Acute Respiratory Distress SyndromePhase 2ESKANCT05914454
Efficacy and Safety of Anakinra in Acute Respiratory Distress Syndrome
A Phase 2 study testing Anakinra 100Mg/0.67Ml Inj Syringe in people with Acute Respiratory Distress Syndrome, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.
Trial summary
Acute Respiratory Distress Syndrome (ARDS) is a life-threatening condition characterized by acute respiratory failure with hypoxemia, noncardiogenic or non-fluid overload pulmonary edema, bilateral diffuse opacities on chest radiograph in the presence of a predisposing factor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Anakinra 100Mg/0.67Ml Inj Syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 19 May 2023to 19 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to intensive care unit diagnosed within 48 hours of moderate-severe ARDS (PaO2/FiO2 < 200, PEEP ≥ 5 cmH2O) and requiring intubation and mechanical ventilation;
- Berlin clinical criteria for definition of ARDS: onset within 1 week of initial lesion or new or worsening respiratory symptoms, bilateral opacities not fully explained by effusions, lobar or lung collapse or nodules, respiratory failure not fully explained by heart failure or fluid overload
- ARDS-like clinical-laboratory profile, defined by at least one of the following criteria:
- high plasma levels of inflammatory biomarkers (e.g. IL-6 > 80 pg/ml, CRP > 250 mg/l)
- dependence on vasopressors (of any type and at any dosage for at least one hour of treatment)
- reduction of bicarbonatemia (< 18 mMol/L) or hyperlactacidemia (> 4 mMol/L)
- Informed consent for participation in the study
- Negative swab for COVID-19.
Who cannot join
- Pregnant or lactating patients;
- Hypersensitivity to the active substance or to any of the excipients or to proteins derived from Escherichia Coli;
- Concomitant treatment with anti-TNF-alpha or other biotechnological agent;
- Neutropenia (neutrophils < 1.5 x 109/L);
- Pre-existing malignancies;
- Moderate to severe renal insufficiency, creatinine clearance < 60 ml/minute.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Sanitaria Universitaria
Udine, 33100
Tiziana Quartuccio, MD, PhD, +39 0432559501, tiziana.bove@asufc.sanita.fvg.it
Luca Quartuccio, MD, PhD
About this study
Acute Respiratory Distress Syndrome (ARDS) is a life-threatening condition characterized by acute respiratory failure with hypoxemia, noncardiogenic or non-fluid overload pulmonary edema, bilateral diffuse opacities on chest radiograph in the presence of a predisposing factor.
In ARDS there is activation of the inflammatory cascade which is very intense and persistent in the severe types. It was highlighted that the inflammatory cytokines in patients with ARDS or sepsis is similar to that observed in COVID-19 positive patients.
Read more
Emerging therapies include immunomodulation and the administration of mesenchymal stem cells for the modulation of lung repair through the release of cytokines and growth factors that modulate the local inflammatory response.
Regardless of the cause of ARDS, the severity of the inflammatory state and fibroproliferative evolution have been shown to be independent predictors of survival and ventilator dependence. Patients suffering from severe forms of ARDS in fact require prolonged mechanical ventilation, which exposes them to ventilator-associated pneumonia (VAP) and the onset of multiorgan insufficiency. The hyperinflammatory state underlying ARDS predisposes to pulmonary fibroproliferation, which in turn increases susceptibility to ventilator dependence and increases the risk of MOF and death. For this reason, the rationale in the use of anakinra is to limit the inflammatory process of ARDS as early as possible, avoiding the progression of lung damage.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Anakinra 100Mg/0.67Ml Inj Syringe
- Keywords
- IL-1, anakinra, acute respiratory distress syndrome, lung
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anakinra 100Mg/0.67Ml Inj SyringeDrug
anakinra 100 mg per day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| anakinra | Experimental | anakinra 100 mg/day for 14 consecutive days Receives: Drug: Anakinra 100Mg/0.67Ml Inj Syringe |
| standard of care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of ventilation-free days
The calculation will take place from the day of extubation to the 28th day of hospitalization. Patients who die before ventilator weaning will be considered as having 0 days off ventilation. The calculation of the days free from ventilation will be calculated as follows: 28 - number of days of ventilation.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start19 May 2023
- Primary completion19 Jun 2025 (estimated)
- Study completion19 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di Udine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Udine
- Responsible party
- Sponsor
- Investigators
- Tiziana Bove, MD, PhD, Principal investigator, Azienda Sanitaria Universitaria Friuli Centrale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914454
- Sponsor's protocol ID
- 4381
- Acronym
- ESKA
- Status last verified
- Jun 2023
- First submitted
- 13 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Anakinra in Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT05914454
- Acronym / sponsor ID
- ESKA / 4381
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- IL-1, anakinra, acute respiratory distress syndrome, lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di UdineUniversity, hospital or other
- Collaborators
- University of Udine
- Study start
- 19 May 2023 (actual)
- Primary completion
- 19 Jun 2025 (estimated)
- Study completion
- 19 Sep 2025 (estimated)
- First posted
- 22 Jun 2023 (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 Respiratory Distress Syndrome (ARDS) is a life-threatening condition characterized by acute respiratory failure with hypoxemia, noncardiogenic or non-fluid overload pulmonary edema, bilateral diffuse opacities on chest radiograph in the presence of a predisposing factor.
In ARDS there is activation of the inflammatory cascade which is very intense and persistent in the severe types. It was highlighted that the inflammatory cytokines in patients with ARDS or sepsis is similar to that observed in COVID-19 positive patients.
Emerging therapies include immunomodulation and the administration of mesenchymal stem cells for the modulation of lung repair through the release of cytokines and growth factors that modulate the local inflammatory response.
Regardless of the cause of ARDS, the severity of the inflammatory state and fibroproliferative evolution have been shown to be independent predictors of survival and ventilator dependence. Patients suffering from severe forms of ARDS in fact require prolonged mechanical ventilation, which exposes them to ventilator-associated pneumonia (VAP) and the onset of multiorgan insufficiency. The hyperinflammatory state underlying ARDS predisposes to pulmonary fibroproliferation, which in turn increases susceptibility to ventilator dependence and increases the risk of MOF and death. For this reason, the rationale in the use of anakinra is to limit the inflammatory process of ARDS as early as possible, avoiding the progression of lung damage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anakinra | Experimental | Drug: Anakinra 100Mg/0.67Ml Inj Syringeanakinra 100 mg/day for 14 consecutive days |
| standard of care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients admitted to intensive care unit diagnosed within 48 hours of moderate-severe ARDS (PaO2/FiO2 < 200, PEEP ≥ 5 cmH2O) and requiring intubation and mechanical ventilation;
- Berlin clinical criteria for definition of ARDS: onset within 1 week of initial lesion or new or worsening respiratory symptoms, bilateral opacities not fully explained by effusions, lobar or lung collapse or nodules, respiratory failure not fully explained by heart failure or fluid overload
- ARDS-like clinical-laboratory profile, defined by at least one of the following criteria:
- Informed consent for participation in the study
- Negative swab for COVID-19.
Key exclusion criteria (6 listed)
- Pregnant or lactating patients;
- Hypersensitivity to the active substance or to any of the excipients or to proteins derived from Escherichia Coli;
- Concomitant treatment with anti-TNF-alpha or other biotechnological agent;
- Neutropenia (neutrophils < 1.5 x 109/L);
- Pre-existing malignancies;
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 |
|---|---|---|
| Anakinra 100Mg/0.67Ml Inj Syringeanakinra 100 mg per day for 14 days | Drug | anakinra |
Primary outcome
Assessment of ventilation-free days
Time frame: 28 days
The calculation will take place from the day of extubation to the 28th day of hospitalization. Patients who die before ventilator weaning will be considered as having 0 days off ventilation. The calculation of the days free from ventilation will be calculated as follows: 28 - number of days of ventilation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiziana Bove, MD, PhD principal investigator
Azienda Sanitaria Universitaria Friuli Centrale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anakinra 100Mg/0.67Ml Inj Syringe in people with Acute Respiratory Distress Syndrome, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.
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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Jun 2023. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tiziana Bove, MD, PhD (+39 0432559501, tiziana.bove@asufc.sanita.fvg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of ventilation-free days (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2023.