About: STudy of Alteplase for Respiratory failure in SARS‐Cov2/COVID‐19: Study Design of the Phase IIa STARS Trial

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About: STudy of Alteplase for Respiratory failure in SARS‐Cov2/COVID‐19: Study Design of the Phase IIa STARS Trial Goto Sponge NotDistinct Permalink

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
title	STudy of Alteplase for Respiratory failure in SARS‐Cov2/COVID‐19: Study Design of the Phase IIa STARS Trial
Creator	Moore, Peter Barrett, Christopher Talmor, Daniel Hajizadeh, Negin Mcintyre, Robert Moore, Ernest Moore, Hunter Mph, M Wang, Janice Yaffe, Michael Sauaia, Angela Jhunjhnuwala, Rashi
source	Medline; PMC
abstract	BACKGROUND: The COVID‐19 pandemic has caused a large surge of acute respiratory distress syndrome (ARDS). Prior phase I trials (non COVID‐19) demonstrated improvement in pulmonary function in ARDS patients using fibrinolytic therapy. A follow‐up trial using the widely available tissue‐plasminogen activator (alteplase) is now needed to assess optimal dosing and safety in this critically ill patient population. OBJECTIVE: To describe the design and rationale of a Phase IIa trial to evaluate the safety and efficacy of alteplase treatment for moderate/severe COVID‐19‐induced ARDS. PATIENTS/METHODS: A rapidly adaptive, pragmatic, open label, randomized, controlled, phase IIa clinical trial will be conducted with three groups: intravenous(IV) alteplase 50mg, IV alteplase 100mg, and control (standard‐of‐care). Inclusion criteria are known/suspected COVID‐19 infection with PaO2/FiO2 ratio<150mmHg for >4 hours despite maximal mechanical ventilation management. Alteplase will be delivered through an initial bolus of 50mg or 100mg followed by heparin infusion for systemic anticoagulation, with alteplase re‐dosing if there is a >20% PaO2/FiO2 improvement not sustained by 24 hours. RESULTS: The primary outcome is improvement in PaO2/FiO2 at 48 hours post‐randomization. Other outcomes include: ventilator‐ and ICU‐free‐days, successful extubation (no reintubation ≤3 days after initial extubation), and mortality. Fifity eligible patients will be enrolled in a rapidly adaptive, modified stepped‐wedge design with four looks at the data. CONCLUSION: Findings will provide timely information on the safety, efficacy and optimal dosing of tPA to treat moderate/severe COVID‐19‐induced ARDS, which can be rapidly adapted to a phase III trial. (NCT04357730; FDA IND 149634)
has issue date	2020-05-21(xsd:dateTime)
bibo:doi	10.1002/rth2.12395
bibo:pmid	32838109
has license	cc-by-nc-nd
sha1sum (hex)	13f0145ef769bf60277ec0c1fd4868cea97ba8e6
schema:url	https://doi.org/10.1002/rth2.12395
resource representing a document's title	STudy of Alteplase for Respiratory failure in SARS‐Cov2/COVID‐19: Study Design of the Phase IIa STARS Trial
has PubMed Central identifier	PMC7280574
has PubMed identifier	32838109
schema:publication	Res Pract Thromb Haemost
resource representing a document's body	covid:13f0145ef769bf60277ec0c1fd4868cea97ba8e6#body_text
is schema:about of	named entity 'pragmatic' named entity 'risk' named entity 'lungs' named entity 'RISK OF' named entity 'DOSING' named entity 'acute respiratory distress syndrome (ARDS)' named entity 'tPA' named entity 'Two' named entity 'tissue plasminogen activator' named entity 'phase IIa' named entity 'Fibrinolytics' named entity 'tPA' named entity 'Study Design' named entity 'tissue plasminogen activator' named entity 'fibrin' named entity 'percent saturation' named entity 'MRI' named entity 'coagulation' named entity 'tPA' named entity 'DSMB' named entity 'alteplase' named entity 'megakaryocytes' named entity 'venous thromboembolism' named entity 'multiple comparisons' named entity 'microthrombi' named entity 'missing at random' named entity 'tPA' named entity 'endothelium' named entity 'coagulation' named entity 'Phase IIa' named entity 'sea level' named entity 'alveolar' named entity 'nitric oxide' named entity 'REDCap' named entity 'fibrinolytic' named entity '2, 7' named entity 'sample size' named entity 'blood gas' named entity 't-tests' named entity 'Tissue factor' named entity 'alveoli' named entity 'fibrinolysis' named entity 'fibrinolysis' named entity 'Multiple imputation' named entity 'hypercoagulability' named entity 'cytokine' named entity 'randomized controlled trials' named entity 'China' named entity 'PaO2' named entity 'hypoxemia' named entity 'vasculature' named entity 'stepped-wedge' named entity 'oxygen' named entity 'stroke' named entity 'critically ill patients' named entity 'hepatitis B vaccine' named entity 'interim analyses' named entity 'respiratory failure' named entity 'neurological exam' named entity 'fibrinogen' named entity 'sepsis' named entity 'intensive care' named entity 'paralytic agents' named entity 'TFPI' named entity 'PaO2/FiO2' named entity 'Endotoxin' named entity 'Fibrinolysis' named entity 'Autopsies' named entity 'adverse events' named entity 'TNF-alpha'

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