BridgeMD
Efficacy and safety of anakinra in non-COVID-19 related ARDS. ESKA study.
EU CTIS ID: 2024-518125-15-00
What this study is testing
The main aim of this study is to evaluate ventilation-free days.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age ≥ 18 years; 2. Any male and female; 3. Patients admitted to the ICU with a diagnosis within 48 hours of moderate-severe ARDS (PaO2/FiO2 < 200, PEEP ≥ 5 cmH2O) and needing intubation and mechanical ventilation; 4. Berlin clinical criteria for definition of ARDS: onset within 1 week of initial injury or of new or worsening respiratory symptoms, bilateral opacities not fully explained by effusion, lobar or pulmonary collapse or nodules, respiratory failure not fully explained by heart failure or fluid overload 5. ARDS-like clinical-laboratory profile, defined by at least one of the following criteria: a. high plasma levels of inflammatory biomarkers (e.g., IL-6 > 80 pg/ml, PCR > 250 mg/l) b. dependence on vasopressors (of any type and at any dosage for at least one hour of treatment) c. decreased bicarbonatemia (< 18 mMol/L) or hyperlactacidemia (> 4 mMol/L) 6. Informed consent for participation in the study; 7. Negative swab for COVID-19.
You likely can't join if
- 1. Age < 18 years; 2. Pregnant or lactating patients; 3. Hypersensitivitỳ to the active ingredient or any of the excipients or to proteins derived from Escherichia coli; 4. Concomitant treatment with anti TNF-alpha; 5. Neutropenia (neutrophils <1.5 x 109/L); 6. Pre-existing malignancies; 7. Moderate-severe renal failure, creatinine CL <60 mL/minute.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.