SepsisPhase 2GRANTISSNCT03924518
Adjunctive Granisetron Therapy in Patients With Sepsis or Septic Shock
A Phase 2 study testing Granisetron Hydrochloride in people with Sepsis, run by Zhujiang Hospital at 1 site in China.
Trial summary
In this prospective, single-center,randomized,controlled,single-blind clinical trial,Patients will be randomly assigned to receive granisetron or placebo for 4 days or until leaving the ICU(death or transfer from ICU to general ward or discharge). The primary outcome is all-cause death rate at 28 days. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Granisetron Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2019to 28 Dec 2020
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Age<18 years, or age>80 years.
- Pregnancy or lactating
- A solid-organ or bone marrow transplant patients.
- Patients with myocardial infarction within the past 3 months.
- Advanced pulmonary fibrosis .
- Patients with cardiopulmonary resuscitation before enrollment.
Show all 16Show fewer
- HIV-positive patients.
- granulocyte-deficient patients.
- blood/lymphatic system tumors are not remission.
- patients with limited care (lack of commitment to full，aggressive life support).
- patients with long-term use of immunosuppressive drugs or with immunodeficiency.
- patients with advanced tumors.
- patients combined with non-infectious factors leading to the death(uncontrollable major bleeding, brain hernia, etc.).
- surgically unresolved infection sources(such as some intraperitoneal infection etc.)
- patients allergic to granisetron.
- patients with intestinal obstruction.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University
Guangzhou, Guangdong, 510282
About this study
Official title: Adjunctive Granisetron Therapy in Patients With Sepsis or Septic Shock：A Single-center, Randomized, Controlled, Single-blind Clinical Trial
In this prospective, single-center,randomized,controlled,single-blind clinical trial,Patients will be randomly assigned to receive granisetron or placebo for 4 days or until leaving the ICU(death or transfer from ICU to general ward or discharge). The primary outcome is all-cause death rate at 28 days.
Read the detailed description
Investigational drug：Granisetron hydrochloride for injection
Study title：Adjunctive Granisetron Therapy in Patients with Sepsis or Septic Shock:A Single-center,Randomized,Controlled,Single-blind Clinical trial.
Principal Investigator：Professor Ping Chang ,Professor Zhanguo Liu, professor Peng Chen,Department of Critical Care Unit, Zhujiang Hospital, Southern Medical University
Study subjects：Adult septic/septic shock patients with procalcitonin(PCT≥2ng/ml when entering the ICU.
Study phase： Investigator Initiated Trial(IIT)
Study objectives：The objective of the study is to determine whether granisetron, compared to placebo, improve the prognosis of sepsis or septic shock,including the reduction in mortality, the protection of organ function and reduction of inflammatory response,and to determine the safety of granisetron in patients with sepsis.
Study design：A Single-center,Randomized,Controlled,Single-blind Clinical trial.
Medication method： Granisetron treatment group： Follow the guidelines for sepsis in 2016 and recommend routine treatment + 3mg granisetron in 22 ml normal saline every 8 h for 4 days or until leaving the ICU(death or transfer from ICU to general ward or discharge), whichever come first.
Placebo control group：Follow the guidelines for sepsis in 2016 and recommend routine treatment + 25ml normal saline every 8 h for 4 days or until leaving the ICU(death or transfer from ICU to general ward or discharge), whichever come first.
Course：4days
Sample size：154.
Sites：1
Primary endpoint：all-cause death at 28 days
Secondary endpoints:
- The state of liver function: the serum level of transaminase(AST、ALT)、total bilirubin、direct bilirubin at 1,2,3,4,5 days after randomization
- The state of lung function:oxygenation index(PaO2/FiO2) at 1,2,3,4,5 days after randomization (the patients treated with extracorporeal membrane oxygenation will not collect this indicator).
- The state of kidney function:serum level of Creatinine (Cr)、blood urea nitrogen(BUN)、Cystatin(Cys) at 1,2,3,4,5 days after randomization
- The state of inflammatory response:the serum level of interleukin-6(IL-6) 、C-reactive protein 、Superoxide dismutase(SOD) and erythrocyte sedimentation rate(ESR) at 1,3,5 days after randomization.
- The state of circulation system: the serum level of lactic acid at 1,2,3,4,5 days after randomization
- The state of immune function:the serum level of white blood cell(WBC)、lymphocyte at 1, 3, 5 days after randomization,the serum level of cluster of differentiation 4 Tcell(CD4+ Tcell) and cluster of differentiation 8 Tcell(CD8+ Tcell) at 1,5days after randomization.
- The level of plasma 5-hydroxytryptamine(5-HT) at 1,5 days after randomization.
- Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score at 1, 3, 5 after randomization
- Incidence and duration of supportive care for organ dysfunction including vasoactive agents, mechanical ventilation, continuous renal replacement therapy(CRRT)、daily condition of fuid balance
- The length of stay in ICU
Safety endpoints：
- adverse events
- Serious adverse events
- Conditions
- Sepsis
- Being tested
- Granisetron Hydrochloride, Placebo（Normal saline）
- Keywords
- sepsis, septic shock, granisetron
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granisetron HydrochlorideDrug
Also called Selective 5-hydroxytryptamine 3 receptor inhibitor
Granisetron will be diluted with 0.9% saline to ensure that the therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs.
Placebo（Normal saline）Drug
Also called 0.9% saline
therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs.
| Study group | Role | What they receive |
|---|---|---|
| granisetron group | Experimental | 3ml granisetron（3mg） will be diluted in 22 mL of 0.9% normal saline,and the granisetron diluted will be intravenously injected for at 10 minutes， every 8 hours for 4 days or until leaving the ICU(death or transfer from ICU to general ward or discharge), whichever come first. Receives: Drug: Granisetron Hydrochloride |
| placebo group | Placebo comparator | Normal saline 25ml every 8h for 4 days or until leaving the ICU(death or transfer from ICU to general ward or discharge), whichever come first. Receives: Drug: Placebo（Normal saline） |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality rate
All-cause mortality rate from the enrollment to the 28th days
Measured: 28 days
Secondary outcomes (26)
liver function(1)
the serum level of Alanine transaminase(ALT)
Measured: Day at 1,2,3,4,5 after randomization
liver function(2)
the serum level of Aspartate transaminase (AST)
Measured: Day at 1,2,3,4,5 after randomization
liver function(3)
the serum level of total bilirubin
Measured: Day at 1,2,3,4,5 after randomization
liver function(4)
the serum level of direct bilirubin
Measured: Day at 1,2,3,4,5 after randomization
lung function
oxygenation index(PaO2/FiO2)，the patients treated with extracorporeal membrane oxygenation will not collect this indicator
Measured: Day at 1,2,3,4,5 after randomization
kidney function(1)
serum level of Creatinine (Cr)
Measured: Day at 1,2,3,4,5 after randomization
kidney function(2)
serum level of blood urea nitrogen(BUN)
Measured: Day at 1,2,3,4,5 after randomization
kidney function(3)
serum level of Cystatin(Cys)
Measured: Day at 1,2,3,4,5 after randomization
inflammatory response(1)
the serum level of interleukin-6(IL-6)
Measured: Day at 1,3,5 after randomization.
inflammatory response(2）
the serum level of C-reactive protein(CRP)
Measured: Day at 1,3,5 after randomization.
inflammatory response(3）
the serum level of superoxide dismutase(SOD)
Measured: Day at 1,3,5 after randomization.
inflammatory response(4）
the serum level of erythrocyte sedimentation rate(ESR)
Measured: Day at 1,3,5 after randomization.
The level of lactic acid
the serum level of lactic acid
Measured: Day at 1,2,3,4,5 after randomization
immune function(1)
the serum level of white blood cell(WBC)
Measured: Day at 1, 3, 5 after randomization for test the the serum level of white blood cell(WBC).
immune function(2)
the serum level of lymphocyte
Measured: Day at 1, 3, 5 after randomization for test the the serum level of lymphocyte.
immune function(3)
the serum level of CD4+ Tcell
Measured: Day at 1,5 after randomization for test the the serum level of CD4+ Tcell.
immune function(4)
the serum level of CD8+Tcell
Measured: Day at 1, 5 after randomization for test the the serum level of CD8+Tcell.
The level of 5-hydroxytryptamine (5-HT)
The level of plasma 5-HT
Measured: Day at 1,5 after randomization.
Sequential Organ Failure Assessment (SOFA) score
Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score.SOFA score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems.The highest score for each of the six items is 4 points, and the lowest score is 0 points.Finally, the scores of the six items are summed to get the value of the sofa score.The range of the sofa score is 0-24.Higher values represent a worse outcome.
Measured: Day at 1, 3, 5 after randomization
The proportion of patients receiving mechanical ventilation
The proportion of patients receiving mechanical ventilation within 28 days after randomization
Measured: 28 days
The proportion of patients receiving vasoactive drugs
The proportion of patients receiving vasoactive drugs within 28 days after randomization
Measured: 28 days
The proportion of patients receiving renal replacement therapy(CRRT)
The proportion of patients receiving CRRT within 28 days after randomization
Measured: 28 days
The duration of mechanical ventilation
The the duration of mechanical ventilation therapy in hours( This outcome measure is intended only for patients receiving mechanical ventilation)
Measured: 28 days
The duration of vasoactive drugs
The the duration of vasoactive drugs therapy in hours( This outcome measure is intended only for patients receiving vasoactive drugs)
Measured: 28 days
The duration of CRRT
The the duration of CRRT therapy in hours( This outcome measure is intended only for patients receiving CRRT)
Measured: 28 days
ICU length of stay
ICU length of stay
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start25 Apr 2019
- Primary completion28 Nov 2020
- Study completion28 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe 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
- Model description
- The participants in treatment group receive intravenous granisetron. The participants in control group receive normal saline.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ping Chang, M.D.PhD, Principal investigator, Department of Critical Care Medicine of Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924518
- Sponsor's protocol ID
- 2018-ZZJHZX-009
- Acronym
- GRANTISS
- Status last verified
- Jan 2021
- First submitted
- 15 Apr 2019
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: since some data may involve patients privacy ，we have no plans to share data so far，and some data may be shared later depending on the patient's wishes.
Publications
Gong S, Yan Z, Liu Z, Niu M, Fang H, Li N, Huang C, Li L, Chen G, Luo H, Chen X, Zhou H, Hu J, Yang W, Huang Q, Schnabl B, Chang P, Billiar TR, Jiang Y, Chen P. Intestinal Microbiota Mediates the Susceptibility to Polymicrobial Sepsis-Induced Liver Injury by Granisetron Generation in Mice. Hepatology. 2019 Apr;69(4):1751-1767. doi: 10.1002/hep.30361. Epub 2019 Mar 5.
PubMed 30506577Guan J, Guo Y, Chang P, Gan J, Zhou J, Wang H, Cen Z, Tang Y, Liu Z, Chen P. Adjunctive granisetron therapy in patients with sepsis or septic shock (GRANTISS): Study protocol for a randomized controlled trial. Medicine (Baltimore). 2019 Sep;98(39):e17354. doi: 10.1097/MD.0000000000017354.
PubMed 31574878
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Granisetron Therapy in Patients With Sepsis or Septic Shock：A Single-center, Randomized, Controlled, Single-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT03924518
- Acronym / sponsor ID
- GRANTISS / 2018-ZZJHZX-009
- Conditions
- Sepsis
- Keywords
- sepsis, septic shock, granisetron
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 28 Nov 2020 (actual)
- Study completion
- 28 Dec 2020 (actual)
- First posted
- 23 Apr 2019 (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.
In this prospective, single-center,randomized,controlled,single-blind clinical trial,Patients will be randomly assigned to receive granisetron or placebo for 4 days or until leaving the ICU(death or transfer from ICU to general ward or discharge). The primary outcome is all-cause death rate at 28 days.
Detailed description
Investigational drug：Granisetron hydrochloride for injection
Study title：Adjunctive Granisetron Therapy in Patients with Sepsis or Septic Shock:A Single-center,Randomized,Controlled,Single-blind Clinical trial.
Principal Investigator：Professor Ping Chang ,Professor Zhanguo Liu, professor Peng Chen,Department of Critical Care Unit, Zhujiang Hospital, Southern Medical University
Study subjects：Adult septic/septic shock patients with procalcitonin(PCT≥2ng/ml when entering the ICU.
Study phase： Investigator Initiated Trial(IIT)
Study objectives：The objective of the study is to determine whether granisetron, compared to placebo, improve the prognosis of sepsis or septic shock,including the reduction in mortality, the protection of organ function and reduction of inflammatory response,and to determine the safety of granisetron in patients with sepsis.
Study design：A Single-center,Randomized,Controlled,Single-blind Clinical trial.
Medication method： Granisetron treatment group： Follow the guidelines for sepsis in 2016 and recommend routine treatment + 3mg granisetron in 22 ml normal saline every 8 h for 4 days or until leaving the ICU(death or transfer from ICU to general ward or discharge), whichever come first.
Placebo control group：Follow the guidelines for sepsis in 2016 and recommend routine treatment + 25ml normal saline every 8 h for 4 days or until leaving the ICU(death or transfer from ICU to general ward or discharge), whichever come first.
Course：4days
Sample size：154.
Sites：1
Primary endpoint：all-cause death at 28 days
Secondary endpoints:
- The state of liver function: the serum level of transaminase(AST、ALT)、total bilirubin、direct bilirubin at 1,2,3,4,5 days after randomization
- The state of lung function:oxygenation index(PaO2/FiO2) at 1,2,3,4,5 days after randomization (the patients treated with extracorporeal membrane oxygenation will not collect this indicator).
- The state of kidney function:serum level of Creatinine (Cr)、blood urea nitrogen(BUN)、Cystatin(Cys) at 1,2,3,4,5 days after randomization
- The state of inflammatory response:the serum level of interleukin-6(IL-6) 、C-reactive protein 、Superoxide dismutase(SOD) and erythrocyte sedimentation rate(ESR) at 1,3,5 days after randomization.
- The state of circulation system: the serum level of lactic acid at 1,2,3,4,5 days after randomization
- The state of immune function:the serum level of white blood cell(WBC)、lymphocyte at 1, 3, 5 days after randomization,the serum level of cluster of differentiation 4 Tcell(CD4+ Tcell) and cluster of differentiation 8 Tcell(CD8+ Tcell) at 1,5days after randomization.
- The level of plasma 5-hydroxytryptamine(5-HT) at 1,5 days after randomization.
- Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score at 1, 3, 5 after randomization
- Incidence and duration of supportive care for organ dysfunction including vasoactive agents, mechanical ventilation, continuous renal replacement therapy(CRRT)、daily condition of fuid balance
- The length of stay in ICU
Safety endpoints：
- adverse events
- Serious adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The participants in treatment group receive intravenous granisetron. The participants in control group receive normal saline.
| Arm | Type | Receives |
|---|---|---|
| granisetron group | Experimental | Drug: Granisetron Hydrochloride3ml granisetron（3mg） will be diluted in 22 mL of 0.9% normal saline,and the granisetron diluted will be intravenously injected for at 10 minutes， every 8 hours for 4 days or until leaving the ICU(death or transfer from ICU to general ward or discharge), whichever come first. |
| placebo group | Placebo comparator | Drug: Placebo（Normal saline）Normal saline 25ml every 8h for 4 days or until leaving the ICU(death or transfer from ICU to general ward or discharge), whichever come first. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- Age<18 years, or age>80 years.
- Pregnancy or lactating
- A solid-organ or bone marrow transplant patients.
- Patients with myocardial infarction within the past 3 months.
- Advanced pulmonary fibrosis .
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 |
|---|---|---|
| Granisetron HydrochlorideAlso: Selective 5-hydroxytryptamine 3 receptor inhibitorGranisetron will be diluted with 0.9% saline to ensure that the therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs. | Drug | granisetron group |
| Placebo（Normal saline）Also: 0.9% salinetherapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs. | Drug | placebo group |
Primary outcome
all-cause mortality rate
Time frame: 28 days
All-cause mortality rate from the enrollment to the 28th days
26 secondary outcomes
liver function(1)
Time frame: Day at 1,2,3,4,5 after randomization
liver function(2)
Time frame: Day at 1,2,3,4,5 after randomization
liver function(3)
Time frame: Day at 1,2,3,4,5 after randomization
liver function(4)
Time frame: Day at 1,2,3,4,5 after randomization
lung function
Time frame: Day at 1,2,3,4,5 after randomization
kidney function(1)
Time frame: Day at 1,2,3,4,5 after randomization
kidney function(2)
Time frame: Day at 1,2,3,4,5 after randomization
kidney function(3)
Time frame: Day at 1,2,3,4,5 after randomization
inflammatory response(1)
Time frame: Day at 1,3,5 after randomization.
inflammatory response(2）
Time frame: Day at 1,3,5 after randomization.
inflammatory response(3）
Time frame: Day at 1,3,5 after randomization.
inflammatory response(4）
Time frame: Day at 1,3,5 after randomization.
The level of lactic acid
Time frame: Day at 1,2,3,4,5 after randomization
immune function(1)
Time frame: Day at 1, 3, 5 after randomization for test the the serum level of white blood cell(WBC).
immune function(2)
Time frame: Day at 1, 3, 5 after randomization for test the the serum level of lymphocyte.
immune function(3)
Time frame: Day at 1,5 after randomization for test the the serum level of CD4+ Tcell.
immune function(4)
Time frame: Day at 1, 5 after randomization for test the the serum level of CD8+Tcell.
The level of 5-hydroxytryptamine (5-HT)
Time frame: Day at 1,5 after randomization.
Sequential Organ Failure Assessment (SOFA) score
Time frame: Day at 1, 3, 5 after randomization
The proportion of patients receiving mechanical ventilation
Time frame: 28 days
The proportion of patients receiving vasoactive drugs
Time frame: 28 days
The proportion of patients receiving renal replacement therapy(CRRT)
Time frame: 28 days
The duration of mechanical ventilation
Time frame: 28 days
The duration of vasoactive drugs
Time frame: 28 days
The duration of CRRT
Time frame: 28 days
ICU length of stay
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Background: PubMed 30506577Gong S, Yan Z, Liu Z, Niu M, Fang H, Li N, Huang C, Li L, Chen G, Luo H, Chen X, Zhou H, Hu J, Yang W, Huang Q, Schnabl B, Chang P, Billiar TR, Jiang Y, Chen P. Intestinal Microbiota Mediates the Susceptibility to Polymicrobial Sepsis-Induced Liver Injury by Granisetron Generation in Mice. Hepatology. 2019 Apr;69(4):1751-1767. doi: 10.1002/hep.30361. Epub 2019 Mar 5.
- Derived from this study: PubMed 31574878Guan J, Guo Y, Chang P, Gan J, Zhou J, Wang H, Cen Z, Tang Y, Liu Z, Chen P. Adjunctive granisetron therapy in patients with sepsis or septic shock (GRANTISS): Study protocol for a randomized controlled trial. Medicine (Baltimore). 2019 Sep;98(39):e17354. doi: 10.1097/MD.0000000000017354.
- Our previous researchLink provided by the sponsor.
- Individual participant dataSharing planned: No. since some data may involve patients privacy ，we have no plans to share data so far，and some data may be shared later depending on the patient's wishes.
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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.
ping Chang, M.D.PhD principal investigator
Department of Critical Care Medicine of Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Granisetron Hydrochloride in people with Sepsis, run by Zhujiang Hospital at 1 site in China.
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 0 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 7 Jul 2022. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
all-cause mortality rate (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03924518, which also lists 2 linked publications.
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 Jul 2022.