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Invasive AspergillosisPhase 3OASISNCT05101187

Olorofim Aspergillus Infection Study

A Phase 3 study testing Olorofim and AmBisome® in people with Invasive Aspergillosis, run by F2G Ltd at 143 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or probable lower respiratory tract disease Aspergillus species (invasive aspergillosis, IA). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Invasive Aspergillosis
What is being tested?
Olorofim and AmBisome®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
225 participants
Where
143 sitesin 21 countries
Study dates
29 Apr 2022to 19 Mar 2026
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

  • Male and female patients ages over 18 years and weighing more than 30 kg
  • Patients with proven IA at any site or probable LRTD IA per EORTC/MSG 2019 criteria as adapted for this study and where the duration of specific therapy for this episode of IA has been ≤ 28 days. For purposes of this inclusion, the duration of specific therapy includes any mould-active therapy given for this episode of IA whether subsequently judged potentially effective or not.
  • Patients requiring therapy with an antifungal agent other than a mould-active azole, and who have had ≤ 96 hours of potentially effective prior therapy. Potentially effective prior therapy includes any agent to which the infecting strain of Aspergillus is likely to be susceptible. There are no exclusions or limitations on such agents (eg, AmBisome® is permitted) other than their duration.
  • AmBisome® is an appropriate therapy for the patient.

Who cannot join

  • Women who are pregnant or breastfeeding.
  • Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug
  • Patients with only chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
  • Suspected mucormycosis (zygomycosis).
  • Patients with a known active second fungal infection of any type, other than candidiasis that can be treated with fluconazole.
  • The requirement for ongoing use of echinocandin as Candida prophylaxis.
Show all 10Show fewer
  • Microbiological findings (eg, bacteriological, virological) or other potential conditions that are temporally related and suggest a different aetiology for the clinical features.
  • Human immunodeficiency virus (HIV) infection but not currently receiving antiretroviral therapy.
  • Patients with a baseline prolongation of QT using Fridericia's Correction Formula (QTcF) ≥ 500 msec, or at high risk for QT/QTc prolongation.
  • Evidence of hepatic dysfunction.

Trial locations and contacts

143 sites in 21 countries.

143 sites in 21 countries

United States24 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Augusta University

    Augusta, Georgia, 30912

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • NIH Clinical Center ,NIAID,NIH

    Bethesda, Maryland, 20892

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Duke Department of Medicine Infectious Diseases Division

    Durham, North Carolina, 27710

  • University of Florida

    Gainesville, Florida, 32610

  • Houston Methodist

    Houston, Texas, 77030

  • University of Kansas Medical Center

    Kansas City, Kansas, 64111

  • Clairvoyant Research Group, LLC

    Las Vegas, Nevada, 89119

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Rutgers RWJMS

    New Brunswick, New Jersey, 08901

  • Weill Cornell Medicine NY Presbyterian Hospital

    New York, New York, 10065

  • OU Health OU Medical Center

    Oklahoma City, Oklahoma, 73104

  • University of Pittsburgh Medical Center Health System

    Pittsburgh, Pennsylvania, 15232

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • University of California Davis Health System

    Sacramento, California, 95817

  • UCSF Helen Diller Medical Center at Parnassus Heights

    San Francisco, California, 94143

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109-1024

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

China23 sites

  • Peking University People's Hospital

    Beijing, 100033

  • Peking University Third Hospital

    Beijing, 100191

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233004

  • The First Hospital of Jilin University

    Changchun, 130021

  • Xiangya Hospital, Central South University

    Changsha, 410000

  • Chenzhou No.1 People's Hospital

    Chenzhou, 423000

  • Fujian Medical University Union Hospital

    Fuzhou, 350001

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, 510080

  • Nanfang Hospital of Southern Medical University

    Guangzhou, 510515

  • The First Affiliated Hospital of Zhejiang University school of medicine

    Hangzhou, 310003

  • Anhui Provincial Hospital

    Hefei, 230001

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, 530000

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Shengjing Hospital of China Medical University

    Shengyang, 110055

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, 50004

  • The 1st Affiliated Hosp of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Xi'an International Medical Center

    Xi'an, 710126

  • Institute of Hematology and Blood Diseases Hospital

    Xiaobailou, Tianjin Municipality, 300020

  • Henan Provincial People's Hospital

    Zhengzhou, 450003

Other trials in China

Japan13 sites

  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

    Bunkyō City, 1138677

  • Chiba University Hospital

    Chiba, Chiba, 260 8677

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812 8582

  • The Jikei University Hospital

    Minato-Ku, Tokyo, 105-8471

  • Toranomon Hospital

    Minatoku, Tokyo to, 105 8470

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852 8501

  • Okayama University Hospital

    Okayama, Okayama-ken, 700 8558

  • Osaka International Cancer Institute

    Osaka, Osaka, 541 8567

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545 8586

  • Kindai University Hospital

    Ōsaka-sayama, Osaka, 589 8511

  • Saitama Medical Center Jichi Medical University

    Saitama, 3290431

  • Tohoku University Hospital

    Sendai, Miyagi, 980 8574

  • Jichi Medical University Hospital

    Shimotsuke, 3290431

Other trials in Japan

Italy11 sites

  • IRCCS Ospedale Policlinico San Martino

    Genova, Genova, 16132

  • Ospedale San Raffaele

    Milan, Milano, 20132

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Milano, 20162

  • AOU Policlinico di Modena

    Modena, Modena, 41124

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Di Monza E Della Brianza, 20900

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli

    Naples, Campania, 80138

  • Clinica Malattie Infettive Dipartimento di Medicina e Chirurgia dell'Università

    Perugia, Perugia, 6129

  • Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)

    Pisa, PISA, 56100

  • Inmi Lazzaro Spallanzani Irccs

    Roma, Roma, 149

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 168

  • Istituto Clinico Humanitas

    Rozzano, Milano, 2089

Other trials in Italy

France9 sites

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, Doubs, 25030

  • CHU de Besancon

    Besançon, Doubs, 25030

  • CHU Bordeaux Hopital Saint André

    Bordeaux, Gironde, 33000

  • Hospital Claude Huriez

    Lille, Nord, 59037

  • CHU de Nantes CIC Hematologie

    Nantes, Loire Atlantique, 44093

  • Hôpital Necker - Enfants Malades

    Paris, Paris, 75015

  • CHU de Rennes - Hôpital Pontchaillou

    Rennes, Ille-et-Vilaine, 35000

  • Institut de Cancérologie de Strasbourg Europe - ICANS

    Strasbourg, Bas Rhin, 67200

  • Institut Universitaire du Cancer de Toulouse- IUCT-O

    Toulouse, Haute Garonne, 31059

Other trials in France

Brazil8 sites

  • Hospital Felício Rocho

    Belo Horizonte, Minas Gerais, 30110-934

  • Santa Casa de Misericórdia de Belo Horizonte

    Belo Horizonte, Minas Gerais, 30150-221

  • Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

    Curitiba, Paraná, 81520-060

  • Santa Casa de Misericórdia de Passos

    Passos, Minas Gerais, 37904-020

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital da Universidade Federal de Santa Maria CEP/UFSM

    Santa Maria, Rio Grande do Sul, 97105-900

Other trials in Brazil

Spain7 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 8036

  • Hospital Universitario Ramon y Cajal

    Madrid, Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital General Universitario Gregorio Marañón

    Retiro, Madrid, 28007

  • Hospital Universitari i Politecnic La Fe

    Valencia, Valencia, 46026

Other trials in Spain

Turkey (Türkiye)6 sites

  • Hacettepe University Medical Faculty

    Ankara, Ankara, 06100

  • Ankara City Hospital

    Ankara, Ankara, 06800

  • Dicle University, Medical Faculty

    Diyarbakır, Diyarbakır, 21280

  • Acibadem Atakent Hospital

    Istanbul, Istanbul, 34303

  • Ege University Medical Faculty

    Izmir, İzmir, 35100

  • Ondokuz Mayis Univ. Med. Fac.

    Samsun, Samsun, 55270

Other trials in Turkey (Türkiye)

Australia5 sites

  • Royal Brisbane & Women's Hospital

    Herston, Queensland, 4029

  • The Alfred Hospital

    Melbourne, Victoria, 3181

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal NorthShore Hospital

    Saint Leonards, New South Wales, 2065

Other trials in Australia

Taiwan5 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, Kaohsiung, 807

  • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare

    New Taipei City, New Taipei City, 23561

  • China Medical University Hospital

    Taichung, 404

  • National Taiwan University Hospital

    Taipei, Taipei

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Belgium4 sites

  • AZ Sint-Jan

    Bruges, 8000

  • Hôpital Erasme

    Brussels, 1070

  • Universitair Ziekenhuis Gent

    Ghent, Gent, 3000

  • UZ Leuven

    Leuven, Belgium, 3000

Other trials in Belgium

Canada4 sites

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • Hamilton Health Sciences - Juravinski Site

    Hamilton, Ontario, L8L 2X2

  • Toronto General Hospital

    Toronto, Ontario, M5G1M1

  • University Health Network

    Toronto, Ontario, M5G1N8

Other trials in Canada

Germany4 sites

  • Charite Universitatsmedizin Berlin

    Berlin, State of Berlin, 12203

  • Universitaetsklinikum Koeln

    Cologne, Koeln, 59037

  • UKE Universitaetsklinikum-Hamburg Eppendorf

    Hamburg-Eppendorf, 30625

  • Universitatsklinikum Leipzig

    Leipzig, Saxony, 4103

Other trials in Germany

Israel4 sites

  • Soroka University Medical Center

    Beersheba, Beer-Sheva, 84001

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, Jerusalem, 9112001

  • Chaim Sheba Medical Center

    Ramat Gan, Ramat Gan, 5265601

  • Tel Aviv Sourasky Medical Center Pt

    Tel Aviv, Tel Aviv, 64239

Other trials in Israel

United Kingdom3 sites

  • University Hospital of Wales

    Cardiff, Wales, CF14 4XW

  • Kings College Hospital

    London, SE5 9RS

  • Imperial College London

    London, W6 8RP

Other trials in United Kingdom

Vietnam3 sites

  • Bach Mai Hospital

    Hanoi, 10000

  • National Lung Hospital

    Hanoi, 10000

  • National Institute of Hematology and Blood Transfusion

    Hanoi, 122000

Other trials in Vietnam

Netherlands2 sites

  • Radboud Nijmegen

    Nijmegen, Nijmegen, 6525GA

  • UMC Utrecht

    Utrecht, Utrecht, 3508 GA

Other trials in Netherlands

New Zealand2 sites

  • Auckland City Hospital

    Auckland, Auckland, 1023

  • Wellington Regional Hospital

    Newtown, Wellington Region, 6021

Other trials in New Zealand

Singapore2 sites

  • National University Hospital

    Singapore, Singapore, 117599

  • Singapore General Hospital- Parent

    Singapore, Singapore, 169608

Other trials in Singapore

South Korea2 sites

  • The Catholic University of Korea

    Bucheon-si, Seoul, 06591

  • Samsung Medical Center

    Irwon-dong, Seoul, 06351

Other trials in South Korea

Thailand2 sites

  • Siriraj Hospital

    Bangkok Noi, Bangkok, 10700

  • Srinagarind Hospital

    Khon Kaen, Changwat Khon Kaen, 40002

Other trials in Thailand

About this study

Official title: Phase III, Adjudicator-blinded, Randomised Study to Evaluate Efficacy and Safety of Treatment With Olorofim Versus Treatment With AmBisome® Followed by Standard of Care in Patients With Invasive Fungal Disease Caused by Aspergillus Species

The purpose of this study is to compare treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or probable lower respiratory tract disease Aspergillus species (invasive aspergillosis, IA).

Read the detailed description

The mortality rate in immunosuppressed patients with IA is high even with effective modern antifungal drug treatment. Intrinsic and acquired resistance to azoles and amphotericin B, the two most effective classes of treatment, have been identified in Aspergillus species and are linked to this increased mortality.

Currently marketed antifungal drugs have limitations including limited dosage forms, DDIs, and significant adverse reactions.

For patients with IA who do not respond to or cannot tolerate a triazole therapy, treatment options are even more limited.

Olorofim is an antifungal candidate with a novel mechanism of action offering activity against resistant organisms, differences in safety profile, along with oral dosing, predictable and reliable pharmacokinetic (PK) profile and limited potential for DDIs.

The present study is designed to compare the efficacy, safety, and tolerability of olorofim with that of AmBisome® followed by guideline-based hierarchy standard of care (SOC) in patients with IA whose infection is either refractory to or unsuitable for azole therapy.

Being tested
Olorofim, AmBisome®
Keywords
Invasive fungal disease (IFD), Aspergillus species, Olorofim, Non-azole antifungal, Azole resistance
Medical subject headings
Invasive Fungal Infections

What participants receive

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

  • OlorofimDrug

    Also called Olorofim (F901318)

    Loading Dose: 5 tablets (150 mg) to be taken twice daily at a 12-hour (± 1 hour) interval on Day 1 Maintenance Dose: 3 tablets (90 mg) to be taken twice daily at 12-hour (± 1 hour) intervals from Day 2 until Day 84 (± 7 days)

  • AmBisome®Drug

    Also called AmBisome® (liposomal amphotericin B)

    Initial course of at least 10 days of AmBisome® administered daily at a dose of 3 mg/kg by IV infusion over a 30- to 60-minute period or according to local guidelines Administration of SOC will follow international, national, or local guidelines and product labelling.

Study groups in NCT05101187
Study groupRoleWhat they receive
OlorofimActive comparatorOlorofim versus AmBisome followed by Standard of Care (SOC)
Receives: Drug: Olorofim
AmBisomeActive comparatorOlorofim versus AmBisome followed by Standard of Care (SOC)
Receives: Drug: AmBisome®

What is being measured

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

  1. All-cause mortality

    To compare all-cause mortality (ACM) at Day 42 following treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in the intent-to-treat (ITT) population of patients with Invasive Fungal Disease (IFD) caused by proven Invasive Aspergillosis (IA) at any site or probable lower respiratory tract disease (LRTD) Aspergillus species (invasive aspergillosis, IA).

    Measured: Treatment Day 42

Secondary outcomes (9)

  1. Adjudicated Assessment of Overall outcome

    To compare the effects of treatment with olorofim versus treatment with AmBisome® followed by SOC on Data Review Committee (DRC)-adjudicated assessment of overall outcome in patients with proven IA or probable LRTD IA at Day 42, Day 84, and End of Treatment.

    Measured: Day 42, Day 84, and End of Treatment (anytime during the study between first administration and Day 84)

  2. Investigator-assessed overall response

    Investigator-assessed overall response (integrating clinical, radiological, and mycological response).

    Measured: Day 14, Day 28, Day 42, Day 84, EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days]), and 4-week Follow-up (FU).

  3. To compare the effects of treatment with olorofim versus treatment with AmBisome® followed by SOC on Galactomannan index.

    The Sponsor's expert advisors suggested that an appropriate rule would be a failure of the GM to decline from baseline. The experts also state that they have seen very significant variation on retesting of both BAL and serum GM samples and believe it is more appropriate to state a fixed reduction of ≥ 1.0 units than any percentage reduction.

    These rules are used for changes in GM that document failure of therapy:

    1. Serum: After 8 or more days of treatment, serum GM has neither (1) fallen by ≥ 1 unit nor (2) to < 0.5 based on measurements taken at least 8 days apart.
    2. BAL: After 8 or more days of treatment, positive GM from BAL in a patient with a previous BAL test that did not meet the definition of positive (too low or entirely negative) without regard for the interval of time between samples.

    Measured: Day 14, Day 28, Day 42, Day 84, EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days]) and 4-week Follow-up (FU)

  4. To collect additional olorofim and the disproportionate metabolite H26C pharmacokinetic (PK) data for inclusion in a Population PK model

    To collect plasma concentration of olorofim and H26C metabolic for for PK analysis (pre-dose and intensive PK). No non-compartmental PK analysis will be performed on the data relating to pre-dose samples and intensive PK samples, apart from data collected from selected regions, which will be reported separately. All relevant olorofim data will be provided to support population PK modelling, which will be reported separately.

    Measured: Day 10, Day 14, Day 21, Day 28, Day 42, Day 56, Day 70, Day 84, and at EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days])

  5. Data Review Committee's Assessment of Patient Mortality

    Study data will be independently assessed by a blinded DRC consisting of independent experts in the diagnosis and management of IA, providing an independent adjudication of each patient's mortality based on the survival status collect at time frame.

    Measured: Day 42 and 84 and EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days])

  6. Diagnosis of a secondary fungal infection

    To compare incidence of a secondary fungal infection when patients treated with olorofim versus treatment with AmBisome followed by SOC.

    Measured: at any time through End Of Treatment

  7. Quality of life as measured by the 5 Level 5 Dimension (EQ-5D-5L) at Baseline

    To assess patient's quality of life measured by the 5-Level 5-Dimension EuroQol Group Health-related Quality of Life Questionnaire (EQ-5D-5L) in both treatment groups

    Measured: Days 14 and EOT (End of Treatment - Maximum Treatment 84 days [± 7 Days])

  8. Survival status

    All-cause mortality will be assessed using survival status at time frame.

    Measured: Day 42, Day 84, and End Of Treatment and at the 4 weeks ± 7 days FU

  9. Safety Assessment

    To monitor incidence of Adverse Events and Serious Adverse Events in both treatment arms (Olorofim or AmBisome followed by Standard of Care).

    Measured: up to the Day 84 and 4-week Follow-up (FU)

Timeline

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

  1. First posted1 Nov 2021
  2. Study start29 Apr 2022
  3. Primary completion18 Nov 2025
  4. Study completion19 Mar 2026

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05101187
Sponsor's protocol ID
F901318/0041
Acronym
OASIS
Status last verified
Oct 2026
First submitted
7 Sep 2021
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Xu H, Liang T, Wang Z, Wei Y, Wan Z, Li R, Zhang L, Liu W. Amino acid substitutions at the G118 hotspot in dihydroorotate dehydrogenase confer olorofim resistance in Aspergillus flavus. Microbiol Spectr. 2026 Aug 4;14(8):e0025126. doi: 10.1128/spectrum.00251-26. Epub 2026 Jul 14.

    PubMed 42446237

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Olorofim and AmBisome® in people with Invasive Aspergillosis, run by F2G Ltd at 143 sites in 21 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 4 inclusion and 10 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 8 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 143 sites in United States, China, Japan, Italy, France and 16 more countries. 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 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 (time frame: Treatment Day 42). 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 NCT05101187, 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 8 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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