Covid19Phase 3ARBs CORONA IINCT04606563
Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan and Other ARBs on Outcomes of Coronavirus Infection?
A Phase 3 study testing Losartan, Valsartan and Azilsartan in people with Covid19 and SARS-CoV Infection, run by University of British Columbia at 13 sites in 2 countries.
Trial summary
SARS-CoV-2 is a member of a class of viruses: angiotensin converting enzyme 2 (ACE2)-binding viruses that study calls "ABVs". The World Health Organization (WHO) and others are performing randomized controlled trials (RCTs) of vaccines and novel antivirals to address SARS-CoV-2 directly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, SARS-CoV Infection
- What is being tested?
- Losartan, Valsartan and Azilsartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 341 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 9 Oct 2020to 22 Apr 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized
- Must be first admission of COVID-19, not re-admission
- Primary reason for hospitalization or prolonged hospitalization is because of acute COVID-19 diagnosis
- Adults 18 years of age or greater
- Laboratory-proven COVID-19 within 14 days prior to hospital admission
Who cannot join
- Hypotension (SAP < 100 mmHg or DAP < 50 mmHg or MAP < 65 mmHg)
- Hyperkalemia (> 5.5 mmol/l)
- Acute kidney injury (urine output < 0.5 ml/kg/hr and new creatinine > 200 mmol/l, or increase > 100 mmol/l, or GFR < 30 ml/min)
- Use of aliskiren in patients with diabetes mellitus (type 1 or type 2) or moderate-severe renal impairment (GFR less than 60mL/min)
- Use of ARB/ACEi within 7 days of presentation
- Pregnant or breastfeeding
Show all 9Show fewer
- Have a known allergy to ARBs or any component of the drug product
- Have written legal document to withhold life-sustaining (patients not wishing to receive Cardiopulmonary Resuscitation (CPR) can participate if other medical treatments will be given)
- Have signed a Do No Resuscitate (DNR) Form
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Canada12 sites
University of Calgary - Foothills
Calgary, Alberta
CHU de Québec - Université Laval
Laval, Quebec
McGill University Health Center
Montreal, Quebec
Royal Jubilee Hospital
Nanaimo, British Columbia
The Ottawa Hospital
Ottawa, Ontario
Niagara Health
Saint Catharines, Ontario
Université de Sherbrooke
Sherbrooke, Quebec
Surrey Memorial Hospital
Surrey, British Columbia, V3V 1Z2
St Michael's Hospital
Toronto, Ontario
Sunnybrook Hospital
Toronto, Ontario
St Paul's Hospital
Vancouver, British Columbia, V6Z1Y6
Vancouver General Hospital
Vancouver, British Columbia
About this study
SARS-CoV-2 is a member of a class of viruses: angiotensin converting enzyme 2 (ACE2)-binding viruses that study calls "ABVs". The World Health Organization (WHO) and others are performing randomized controlled trials (RCTs) of vaccines and novel antivirals to address SARS-CoV-2 directly. However, the critical illness complications of COVID-19 are caused in part by SARS-CoV-2's binding and inhibiting ACE2 and the consequent host response.
ACE 2 is the receptor for H1N1, H5N1, and SARS-CoV-2. After binding ACE2, SARS-CoV-2 is endocytosed, and surface ACE2 is down-regulated, increasing angiotensin II (ATII a potent vasoconstrictor) in COVID-19. The original ARBs limits lung injury in murine influenza H7N9 and decreases viral titre and RNA.
Study has a unique opportunity to complement vaccine and anti-viral RCTs with an RCT modulating the host response using an angiotensin II type 1 receptor blocker (ARBs) to decrease the mortality of hospitalized COVID-19 patient.
Read the detailed description
PURPOSE: There is clinical equipoise around the safety and efficacy of ARBs in COVID-19, but there are few RCTs of ARBs in COVID-19. Guo and colleagues' meta-analysis showed that ARBs/ACE inhibitor use was associated with decreased mortality. Our structured literature review (Cheng et al., submitted) shows that SARS-CoV-2 and other viruses that bind ACE2 cause acute cardiac injury in nearly 50% of cases. Safety concerns of ARBs in COVID-19 arise because ARBs increase cardiac ACE2, potentially increasing SARS-CoV-2 cellular uptake and worsening outcomes. On the other hand, ARBs block the effects of excess angiotensin II and could be beneficial. Our proposed ARBs CORONA II Phase 3 RCT will establish whether ARBs can decrease mortality in hospitalized COVID-19 patients.
HYPOTHESIS:
Primary - ARBs (losartan, valsartan, azilsartan, candesartan, eprosartan, irbesartan, olmesartan, telmisartan) decreases mortality and are safe in hospitalized COVID-19 infected adults compared to standard of care.
Secondary - ACE pathway proteins (ATI, AT1-7, ATII, ACE and ACE2 levels), cytokines and metabolomics/proteomics predict mortality and efficacy of ARBs in hospitalized COVID19 adults.
RESEARCH DESIGN: Study will assess ARBs (losartan, valsartan, azilsartan, candesartan, eprosartan, irbesartan, olmesartan, telmisartan) (see 6.3 Intervention for more) vs. usual care for safety and efficacy in decreasing organ dysfunction and mortality of hospitalized adults with COVID-19. Dr. Srinivas Murthy and Dr Rob Fowler, co-investigators herein and PIs of the CATCO RCT in Canada, Dr. John Marshall, co-investigator herein and PI of REMAPCAP, and Dr. Russell have coordinated alignment by allowing co-enrollment and harmonization of data and sample collection and primary endpoints.
- Conditions
- Covid19, SARS-CoV Infection
- Being tested
- Losartan, Valsartan, Azilsartan, Candesartan, Eprosartan
- Keywords
- ARBs, angiotensin II type 1 receptor blocker, ACEi, acute respiratory distress syndrome, COVID-19, coronavirus, multisite, Global, Canada, Acute kidney injury, acute cardiac injury, shock
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome, Respiratory Distress Syndrome, Coronavirus Infections, Acute Kidney Injury, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Also called Cozaar
Oral losartan 25 mg, stepped up to 50 mg and then up to 100 mg peak dose, as tolerated.
ValsartanDrug
Also called Diovan
Oral Valsartan 40 mg, stepped up to 80 mg and then up to 160 mg peak dose, as tolerated.
AzilsartanDrug
Also called Edarbi
Oral Azilsartan 40 mg, and stepped up to 80 mg.
CandesartanDrug
Also called Atacand
Oral Candesartan 8 mg, stepped up to 16 mg and then up to 32 mg peak dose, as tolerated.
EprosartanDrug
Also called Teventen
Oral Eprosartan 400 mg, stepped up to 600 mg and then up to 800 mg peak dose, as tolerated.
IrbesartanDrug
Also called Avapro
Oral Irbesartan 75 mg, stepped up to 150 mg and then up to 300 mg peak dose, as tolerated.
OlmesartanDrug
Also called Olmetec
Oral Olmesartan 10 mg, stepped up to 20 mg and then up to 40 mg peak dose, as tolerated.
TelmisartanDrug
Also called Micardis
Oral Azilsartan 40 mg, and stepped up to 80 mg.
| Study group | Role | What they receive |
|---|---|---|
| ARBs (Losartan, Valsartan, Azilsartan, Candesartan, Eprosartan, Irbesartan, Olmesartan, Telmisartan) | Experimental | Patients will initially receive initial dose of oral ARBs, increased to higher dose after 24 hours and then increased to a max dose after another 24 hours, dependent on tolerance. Patient will remain at dose for duration of hospital (max of 3 months if still hospitalized). Tolerance is defined as having no severe adverse events 24 hours after the first dose. Investigators and/or attending physicians discretion may dictate that dose will not be increased, at which point dose will stay at initial or higher dose. Receives: Drug: Losartan; Drug: Valsartan; Drug: Azilsartan; Drug: Candesartan; Drug: Eprosartan; Drug: Irbesartan; Drug: Olmesartan; Drug: Telmisartan |
| Usual Care Control | No intervention | Usual care for duration of hospitalization for up to 3 months if still hospitalized. Due to the lack of clinical guidance from this emergent disease, this may vary dependent on Institution and/or country |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Survival status
Measured: 28 days
Secondary outcomes (7)
Hospital Mortality
Survival status
Measured: up to 6 months
ICU Admission
Location within hospital (ICU or wards)
Measured: up to 6 months
Days alive and free of vasopressors, ventilation, and renal replacement therapy
Survival and ICU support status
Measured: up to 14 days
SOFA score
Sequential Organ Failure Assessment (SOFA) score
Measured: 28 days
Acute cardiac injury
Use of inotropic agents and increase(s) of of troponin and/or NT-proBNP from admission level
Measured: 6 months
Severe adverse events
Severe adverse effects of ARBs and mortality
Measured: 6 months
Mortality
Survival status
Measured: at 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start9 Oct 2020
- Primary completion22 Apr 2022
- Study completion22 Apr 2022
Why it stopped: DSMC recommendation due to futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Jim Russell, University of British Columbia
- Investigators
- James A Russell, MD, Principal investigator, University of British ColumbiaKaren Tran, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606563
- Sponsor's protocol ID
- H20-01984
- Acronym
- ARBs CORONA II
- Status last verified
- Feb 2023
- First submitted
- 27 Oct 2020
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tran KC, Asfar P, Cheng M, Demiselle J, Singer J, Lee T, Sweet D, Boyd J, Walley K, Haljan G, Sharif O, Geri G, Auchabie J, Quenot JP, Lee TC, Tsang J, Meziani F, Lamontagne F, Dubee V, Lasocki S, Ovakim D, Wood G, Turgeon A, Cohen Y, Lebas E, Goudelin M, Forrest D, Teale A, Mira JP, Fowler R, Daneman N, Adhikari NKJ, Gousseff M, Leroy P, Plantefeve G, Rispal P, Courtois R, Winston B, Reynolds S, Birks P, Bienvenu B, Tadie JM, Talarmin JP, Ansart S, Russell JA; ARBs CORONA II Team. Effects of Losartan on Patients Hospitalized for Acute COVID-19: A Randomized Controlled Trial. Clin Infect Dis. 2024 Sep 26;79(3):615-625. doi: 10.1093/cid/ciae306.
PubMed 39325643
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan and Other ARBs on Outcomes of Coronavirus Infection?
- ClinicalTrials.gov ID
- NCT04606563
- Acronym / sponsor ID
- ARBs CORONA II / H20-01984
- Conditions
- Covid19, SARS-CoV Infection
- Keywords
- ARBs, angiotensin II type 1 receptor blocker, ACEi, acute respiratory distress syndrome, COVID-19, coronavirus, multisite, Global
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMC recommendation due to futility
- Enrolment
- 341 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 28 Oct 2020 (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.
SARS-CoV-2 is a member of a class of viruses: angiotensin converting enzyme 2 (ACE2)-binding viruses that study calls "ABVs". The World Health Organization (WHO) and others are performing randomized controlled trials (RCTs) of vaccines and novel antivirals to address SARS-CoV-2 directly. However, the critical illness complications of COVID-19 are caused in part by SARS-CoV-2's binding and inhibiting ACE2 and the consequent host response.
ACE 2 is the receptor for H1N1, H5N1, and SARS-CoV-2. After binding ACE2, SARS-CoV-2 is endocytosed, and surface ACE2 is down-regulated, increasing angiotensin II (ATII a potent vasoconstrictor) in COVID-19. The original ARBs limits lung injury in murine influenza H7N9 and decreases viral titre and RNA.
Study has a unique opportunity to complement vaccine and anti-viral RCTs with an RCT modulating the host response using an angiotensin II type 1 receptor blocker (ARBs) to decrease the mortality of hospitalized COVID-19 patient.
Detailed description
PURPOSE: There is clinical equipoise around the safety and efficacy of ARBs in COVID-19, but there are few RCTs of ARBs in COVID-19. Guo and colleagues' meta-analysis showed that ARBs/ACE inhibitor use was associated with decreased mortality. Our structured literature review (Cheng et al., submitted) shows that SARS-CoV-2 and other viruses that bind ACE2 cause acute cardiac injury in nearly 50% of cases. Safety concerns of ARBs in COVID-19 arise because ARBs increase cardiac ACE2, potentially increasing SARS-CoV-2 cellular uptake and worsening outcomes. On the other hand, ARBs block the effects of excess angiotensin II and could be beneficial. Our proposed ARBs CORONA II Phase 3 RCT will establish whether ARBs can decrease mortality in hospitalized COVID-19 patients.
HYPOTHESIS:
Primary - ARBs (losartan, valsartan, azilsartan, candesartan, eprosartan, irbesartan, olmesartan, telmisartan) decreases mortality and are safe in hospitalized COVID-19 infected adults compared to standard of care.
Secondary - ACE pathway proteins (ATI, AT1-7, ATII, ACE and ACE2 levels), cytokines and metabolomics/proteomics predict mortality and efficacy of ARBs in hospitalized COVID19 adults.
RESEARCH DESIGN: Study will assess ARBs (losartan, valsartan, azilsartan, candesartan, eprosartan, irbesartan, olmesartan, telmisartan) (see 6.3 Intervention for more) vs. usual care for safety and efficacy in decreasing organ dysfunction and mortality of hospitalized adults with COVID-19. Dr. Srinivas Murthy and Dr Rob Fowler, co-investigators herein and PIs of the CATCO RCT in Canada, Dr. John Marshall, co-investigator herein and PI of REMAPCAP, and Dr. Russell have coordinated alignment by allowing co-enrollment and harmonization of data and sample collection and primary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARBs (Losartan, Valsartan, Azilsartan, Candesartan, Eprosartan, Irbesartan, Olmesartan, Telmisartan) | Experimental | Drug: Losartan, Drug: Valsartan, Drug: Azilsartan, Drug: Candesartan, Drug: Eprosartan, Drug: Irbesartan, Drug: Olmesartan, Drug: TelmisartanPatients will initially receive initial dose of oral ARBs, increased to higher dose after 24 hours and then increased to a max dose after another 24 hours, dependent on tolerance. Patient will remain at dose for duration of hospital (max of 3 months if still hospitalized). Tolerance is defined as having no severe adverse events 24 hours after the first dose. Investigators and/or attending physicians discretion may dictate that dose will not be increased, at which point dose will stay at initial or higher dose. |
| Usual Care Control | No intervention | –Usual care for duration of hospitalization for up to 3 months if still hospitalized. Due to the lack of clinical guidance from this emergent disease, this may vary dependent on Institution and/or country |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hospitalized
- Must be first admission of COVID-19, not re-admission
- Primary reason for hospitalization or prolonged hospitalization is because of acute COVID-19 diagnosis
- Adults 18 years of age or greater
- Laboratory-proven COVID-19 within 14 days prior to hospital admission
Key exclusion criteria (9 listed)
- Hypotension (SAP < 100 mmHg or DAP < 50 mmHg or MAP < 65 mmHg)
- Hyperkalemia (> 5.5 mmol/l)
- Acute kidney injury (urine output < 0.5 ml/kg/hr and new creatinine > 200 mmol/l, or increase > 100 mmol/l, or GFR < 30 ml/min)
- Use of aliskiren in patients with diabetes mellitus (type 1 or type 2) or moderate-severe renal impairment (GFR less than 60mL/min)
- Use of ARB/ACEi within 7 days of presentation
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 |
|---|---|---|
| LosartanAlso: CozaarOral losartan 25 mg, stepped up to 50 mg and then up to 100 mg peak dose, as tolerated. | Drug | ARBs (Losartan, Valsartan, Azilsartan, Candesartan, Eprosartan, Irbesartan, Olmesartan, Telmisartan) |
| ValsartanAlso: DiovanOral Valsartan 40 mg, stepped up to 80 mg and then up to 160 mg peak dose, as tolerated. | Drug | ARBs (Losartan, Valsartan, Azilsartan, Candesartan, Eprosartan, Irbesartan, Olmesartan, Telmisartan) |
| AzilsartanAlso: EdarbiOral Azilsartan 40 mg, and stepped up to 80 mg. | Drug | ARBs (Losartan, Valsartan, Azilsartan, Candesartan, Eprosartan, Irbesartan, Olmesartan, Telmisartan) |
| CandesartanAlso: AtacandOral Candesartan 8 mg, stepped up to 16 mg and then up to 32 mg peak dose, as tolerated. | Drug | ARBs (Losartan, Valsartan, Azilsartan, Candesartan, Eprosartan, Irbesartan, Olmesartan, Telmisartan) |
| EprosartanAlso: TeventenOral Eprosartan 400 mg, stepped up to 600 mg and then up to 800 mg peak dose, as tolerated. | Drug | ARBs (Losartan, Valsartan, Azilsartan, Candesartan, Eprosartan, Irbesartan, Olmesartan, Telmisartan) |
| IrbesartanAlso: AvaproOral Irbesartan 75 mg, stepped up to 150 mg and then up to 300 mg peak dose, as tolerated. | Drug | ARBs (Losartan, Valsartan, Azilsartan, Candesartan, Eprosartan, Irbesartan, Olmesartan, Telmisartan) |
| OlmesartanAlso: OlmetecOral Olmesartan 10 mg, stepped up to 20 mg and then up to 40 mg peak dose, as tolerated. | Drug | ARBs (Losartan, Valsartan, Azilsartan, Candesartan, Eprosartan, Irbesartan, Olmesartan, Telmisartan) |
| TelmisartanAlso: MicardisOral Azilsartan 40 mg, and stepped up to 80 mg. | Drug | ARBs (Losartan, Valsartan, Azilsartan, Candesartan, Eprosartan, Irbesartan, Olmesartan, Telmisartan) |
Primary outcome
Mortality
Time frame: 28 days
Survival status
7 secondary outcomes
Hospital Mortality
Time frame: up to 6 months
ICU Admission
Time frame: up to 6 months
Days alive and free of vasopressors, ventilation, and renal replacement therapy
Time frame: up to 14 days
SOFA score
Time frame: 28 days
Acute cardiac injury
Time frame: 6 months
Severe adverse events
Time frame: 6 months
Mortality
Time frame: at 1, 3 and 6 months
Results and safety
The study was stopped early (reason given: DSMC recommendation due to futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Derived from this study: PubMed 39325643Tran KC, Asfar P, Cheng M, Demiselle J, Singer J, Lee T, Sweet D, Boyd J, Walley K, Haljan G, Sharif O, Geri G, Auchabie J, Quenot JP, Lee TC, Tsang J, Meziani F, Lamontagne F, Dubee V, Lasocki S, Ovakim D, Wood G, Turgeon A, Cohen Y, Lebas E, Goudelin M, Forrest D, Teale A, Mira JP, Fowler R, Daneman N, Adhikari NKJ, Gousseff M, Leroy P, Plantefeve G, Rispal P, Courtois R, Winston B, Reynolds S, Birks P, Bienvenu B, Tadie JM, Talarmin JP, Ansart S, Russell JA; ARBs CORONA II Team. Effects of Losartan on Patients Hospitalized for Acute COVID-19: A Randomized Controlled Trial. Clin Infect Dis. 2024 Sep 26;79(3):615-625. doi: 10.1093/cid/ciae306.
- Individual participant dataSharing planned: No
Related trials for Covid19
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
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
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
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.
James A Russell, MD principal investigator
University of British Columbia
Karen Tran, MD principal investigator
University of British Columbia
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Losartan, Valsartan and Azilsartan in people with Covid19 and SARS-CoV Infection, run by University of British Columbia at 13 sites in 2 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 5 inclusion and 9 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 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada, France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: DSMC recommendation due to futility). 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?
Mortality (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 NCT04606563, which also lists 1 linked publication.
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 16 Feb 2023.