Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT04640194
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years (or above legal age, e.g. UK ≥16 years)
* ARDS with PaO2\*/FiO2 ratio \>100 and ≤300, either on non-invasive ventilator support, OR on mechanical ventilation (\<48 hours since intubation),
* with bilateral opacities in chest X-ray or CT scan (not fully explained by effusions, lobar/lung collapse, or nodules)
* with respiratory failure (not fully explained by cardiac failure/fluid overload) (\*or estimation of PaO2/FiO2 from pulse oximetry (SpO2/FiO2))
* SARS-CoV-2 positive (laboratory-confirmed reverse transcription polymerase chain reaction (RT PCR) test)
* Fibrinogen level ≥ lower limit of normal (according to local laboratory)
* D-Dimer ≥ upper limit of normal (ULN) according to local laboratory
* Signed and dated written informed consent in accordance with ICH Good Clinical Practice (GCP) and local legislation prior to admission to the Trial
Exclusion Criteria:
* Massive confirmed pulmonary embolism (PE) with haemodynamic instability at trial entry, or any (suspected or confirmed) PE that is expected to require therapeutic dosages of anticoagulants during the treatment period
* Indication for therapeutic dosages of anticoagulants at trial entry
* Patients on mechanical ventilation for longer than 48 hours
* Chronic pulmonary disease i.e. with known forced expiratory volume in 1 second (FEV1) \<50%, requiring home oxygen, or oral steroid therapy or hospitalisation for exacerbation within 12 months, or significant chronic pulmonary disease in the Investigator's opinion, or primary pulmonary arterial hypertension
* Has a Do-Not-Intubate (DNI) or Do-Not-Resuscitate (DNR) order
* In the opinion of the investigator not expected to survive for \> 48 hours after admission
* Planned interventions during the first 5 days after randomisation, such as surgery, insertion of central catheter or arterial line, drains, etc.
* Patients with known hypersensitivity to the active substance alteplase, gentamicin (a trace residue from the manufacturing process) or to any of the excipients
* Significant bleeding disorder at present or within the past 3 months, known haemorrhagic diathesis
* Patients receiving effective oral anticoagulant treatment, e.g. vitamin K antagonists with International normalised ratio (INR) \>1.3, or any direct oral anticoagulant within the past 48 hours Further exclusion criteria apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04640194
Study Brief:
Protocol Section:
NCT04640194