: Through Day 28
Change in Pulse Oxygen Saturation
Change in pulse oxygen saturation (SpO2) from randomization to Day 4, 8, 11, 14 and 28
Measured: Days 4, 8, 11, 14, and 28
Number of Thrombosis Events
Number of documented venous thromboembolism (VTE), arterial thrombosis (stroke, myocardial infarction, other) and microthrombosis events from randomization through Day 28
Measured: Through Day 28
Changes in EQ-D5-5L
The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). Higher values indicate worse outcomes, while lower indicate better outcomes. The subscales are combined to compute a total score and averaged to produce the mean and SD.
Changes in EQ-D5-5L (used as an indicator of symptom improvement) from randomization to Day 8, 14 and 28
Measured: Days randomization, 8, 14 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start21 Jan 2021
- Primary completion30 Jun 2022
- Study completion19 Oct 2022
Why it stopped: After 15 months of active enrollment and a lack of qualifying hospitalized COVID-19 patients, the Sponsor-Investigator, Marilyn Csete Glassberg, MD, decided to terminate recruitment before meeting the stated enrollment objectives.
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 CoronavirusStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Senhwa Biosciences, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668209
- Sponsor's protocol ID
- CX4945-AV02-IIT
- Acronym
- CX4945
- Status last verified
- Nov 2022
- First submitted
- 2 Dec 2020
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Study results will be published on clinicaltrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Randomized, Investigator Initiated Trial to Evaluate Safety and to Explore Clinical Benefit of Silmitasertib (CX-4945) in Patients With Severe Coronavirus Disease 2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT04668209
- Acronym / sponsor ID
- CX4945 / CX4945-AV02-IIT
- Conditions
- Coronavirus
- Keywords
- SARS-CoV-2, COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After 15 months of active enrollment and a lack of qualifying hospitalized COVID-19 patients, the Sponsor-Investigator, Marilyn Csete Glassberg, MD, decided to terminate recruitment before meeting the stated enrollment objectives.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Senhwa Biosciences, Inc.
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 16 Dec 2020 (actual)
- Results
- Posted 14 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-center, open-label, 2 arm parallel-group, randomized, interventional prospective exploratory study in 40 patients aimed to evaluate safety and explore putative clinical benefits of Silmitasertib 1000 mg BID dose in patients with severe illness caused be SARS-COV-2. This will be a two-arm trial comparing the SOC/best supportive care alone to the SOC/best supportive care with addition of Silmitasertib (allocation ratio 1:1).
Detailed description
This is a phase II multi-center, randomized, open-label, 2 arm parallel-group controlled interventional prospective study of CX-4945 in patients with severe COVID-19. Up to approximately 40 patients will be enrolled into this study. A screening evaluation will occur within 7 days prior to Day 1. All qualified patients will be randomized at Day 1 in a ratio of 1:1 to one of the following two treatment arms:
Arm A: SOC/ best supportive care in combination with CX-4945 1000 mg BID PO or Arm B: SOC/ best supportive care alone The standard of care (SOC) is not pre-specified, may vary among patients, and may include agents with anti-viral activity, such as remdesivir, among others. Investigator discretion is to be applied for any established SOC. Active concomitant treatment with other investigational antivirals or immunomodulators are not permitted Best supportive care is defined as intensive care therapy according to current guidelines, evidence, and best practice, including but not limited to lung protective ventilation, thrombosis prophylaxis, renal replacement therapy when indicated, and access to advanced therapies including extracorporeal membrane oxygenation.
The total duration of the treatment will be 14 days. Patients will be followed up at 28, 45 and 60 days from the start of the treatment. The total duration for each patient in the study (including the screening) will be up to 67 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silmitasertib | Active comparator | Drug: SilmitasertibStandard of care / supportive care in combination with Silmitasertib (CX-4945) |
| Standard of Care | No intervention | –Standard of care / supportive care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male or non-pregnant female adult ≥ 18 years of age
- Diagnosed/confirmed with COVID-19 by standard RT-PCR assay or equivalent testing within 7 days prior to randomization (Day1).
- Hospitalized patient with severe illness caused by SARS-CoV-2 (Note: Prior or current use of remdesivir or dexamethasone (SOC) are allowed under the investigator's discretion. Concomitant treatment with other investigational antiviral drugs or immunomodulators are not permitted from Day1 through Day 28)
- At least 1 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 infection including dyspnea at rest or respiratory distress AND Clinical signs indicative of severe systemic illness/infection with COVID-19 At least 1 of the following: RR ≥ 30, HR ≥ 125, SaO2 <93% on room air or requires > 2L oxygen by nasal cannula in order to maintain SaO2 ≥93%
- Patient (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
Key exclusion criteria (6 listed)
- Patient showing signs of respiratory failure necessitating mechanical ventilation
- Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately.
- Active or uncontrolled infections other than COVID-19 or with serious illnesses or medical conditions which would not permit the patient to receive study treatment
- Active or planned concomitant treatment with other investigational antivirals or immunomodulators
- Chronic diarrhea (excess of 2-3 stools/day above normal frequency)
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 |
|---|---|---|
| SilmitasertibAlso: CX-4945Standard of care / best supportive care in combination with CX-4945 1000 mg administered orally, two times a day. | Drug | Silmitasertib |
Primary outcome
Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]
Time frame: Through Day 60
Adverse Events experienced by the patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
22 secondary outcomes
To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.
Time frame: Through Day 28
To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.
Time frame: Through hospital discharge, an average of 28 days
To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.
Time frame: Through Day 28
To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.
Time frame: Assessed on Day 14 and Day 28
To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.
Time frame: Through Day 28
To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm.
Time frame: Assessed at Day 1, Day 8, Day 14 and Day 28
To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm.
Time frame: Through Day 14
Number of Days Hospitalized
Time frame: Through Day 28
To Evaluate Changes in IL-6 Level
Time frame: Assessed on Days 1, 4, 8, 11, and 14
To Evaluate Changes in CRP
Time frame: Assessed on Days 1, 4, 8, 11, and 14
To Evaluate Changes in LDH
Time frame: Assessed on Days 1, 4, 8, 11, and 14
To Evaluate Changes in CPK
Time frame: Assessed on Days 1, 4, 8, 11, and 14
To Evaluate Changes in Ferritin
Time frame: Assessed on Days 1, 4, 8, 11, and 14
To Evaluate Changes in D-dimer
Time frame: Assessed on Days 1, 4, 8, 11, and 14
Number of Days of Supplemental Oxygen Use
Time frame: Through Day 28
All-cause Mortality Status
Time frame: Through Day 60
Number of Days of On-invasive Ventilation/High Flow Oxygen
Time frame: Through Day 28
Number of Days of Invasive Mechanical Ventilation/ECMO
Time frame: Through Day 28
Number of Patients Returned to Room Air
Time frame: Through Day 28
Change in Pulse Oxygen Saturation
Time frame: Days 4, 8, 11, 14, and 28
Number of Thrombosis Events
Time frame: Through Day 28
Changes in EQ-D5-5L
Time frame: Days randomization, 8, 14 and 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Study results will be published on clinicaltrials.gov.
Related trials for Coronavirus
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Silmitasertib in people with Coronavirus, run by University of Arizona at 2 sites in United States.
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 17 inclusion and 6 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: stopped early, as of the sponsor's last update on 7 Nov 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 United States. 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 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 14 Aug 2023). 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?
Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] (time frame: Through Day 60). 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 7 Nov 2023.