{"doi":"10.1002/rth2.12395","title":"Study of alteplase for respiratory failure in severe acute respiratory syndrome coronavirus 2/COVID‐19: Study design of the phase IIa STARS trial","abstract":"Background: The coronavirus disease 2019 (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 patients ARDS using fibrinolytic therapy. A follow-up trial using the widely available tissue-type plasminogen activator (t-PA) 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: improvement not sustained by 24 hours. Results: at 48 hours after randomization. Other outcomes include ventilator- and intensive care unit-free days, successful extubation (no reintubation ≤3 days after initial extubation), and mortality. Fifty eligible patients will be enrolled in a rapidly adaptive, modified stepped-wedge design with 4 looks at the data. Conclusion: Findings will provide timely information on the safety, efficacy, and optimal dosing of t-PA to treat moderate/severe COVID-19-induced ARDS, which can be rapidly adapted to a phase III trial (NCT04357730; FDA IND 149634).","journal":"Research and Practice in Thrombosis and Haemostasis","year":2020,"id":103965,"datarank":1.1065207824947725,"base_score":3.2188758248682006,"endowment":3.2188758248682006,"self_citation_contribution":0.48283137373023016,"citation_network_contribution":0.6236894087645423,"self_endowment_contribution":0.48283137373023016,"citer_contribution":0.6236894087645423,"corpus_percentile":null,"corpus_rank":null,"citation_count":24,"citer_count":18,"citers_with_citation_signal":15,"citers_with_endowment":15,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9625,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT04357730"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":292347,"name":"Christopher D. Barrett","orcid":"0000-0001-9720-8155","position":1,"is_corresponding":false},{"id":228447,"name":"Ernest E. Moore","orcid":"0000-0002-0419-4848","position":2,"is_corresponding":false},{"id":505969,"name":"Rashi Jhunjhunwala","orcid":"0000-0002-0970-8369","position":3,"is_corresponding":false},{"id":228453,"name":"Robert C. McIntyre","orcid":"0000-0003-3468-5610","position":4,"is_corresponding":false},{"id":228452,"name":"Peter K. Moore","orcid":"0000-0001-6446-067X","position":5,"is_corresponding":false},{"id":505970,"name":"Janice Wang","orcid":"0000-0002-3752-9851","position":6,"is_corresponding":false},{"id":94682,"name":"Negin Hajizadeh","orcid":"0000-0002-6404-1018","position":7,"is_corresponding":false},{"id":292348,"name":"Daniel Talmor","orcid":"0000-0002-7239-8068","position":8,"is_corresponding":false},{"id":505971,"name":"Angela Sauaia","orcid":"0000-0002-8493-389X","position":9,"is_corresponding":false},{"id":201960,"name":"Michael B Yaffe","orcid":"0000-0002-9547-3251","position":10,"is_corresponding":false},{"id":228448,"name":"Hunter B. Moore","orcid":"0000-0002-5939-3828","position":0,"is_corresponding":true}],"reference_count":94,"raw_metadata":null,"created_at":"2026-07-18T22:43:22.755723Z","pmid":"32838109","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}