Idiopathic Pulmonary FibrosisPhase 3MERCURION-IPFNCT07299695
Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis
A Phase 3 study testing Intravenous immunoglobulin (IVIG) and Usual treatment in people with Idiopathic Pulmonary Fibrosis and Acute Exacerbation of Idiopathic Pulmonary Fibrosis, run by Argyrios Tzouvelekis at 1 site in Greece.
Trial summary
Acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF) are sudden and severe worsening episodes that can be life-threatening. Currently, no treatment has been proven to clearly improve outcomes during these events. Inflammation and immune system imbalance are thought to play an important role in causing AE-IPF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Acute Exacerbation of Idiopathic Pulmonary Fibrosis
- What is being tested?
- Intravenous immunoglobulin (IVIG) and Usual treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteGreece
- Study dates
- 25 Jan 2026to Dec 2028
- Phase
- Phase 3
- 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
- Patients ≥ 18 years of age
- Patients with IPF diagnosis that fulfils ATS/ERS Consensus Criteria.
- Patients hospitalised with a definite or suspected AE-IPF diagnosis, as defined by the international working group criteria and as ascertained by the responsible Primary Investigator.
- The criteria of IPF-AE are as follows:
- Previous or concurrent diagnosis of IPF
- Acute worsening or development of dyspnoea typically < 1 month duration
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- Computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia pattern
- Deterioration not fully explained by cardiac failure or fluid overload Patients who fail to meet all 4 criteria due to missing computed tomography should be considered as having "suspected Acute Exacerbation".
- If the diagnosis of IPF is not previously established, this criterion can be met by the presence of radiologic and/or histopathologic changes consistent with usual interstitial pneumonia pattern on the current evaluation.
- If no previous computed tomography is available, the qualifier "new" can be dropped from the third AE-IPF criterion.
- Patient able to understand and sign a written informed consent form. In case of incapacity of the patient, the written informed consent form will be signed by the patients' legally authorized representative.
Who cannot join
- Patients with acute worsening due to uncontrolled heart failure or pulmonary embolism.
- Patients with known hypersensitivity to corticosteroids, IVIG or any component of the study treatment.
- Patients with known IgA deficiency (IgA level <7 mg/dL)- to preclude IVIG reactions.
- Patients without a definite diagnosis of IPF or AE-IPF based on clinical, radiological, laboratory evaluation, and multidisciplinary discussion.
- Patients with active malignancy or currently receiving cancer treatment, except for basal cell or squamous cell skin cancer or low-risk prostate cancer (T1 or T2a stage with PSA <10 ng/dL). These criteria are aligned with current guidelines.
- Patients that have received treatment for >14 days within the preceding month with >20mg daily prednisone (or equivalent) or any treatment during the last month with immunosuppressants (e.g., cyclophosphamide, mycophenolate etc.) according to already published therapeutic protocols or > 1 mg/kg/d from more than 7 days in the last 15 days.
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- Patients participating to another interventional clinical trial.
- Patients with documented pregnancy or lactation.
- Patients under tutorship or curatorship.
- Patients deprived of liberty or under court protection.
- Patients who refuse to participate or decline to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Department of Respiratory Medicine, University Hospital of Patras
Pátrai, 26504
Argyrios Tzouvelekis, MD, MSc, PhD, Professor of Respiratory Medicine, +302613603524, atzouvelekis@upatras.gr
About this study
Official title: A Prospective, Multicenter, Randomized, Open-Label Clinical Trial Evaluating the Efficacy of Intravenous Immunoglobulin in Patients Hospitalized for Acute Exacerbations of Idiopathic Pulmonary Fibrosis.
Acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF) are sudden and severe worsening episodes that can be life-threatening. Currently, no treatment has been proven to clearly improve outcomes during these events. Inflammation and immune system imbalance are thought to play an important role in causing AE-IPF. Early clinical experience suggests that intravenous immunoglobulin (IVIG) can be beneficial for patients suffering from AE-IPF. This clinical trial aims to determine whether adding IVIG to usual treatment can improve outcomes for patients hospitalized with AE-IPF.
Read the detailed description
Acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF) are sudden, life-threatening deteriorations associated with high mortality. Despite their severe impact on a substantial subset of patients with IPF, no treatment has yet demonstrated clear, reproducible benefit, and standardized therapeutic strategies remain lacking.
This prospective, multicenter, randomized study aims to address this critical unmet need by evaluating the efficacy of IVIG in patients with AE-IPF.
Aberrant inflammation and dysregulated immune responses are believed to play a key role in the pathogenesis of AE-IPF. Patients with IPF often display impaired cellular and humoral immunity, further supporting the investigation of immunomodulatory therapies. Intravenous immunoglobulin (IVIG), which has established anti-inflammatory and immunomodulatory effects, is used in other rapidly progressive interstitial lung diseases and in various immune-mediated conditions. Preliminary retrospective data from investigators' center suggest that IVIG may improve gas exchange and survival in patients hospitalized with acute exacerbations of fibrotic interstitial lung disease, including IPF.
Investigators hypothesize that the addition of IVIG to usual treatment may improve clinically relevant outcomes during AE-IPF. In this study, IVIG will be administered as an adjunct to usual care. Usual care will include pulse corticosteroids, broad-spectrum antibiotics, prophylactic anticoagulation, and oxygen therapy. Although the effectiveness of corticosteroids in AE-IPF remains uncertain and is supported only by low-quality evidence, their use is endorsed by current treatment guidelines and remains widespread in clinical practice. In addition, corticosteroids are being evaluated in ongoing trials (e.g., EXAFIP2, NCT05674994). Considering the complex, multi-pathway biology of AE-IPF and the documented synergistic effects of IVIG and corticosteroids in other immune-mediated conditions (such as Kawasaki disease, idiopathic thrombocytopenic purpura, and toxic epidermal necrolysis/Stevens-Johnson syndrome), corticosteroids will be administered to both study arms to avoid withholding a potentially beneficial therapy.
The primary objective of this clinical trial is to evaluate whether IVIG, when added to usual care, improves outcomes compared to usual care alone in patients hospitalized with AE-IPF. The primary endpoint is a composite of all-cause in-hospital mortality or the need for endotracheal intubation. This composite measure was selected because AE-IPF is a rapidly progressive and life-threatening event, and these outcomes represent the most objective, clinically meaningful indicators of deterioration. The use of this endpoint enables a comprehensive assessment of treatment efficacy by capturing both fatal and near-fatal clinical events.
Investigators anticipate that the findings of this study will generate important evidence regarding the potential role of IVIG in the management of AE-IPF and may contribute to future treatment recommendations for this highly lethal condition.
- Being tested
- Intravenous immunoglobulin (IVIG), Usual treatment
- Keywords
- Acute Exacerbations of Idiopathic Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, Intravenous Immunoglobulin, Acute Exacerbation of Idiopathic Pulmonary Fibrosis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous immunoglobulin (IVIG)Drug
Total dose of 1 g/kg, divided over three consecutive days. The infusion will start at a rate of 0.5 mg/kg/hour for the first 15 minutes and, if no adverse reaction occurs, the rate will then be gradually increased step-wise as tolerated. Premedication with acetaminophen and levocetirizine.
Usual treatment will be co-administered, as described.
Usual treatmentDrug
- Corticosteroids: A pulse regimen of IV methylprednisolone at 250 mg daily (days 1 to 3), with no additional corticosteroids thereafter.
- Antibiotics: Empirical broad-spectrum antibiotics starting from the first 24 hours of hospitalization - respiratory quinolone and/or an antipseudomonal penicillin. Duration or escalation of antibiotics may be adjusted based on available antibiograms or treating physician's clinical judgment.
- Anticoagulation: Prophylactic-dose anticoagulation - low molecular weight heparin or fondaparinux - throughout hospitalization. Patients with an established indication for therapeutic anticoagulation will be maintained on their therapeutic regimen.
- Antifibrotic therapy:
Antifibrotics (nintedanib, pirfenidone, or nerandomilast) will be continued during hospitalization if already prescribed and not contraindicated. No new antifibrotic treatment will be initiated during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Usual treatment | Active comparator | Usual treatment will consist of broad-spectrum antibiotics, pulse methylprednisolone, prophylactic anticoagulation, and oxygen therapy with high-flow nasal cannula and will be provided to all participants, in both treatment arms. Receives: Drug: Usual treatment |
| Intravenous immunoglobulin plus Usual treatment | Experimental | Intravenous immunoglobulin will be administered along with usual treatment, as described. Receives: Drug: Intravenous immunoglobulin (IVIG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause in-hospital mortality or intubation
This outcome corresponds to the all-cause mortality or intubation rate throughout hospitalisation.
Measured: From date of randomization until the outcome mesure - the date of death from any cause or the date of endotracheal intubation, whichever comes first - assessed up to 4 weeks during hospitalisation.
Secondary outcomes (6)
All-cause 30-day mortality
This outcome corresponds to all-cause mortality rate at Day 30
Measured: 30 days from hospital admission
All-cause 90-day mortality
This outcome corresponds to all-cause mortality rate at Day 90
Measured: 90 days from hospital admission
Hospital readmissions
This outcome corresponds to all-cause hospital readmission rates by Day 180
Measured: 180 days from hospital admission
New acute exacerbation IPF
This outcome corresponds to occurence of new acute exacerbation of IPF by Day 180
Measured: 180 days from hospital admission
Change in PaO₂/FiO₂ Ratio
This outcome corresponds to the change in the PaO₂/FiO₂ ratio from hospital admission to discharge and will be assessed only among survivors
Measured: PaO₂/FiO₂ ratio will be assessed at the day of randomisation prior to therapeutic interventions (except oxygen therapy) and then at the day of hospital discharge - up to 4 weeks post randomisation.
Adverse events
This outcomes corresponds to the presence of adverse events attributable to the trial intervention
Measured: Throughout study completion - an average of 1 year (from randomisation until day 365 of follow up, if feasible)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start25 Jan 2026
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
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 Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- 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
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Argyrios Tzouvelekis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Argyrios Tzouvelekis, University General Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299695
- Sponsor's protocol ID
- AT011225
- Acronym
- MERCURION-IPF
- Status last verified
- Mar 2026
- First submitted
- 26 Nov 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sotiropoulou V, Sampsonas F, Vasarmidi E, Antoniou K, Gogali A, Kostikas K, Drakopanagiotakis F, Steiropoulos P, Margaritopoulos G, Porpodis K, Daniil Z, Tomos I, Papanikolaou I, Tzilas V, Loukides S, Tzouvelekis A. Design of the MERCURION-IPF trial - intravenous immunoglobulin for the treatment of acute exacerbations of idiopathic pulmonary fibrosis. Front Immunol. 2026 May 5;17:1777564. doi: 10.3389/fimmu.2026.1777564. eCollection 2026.
PubMed 42164489
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Open-Label Clinical Trial Evaluating the Efficacy of Intravenous Immunoglobulin in Patients Hospitalized for Acute Exacerbations of Idiopathic Pulmonary Fibrosis.
- ClinicalTrials.gov ID
- NCT07299695
- Acronym / sponsor ID
- MERCURION-IPF / AT011225
- Keywords
- Acute Exacerbations of Idiopathic Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, Intravenous Immunoglobulin, Acute Exacerbation of Idiopathic Pulmonary Fibrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Argyrios TzouvelekisUniversity, hospital or other
- Study start
- 25 Jan 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Dec 2025 (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.
Acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF) are sudden and severe worsening episodes that can be life-threatening. Currently, no treatment has been proven to clearly improve outcomes during these events. Inflammation and immune system imbalance are thought to play an important role in causing AE-IPF. Early clinical experience suggests that intravenous immunoglobulin (IVIG) can be beneficial for patients suffering from AE-IPF. This clinical trial aims to determine whether adding IVIG to usual treatment can improve outcomes for patients hospitalized with AE-IPF.
Detailed description
Acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF) are sudden, life-threatening deteriorations associated with high mortality. Despite their severe impact on a substantial subset of patients with IPF, no treatment has yet demonstrated clear, reproducible benefit, and standardized therapeutic strategies remain lacking.
This prospective, multicenter, randomized study aims to address this critical unmet need by evaluating the efficacy of IVIG in patients with AE-IPF.
Aberrant inflammation and dysregulated immune responses are believed to play a key role in the pathogenesis of AE-IPF. Patients with IPF often display impaired cellular and humoral immunity, further supporting the investigation of immunomodulatory therapies. Intravenous immunoglobulin (IVIG), which has established anti-inflammatory and immunomodulatory effects, is used in other rapidly progressive interstitial lung diseases and in various immune-mediated conditions. Preliminary retrospective data from investigators' center suggest that IVIG may improve gas exchange and survival in patients hospitalized with acute exacerbations of fibrotic interstitial lung disease, including IPF.
Investigators hypothesize that the addition of IVIG to usual treatment may improve clinically relevant outcomes during AE-IPF. In this study, IVIG will be administered as an adjunct to usual care. Usual care will include pulse corticosteroids, broad-spectrum antibiotics, prophylactic anticoagulation, and oxygen therapy. Although the effectiveness of corticosteroids in AE-IPF remains uncertain and is supported only by low-quality evidence, their use is endorsed by current treatment guidelines and remains widespread in clinical practice. In addition, corticosteroids are being evaluated in ongoing trials (e.g., EXAFIP2, NCT05674994). Considering the complex, multi-pathway biology of AE-IPF and the documented synergistic effects of IVIG and corticosteroids in other immune-mediated conditions (such as Kawasaki disease, idiopathic thrombocytopenic purpura, and toxic epidermal necrolysis/Stevens-Johnson syndrome), corticosteroids will be administered to both study arms to avoid withholding a potentially beneficial therapy.
The primary objective of this clinical trial is to evaluate whether IVIG, when added to usual care, improves outcomes compared to usual care alone in patients hospitalized with AE-IPF. The primary endpoint is a composite of all-cause in-hospital mortality or the need for endotracheal intubation. This composite measure was selected because AE-IPF is a rapidly progressive and life-threatening event, and these outcomes represent the most objective, clinically meaningful indicators of deterioration. The use of this endpoint enables a comprehensive assessment of treatment efficacy by capturing both fatal and near-fatal clinical events.
Investigators anticipate that the findings of this study will generate important evidence regarding the potential role of IVIG in the management of AE-IPF and may contribute to future treatment recommendations for this highly lethal condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual treatment | Active comparator | Drug: Usual treatmentUsual treatment will consist of broad-spectrum antibiotics, pulse methylprednisolone, prophylactic anticoagulation, and oxygen therapy with high-flow nasal cannula and will be provided to all participants, in both treatment arms. |
| Intravenous immunoglobulin plus Usual treatment | Experimental | Drug: Intravenous immunoglobulin (IVIG)Intravenous immunoglobulin will be administered along with usual treatment, as described. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients ≥ 18 years of age
- Patients with IPF diagnosis that fulfils ATS/ERS Consensus Criteria.
- Patients hospitalised with a definite or suspected AE-IPF diagnosis, as defined by the international working group criteria and as ascertained by the responsible Primary Investigator.
- Patient able to understand and sign a written informed consent form. In case of incapacity of the patient, the written informed consent form will be signed by the patients' legally authorized representative.
Key exclusion criteria (11 listed)
- Patients with acute worsening due to uncontrolled heart failure or pulmonary embolism.
- Patients with known hypersensitivity to corticosteroids, IVIG or any component of the study treatment.
- Patients with known IgA deficiency (IgA level <7 mg/dL)- to preclude IVIG reactions.
- Patients without a definite diagnosis of IPF or AE-IPF based on clinical, radiological, laboratory evaluation, and multidisciplinary discussion.
- Patients with active malignancy or currently receiving cancer treatment, except for basal cell or squamous cell skin cancer or low-risk prostate cancer (T1 or T2a stage with PSA <10 ng/dL). These criteria are aligned with current guidelines.
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 |
|---|---|---|
| Intravenous immunoglobulin (IVIG)Total dose of 1 g/kg, divided over three consecutive days. The infusion will start at a rate of 0.5 mg/kg/hour for the first 15 minutes and, if no adverse reaction occurs, the rate will then be gradually increased step-wise as tolerated. Premedication with acetaminophen and levocetirizine. Usual treatment will be co-administered, as described. | Drug | Intravenous immunoglobulin plus Usual treatment |
| Usual treatment1. Corticosteroids: A pulse regimen of IV methylprednisolone at 250 mg daily (days 1 to 3), with no additional corticosteroids thereafter. 2. Antibiotics: Empirical broad-spectrum antibiotics starting from the first 24 hours of hospitalization - respiratory quinolone and/or an antipseudomonal penicillin. Duration or escalation of antibiotics may be adjusted based on available antibiograms or treating physician's clinical judgment. 3. Anticoagulation: Prophylactic-dose anticoagulation - low molecular weight heparin or fondaparinux - throughout hospitalization. Patients with an established indication for therapeutic anticoagulation will be maintained on their therapeutic regimen. 4. Antifibrotic therapy: Antifibrotics (nintedanib, pirfenidone, or nerandomilast) will be continued during hospitalization if already prescribed and not contraindicated. No new antifibrotic treatment will be initiated during the study period. | Drug | Usual treatment |
Primary outcome
All-cause in-hospital mortality or intubation
Time frame: From date of randomization until the outcome mesure - the date of death from any cause or the date of endotracheal intubation, whichever comes first - assessed up to 4 weeks during hospitalisation.
This outcome corresponds to the all-cause mortality or intubation rate throughout hospitalisation.
6 secondary outcomes
All-cause 30-day mortality
Time frame: 30 days from hospital admission
All-cause 90-day mortality
Time frame: 90 days from hospital admission
Hospital readmissions
Time frame: 180 days from hospital admission
New acute exacerbation IPF
Time frame: 180 days from hospital admission
Change in PaO₂/FiO₂ Ratio
Time frame: PaO₂/FiO₂ ratio will be assessed at the day of randomisation prior to therapeutic interventions (except oxygen therapy) and then at the day of hospital discharge - up to 4 weeks post randomisation.
Adverse events
Time frame: Throughout study completion - an average of 1 year (from randomisation until day 365 of follow up, if feasible)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Derived from this study: PubMed 42164489Sotiropoulou V, Sampsonas F, Vasarmidi E, Antoniou K, Gogali A, Kostikas K, Drakopanagiotakis F, Steiropoulos P, Margaritopoulos G, Porpodis K, Daniil Z, Tomos I, Papanikolaou I, Tzilas V, Loukides S, Tzouvelekis A. Design of the MERCURION-IPF trial - intravenous immunoglobulin for the treatment of acute exacerbations of idiopathic pulmonary fibrosis. Front Immunol. 2026 May 5;17:1777564. doi: 10.3389/fimmu.2026.1777564. eCollection 2026.
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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.
Department of Respiratory Medicine, University Hospital of Patras
Pátrai, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous immunoglobulin (IVIG) and Usual treatment in people with Idiopathic Pulmonary Fibrosis and Acute Exacerbation of Idiopathic Pulmonary Fibrosis, run by Argyrios Tzouvelekis at 1 site in Greece.
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 11 inclusion and 11 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 16 Mar 2026. 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 Greece. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause in-hospital mortality or intubation (time frame: From date of randomization until the outcome mesure - the date of death from any cause or the date of endotracheal intubation, whichever comes first - assessed up to 4 weeks during hospitalisation.). 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 NCT07299695, 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 Mar 2026.