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Invasive Mould InfectionPhase 2NCT07215273

Phase 2 EL219 Versus Liposomal Amphotericin B or Voriconazole for Early Antifungal Therapy

A Phase 2 study testing EL219 and Active Comparator- IV Antifungal (LAmB or voriconazole) in people with Invasive Mould Infection, run by Elion Therapeutics, Inc. at 30 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to determine if EL219 is safe and effective compared to liposomal amphotericin B (LAmB) or voricanozole for early treatment of invasive mould infections Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Invasive Mould Infection
What is being tested?
EL219 and Active Comparator- IV Antifungal (LAmB or voriconazole)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
30 sitesin 6 countries
Study dates
13 Feb 2026to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Participants who meet ALL the following inclusion criteria will be eligible to participate in the study:
  • Willing and able to provide written informed consent.
  • 18 years and older, of any gender, race, or ethnicity
  • Are at risk for invasive fungal infections (IFIs), by virtue of acquired or inherited immunocompromising condition including but not limited to the following:
  • Receipt of a blood or marrow transplant (BMT) from an allogeneic donor
  • Active hematologic malignancy.
Show all 21Show fewer
  • Recent neutropenia with absolute neutrophil count <500 cells/mm3 >10 days
  • Receipt of corticosteroids at mean minimum doses of 0.3 mg/kg/day prednisone equivalent for >3 weeks.
  • Receipt of other recognized T-cell immunosuppressants, such as cyclosporin, tumor necrosis factor alpha (TNF-α) blockers, or specific monoclonal antibodies during the last 3 months.
  • Inherited severe immunodeficiency
  • Has suspected or confirmed mould infection (IMI) supported by one or both of the following:
  • Results of an assay having regulatory clearance in Europe or the United States (Conformité Européene [CE] mark or United States Food and Drug Administration [US FDA] 510k clearance), demonstrating positivity at validated cut-off that is suggestive of IMI. Diagnostic tests must have regulatory approval in the region in which the diagnostic is performed and are inclusive of Platelia serum or bronchoalveolar lavage (BAL) galactomannan, serum or BAL polymerase chain reaction (PCR), serum or BAL Aspergillus antigen lateral flow assays (LFAs; IMMY, OLM Diagnostics, or TECO®), or urine MycoMEIA®-Aspergillus assay
  • Abnormal findings on chest computed tomography (CT) scan without alternative microbiologic diagnosis Note: If CT of the chest is used to establish eligibility it must be performed within 7 days prior to randomization.
  • Must have IV access in place or to be placed prior to beginning IV study therapy.
  • Must be willing to adhere to dosing, study visit schedule, and mandatory diagnostic procedures.
  • Female participants must meet 1 of the following criteria:
  • A woman of childbearing potential (WOCBP) must agree to use a highly effective, preferably user-independent method of contraception (failure rate of <1% per year when used consistently and correctly) for at least 30 days prior to screening and agree to remain on a highly effective method until 2 months after study drug administration.
  • A female of non-childbearing potential must be surgically sterile (i.e., have undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion without reversal surgery) or in a menopausal state (at least 2 years without menses), or confirmation of menopause by follicle-stimulating hormone (FSH) levels (≥40 mIU/mL).
  • A WOCBP must have a negative pregnancy test (highly sensitive serum β-human chorionic gonadotropin or a urine test) during both the current hospitalization AND on Day -1 before study drug administration.
  • Females must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of at least 2 months after study drug administration.
  • Male participants must be vasectomized or agree to abstain from intercourse or if engaging in sexual activity that has risk of pregnancy, must agree to use a double barrier method (e.g. condom and spermicide) and agree not to donate sperm during the study and for at least 120 days after study drug administration.

Who cannot join

  • Participants must NOT meet any of the following exclusion criteria:
  • Participant has received prior antifungal treatment (azole or echinocandin prophylaxis permitted) for >96 hours prior to randomization.
  • Active, microbiologically confirmed systemic bacterial infection with ongoing receipt of antibacterial therapy. Antibacterial prophylaxis and secondary therapy is allowed, providing that follow-up cultures have been without growth for >2 days.
  • Participants with 1 or more of the following laboratory abnormalities as defined by the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v5.0:
  • Alanine aminotransferase (ALT) ≥5 × upper limit of normal (ULN).
  • Total serum bilirubin ≥5 × ULN (excluding Gilbert's Syndrome).
Show all 23Show fewer
  • Serum creatinine ≥2 mg/dL or creatinine clearance (CrCL) ≤30 mL/minute.
  • Known cirrhosis of the liver, diagnosed according to country or Medical Society-specific guidelines and documented in the medical records prior to screening.
  • Known New York Heart Association (NYHA) Class III or Class IV heart failure.
  • Diagnosed reduced lung function with either diffusion capacity (corrected for hemoglobin) or forced expiratory volume in 1 second (FEV1) ≤65% of predicted value, or oxygen (O2) saturation ≤82% on room air.
  • Receiving either hemodialysis or peritoneal dialysis.
  • Personal or family history of long QT interval on ECG (QT) syndrome or a prolonged QT interval corrected for heart rate by Fridericia's formula (QTcF; >470 msec in males and >490 msec in females).
  • If the Investigator chooses voriconazole as Comparator therapy, current or projected use of the following medications or drug classes known to interact with voriconazole: terfenadine, astemizole, cisapride, pimozide, quinidine, sirolimus, rifampin, phenytoin, carbamazepine, flucloxacillin, eplerenone, fineronone, voclosporin, ritonavir or other protease inhibitors, efavirenz, venetoclax or other non-nucleoside reductase inhibitors, rifabutin, naloxegol, tolvaptan, ivabradine, lurasidone, St. John's Wort, ergot alkaloids, or long-acting barbiturates.
  • If the Investigator chooses voriconazole as Comparator therapy, history of hereditary problems with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  • Known hypersensitivity to EL219 Powder for Injection, polyenes, or known hypersensitivity to voriconazole if the Investigator chooses voriconazole as Comparator therapy.
  • History of severe allergic response to mRNA-based severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine and/or polyethylene glycol (PEG)-containing products.
  • Previous participation in any study using an investigational drug within 5 half-lives of the drug, or intention to use investigational drug before completion of the Day 56 Safety Follow-Up. Concurrent participation in another trial may be allowed (e.g., interventional trial with a previously approved study drug[s] or observational trial). In such cases, the Medical Monitor should be consulted prior to enrolling a potential participant.
  • Prior recipient of orthotopic lung transplant.
  • Imminent transition to hospice or withdrawn care such as with refractory malignancy or multiorgan failure.
  • Female participants who are pregnant or lactating or planning to become pregnant within 2 months following study drug administration.
  • The Principal Investigator (PI) determines the participant should not participate in the study.
  • Considered unlikely to follow up for required days due to logistic concerns (i.e., home location relative to study site).
  • Persons committed to an institution by virtue of an order issued either by the judicial or the administrative authorities or are in a dependent relationship with the Sponsor or the Investigator.

Trial locations and contacts

30 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Laura A. Navalta contact

443-423-1785

info@eliontx.com

Gordana Schnider, MHA contact

443-423-1785

info@eliontx.com

30 sites in 6 countries

United States11 sites, 11 recruiting

  • U. of Michigan

    Ann Arbor, Michigan, 48109

    Recruiting

  • Augusta University Medical Center

    Augusta, Georgia, 30912

    Recruiting

  • John Hopkins University

    Baltimore, Maryland, 21287

    Recruiting

  • U. of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02446

    Recruiting

  • U. of Texas, MD Anderson

    Houston, Texas, 77030

    Recruiting

  • UC Davis Medical Center

    Sacramento, California, 95817

    Recruiting

  • U. of Texas Health Sciences Center at San Antonio

    San Antonio, Texas, 78229-3900

    Recruiting

  • U. of Washington

    Seattle, Washington, 98109

    Recruiting

  • Washington U.

    St Louis, Missouri, 63110

    Recruiting

Other trials in United States

Spain6 sites, 6 recruiting

  • Hospital del Mar

    Barcelona, 08024

    Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

    Recruiting

  • Hospital Clinic Barcelona

    Barcelona, 08036

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hospital Universitario Puerta de Hierro

    Majadahonda, 28222

    Recruiting

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007

    Recruiting

Other trials in Spain

Belgium5 sites, 5 recruiting

  • AZ Sint-Jan Brugge

    Bruges, 8000

    Recruiting

  • Universite Libre de Bruxelles (ULB) - Institut Jules Bordet

    Brussels, 1070

    Recruiting

  • UZ Gent

    Ghent, 9000

    Recruiting

  • UZ Leuven

    Leuven, 3000

    Recruiting

  • Centre Hospitalier Universitaire (CHU) de Liege

    Liège, 4000

    Recruiting

Other trials in Belgium

Canada3 sites, 3 recruiting

  • Juravinski Hospital

    Hamilton, Ontario, L8V 1C3

    Recruiting

  • University Health Network (UHN) - Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2N2

    Recruiting

  • Vancouver General Hospital

    Vancouver, British Columbia, V6T 2B5

    Recruiting

Other trials in Canada

France3 sites, 3 recruiting

  • Centre Hospitalier d'Argenteuil

    Argenteuil, 95107

    Recruiting

  • AP-HP Hopital Henri Modor

    Créteil, 94000

    Recruiting

  • AP-HP Hopital Saint-Louis

    Paris, 75010

    Recruiting

Other trials in France

Italy2 sites, 2 recruiting

  • Istituto Europeo di Oncologia

    Milan, 20141

    Recruiting

  • Fondazione Policlinico Universitario A. Gemelli IRCCS- Universita Cattolica del Sacro Cuore

    Roma, 00168

    Recruiting

Other trials in Italy

About this study

Official title: A Phase 2, Multicenter, Randomized, Double-blind Study of Safety and Efficacy of EL219 (Turletricin) Versus Liposomal Amphotericin B or Voriconazole for Early Antifungal Therapy of Invasive Mould Infections (TREAT-1)

The purpose of this study is to determine if EL219 is safe and effective compared to liposomal amphotericin B (LAmB) or voricanozole for early treatment of invasive mould infections

Read the detailed description

A Phase 2, multicenter, randomized, double-blind Study of Safety and Efficacy of EL219 versus Comparator (LAmB or voriconazole) for early antifungal therapy of suspected or confirmed Invasive Mould Infections (IMI)

Being tested
EL219, Active Comparator- IV Antifungal (LAmB or voriconazole)
Keywords
Invasive Mould Infection, Mould infection, Prophylaxis for Invasive Mould Infection, Anti-fungal therapy, Invasive Mold Infection, Mold infection, Prophylaxis for Invasive Mold Infection, Early antifungal therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EL219Drug

    Also called Formerly SF001, Now EL219 (Turletricin)

    EL219 is specifically being developed for early antifungal therapy (EAT), when infection is suspected due to highly suggestive signs and symptoms of disease; in high-risk people, antifungals are recommended even before confirmation of the microbial cause of infection, because delayed therapy is associated with poor outcomes in those who lack adequate immune responses. EL219 may provide a once-weekly alternative to LAmB and other polyenes that could also reduce the toxicities that often limit the frequency and duration of administration for these highly efficacious antifungals.

  • Active Comparator- IV Antifungal (LAmB or voriconazole)Drug

    Also called Liposomal Amphotericin B or Voriconazole

    LAmB has broad-spectrum activity but its use is limited by toxicity and once-daily IV administration. It is not administered outside of the monitored setting given risks for electrolyte disturbances and cardiac arrhythmias. Voriconazole is a first-line therapy for IA and the most common azole used in the US and globally but does not have activity against many non-Aspergillus moulds.

Study groups in NCT07215273
Study groupRoleWhat they receive
EL219ExperimentalParticipants randomized to EL219 will receive a single loading dose of EL219 at 2 mg/kg via IV infusion on Day 1, and 1.5 mg/kg IV infusions on Days 8, 15, 22, 29, and 36. All dosing calculations for EL219 will be based on total body weight (TBW). To maintain the blind, placebo IV infusions will be administered to participants randomized to EL219 arm daily (corresponding to Liposomal Amphotericin B (LAmB) dosing); or 2x daily (corresponding to voriconazole dosing depending on the Investigator's choice of Comparator).
Receives: Drug: EL219
Antifungal ComparatorActive comparatorComparator arm (CMPTR) will receive LAmB 3mg/kg once daily IV infusions for min.14 days \& up to 42 days. Participants w/suspected or diagnosed mucormycosis may be dosed at 5mg/kg. Voriconazole (Vori) 6mg/kg BID IV loading dose on Day 1 followed by 4mg/kg IV BID thereafter. Dosing calculations for LAmB \& vori are based on TBW. Participants may switch from CMPTR to optional SOC antifungals (PI discretion) if any of these occur: Toxicity; serum creatinine 2×baseline (bsln) level or 50% reduction in GFR, Hypokalemia or hypomagnesemia not controlled with IV supplementation, increase in ALT to 3×bsln and/or total bili 3×bsln, intractable IRR •Imminent hosp discharge requiring switch from CMPTR •Intolerable clinical s/s consistent w/known drug-related effect •Dx by C\&S testing suggesting IMI not appropriately treated w/1 or both CMPTR drug Vori trough level <2.0 or >5.5mg/L for whom vori was selected as the randomized CMPTR
Receives: Drug: Active Comparator- IV Antifungal (LAmB or voriconazole)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Outcome/Measure All-Cause Mortality

    All-cause mortality at Day 21 (plus or minus 3 days) in the Intent-to-Treat (ITT) analysis set.

    Measured: From enrollment to Day 21

  2. Primary Outcome/Measure SAE TEAE

    During the blinded portion of the study, serious adverse events and treatment-emergent adverse events categorized in a tiered approach in the Safety analysis set. Tier 1 TEAEs include renal, electrolyte, hepatic, infusion-related reactions, photophobia and photosensitivity. Tier 2 includes all other TEAEs.

    Measured: From enrollment to the end of treatment at Day 42

Secondary outcomes (3)

  1. Secondary Outcome Measure-EAT Success

    Early antifungal therapy (EAT) success at Day 21 (plus or minus 3 days) in the ITT analysis set defined by non-occurrence of the following: death, cessation of study antifungals for progression of IMI, and/or toxicity, missing data (classified as indeterminate but analyzed as a failure).

    Measured: From enrollment through Day 21

  2. Secondary Outcome Measure-Overall Success

    Overall success at Day 42 (plus or minus 7 days) confirmed by the Data Review Committee, in the population with proven or probable IA (modified Intent-to-Treat)

    Measured: From enrollment through Day 42

  3. Secondary Outcome Measure-Participant is Alive

    Participant is alive, favorable composite clinical, mycologic, and radiographic response (European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group [EORTC/MSG] criteria)

    Measured: From enrollment through Day 42

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2025
  2. Study start13 Feb 2026
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07215273
Sponsor's protocol ID
EL219.IV.2.04
Status last verified
May 2026
First submitted
24 Sep 2025
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: It is not yet known if there will be a plan to make IPD available.

Publications

  • Adler-Moore J, Lewis RE, Bruggemann RJM, Rijnders BJA, Groll AH, Walsh TJ. Preclinical Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antifungal Activity of Liposomal Amphotericin B. Clin Infect Dis. 2019 May 2;68(Suppl 4):S244-S259. doi: 10.1093/cid/ciz064.

    PubMed 31222254

  • AmBisome® (amphotericin B) liposome for injection [Prescribing Information]. Foster City, CA: Gilead Sciences, Inc.; 2022.

  • AmBisome Liposomal 50 mg Powder for dispersion for infusion [Summary of Product Characteristics]. Foster City, CA: Gilead Sciences, Inc.; May 2024.

  • Anderson TM, Clay MC, Cioffi AG, Diaz KA, Hisao GS, Tuttle MD, Nieuwkoop AJ, Comellas G, Maryum N, Wang S, Uno BE, Wildeman EL, Gonen T, Rienstra CM, Burke MD. Amphotericin forms an extramembranous and fungicidal sterol sponge. Nat Chem Biol. 2014 May;10(5):400-6. doi: 10.1038/nchembio.1496. Epub 2014 Mar 30.

    PubMed 24681535

  • Bowden R, Chandrasekar P, White MH, Li X, Pietrelli L, Gurwith M, van Burik JA, Laverdiere M, Safrin S, Wingard JR. A double-blind, randomized, controlled trial of amphotericin B colloidal dispersion versus amphotericin B for treatment of invasive aspergillosis in immunocompromised patients. Clin Infect Dis. 2002 Aug 15;35(4):359-66. doi: 10.1086/341401. Epub 2002 Jul 25.

    PubMed 12145716

  • Burke MD, He X, Cook C, Petrov GA, Long S, Coffin MD. Stability enhancement of drug layered pellets in a fixed dose combination tablet. AAPS PharmSciTech. 2013 Mar;14(1):312-20. doi: 10.1208/s12249-012-9911-3. Epub 2013 Jan 15.

    PubMed 23319298

  • Chamilos G, Luna M, Lewis RE, Chemaly R, Raad II, Kontoyiannis DP. Effects of liposomal amphotericin B versus an amphotericin B lipid complex on liver histopathology in patients with hematologic malignancies and invasive fungal infections: a retrospective, nonrandomized autopsy study. Clin Ther. 2007 Sep;29(9):1980-6. doi: 10.1016/j.clinthera.2007.09.016.

    PubMed 18035197

  • Cornely OA, Maertens J, Bresnik M, Ebrahimi R, Dellow E, Herbrecht R, Donnelly JP. Efficacy outcomes in a randomised trial of liposomal amphotericin B based on revised EORTC/MSG 2008 definitions of invasive mould disease. Mycoses. 2011 Sep;54(5):e449-55. doi: 10.1111/j.1439-0507.2010.01947.x. Epub 2010 Oct 11.

    PubMed 21039936

  • Cornely OA, Maertens J, Bresnik M, Ebrahimi R, Ullmann AJ, Bouza E, Heussel CP, Lortholary O, Rieger C, Boehme A, Aoun M, Horst HA, Thiebaut A, Ruhnke M, Reichert D, Vianelli N, Krause SW, Olavarria E, Herbrecht R; AmBiLoad Trial Study Group. Liposomal amphotericin B as initial therapy for invasive mold infection: a randomized trial comparing a high-loading dose regimen with standard dosing (AmBiLoad trial). Clin Infect Dis. 2007 May 15;44(10):1289-97. doi: 10.1086/514341. Epub 2007 Apr 9.

    PubMed 17443465

  • Davis SA, Vincent BM, Endo MM, Whitesell L, Marchillo K, Andes DR, Lindquist S, Burke MD. Nontoxic antimicrobials that evade drug resistance. Nat Chem Biol. 2015 Jul;11(7):481-7. doi: 10.1038/nchembio.1821. Epub 2015 Jun 1.

    PubMed 26030729

  • Donnelly JP, Chen SC, Kauffman CA, Steinbach WJ, Baddley JW, Verweij PE, Clancy CJ, Wingard JR, Lockhart SR, Groll AH, Sorrell TC, Bassetti M, Akan H, Alexander BD, Andes D, Azoulay E, Bialek R, Bradsher RW, Bretagne S, Calandra T, Caliendo AM, Castagnola E, Cruciani M, Cuenca-Estrella M, Decker CF, Desai SR, Fisher B, Harrison T, Heussel CP, Jensen HE, Kibbler CC, Kontoyiannis DP, Kullberg BJ, Lagrou K, Lamoth F, Lehrnbecher T, Loeffler J, Lortholary O, Maertens J, Marchetti O, Marr KA, Masur H, Meis JF, Morrisey CO, Nucci M, Ostrosky-Zeichner L, Pagano L, Patterson TF, Perfect JR, Racil Z, Roilides E, Ruhnke M, Prokop CS, Shoham S, Slavin MA, Stevens DA, Thompson GR, Vazquez JA, Viscoli C, Walsh TJ, Warris A, Wheat LJ, White PL, Zaoutis TE, Pappas PG. Revision and Update of the Consensus Definitions of Invasive Fungal Disease From the European Organization for Research and Treatment of Cancer and the Mycoses Study Group Education and Research Consortium. Clin Infect Dis. 2020 Sep 12;71(6):1367-1376. doi: 10.1093/cid/ciz1008.

    PubMed 31802125

  • Empiric antifungal therapy in febrile granulocytopenic patients. EORTC International Antimicrobial Therapy Cooperative Group. Am J Med. 1989 Jun;86(6 Pt 1):668-72. doi: 10.1016/0002-9343(89)90441-5.

    PubMed 2658574

  • European Medicines Agency. Good practice guide on recording, coding, reporting, and assessment of medication errors (EMA/762563/2014). 2015.

  • Clinical Trials Regulation (EU) No. 536/2014 of the European Parliament and the Council of 16 April 2014 on Clinical Trials on Medicinal Products for Human Use, and Repealing Directive 2001/20/EC Text with EEA relevance - Annex III.

  • Fiorcari S, Maffei R, Vallerini D, Scarfo L, Barozzi P, Maccaferri M, Potenza L, Ghia P, Luppi M, Marasca R. BTK Inhibition Impairs the Innate Response Against Fungal Infection in Patients With Chronic Lymphocytic Leukemia. Front Immunol. 2020 Aug 28;11:2158. doi: 10.3389/fimmu.2020.02158. eCollection 2020.

    PubMed 32983178

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EL219 and Active Comparator- IV Antifungal (LAmB or voriconazole) in people with Invasive Mould Infection, run by Elion Therapeutics, Inc. at 30 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 21 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Spain, Belgium, Canada, France 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Laura A. Navalta (443-423-1785, info@eliontx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome/Measure All-Cause Mortality (time frame: From enrollment to Day 21). The study lists 2 primary outcomes in all. 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 NCT07215273, which also lists 56 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 27 Oct 2026.

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