Evidence map›Paper›PMID 32838109›Full record

ArticleResearch and practice in thrombosis and haemostasis2020

Study of alteplase for respiratory failure in severe acute respiratory syndrome coronavirus 2/COVID-19: Study design of the phase IIa STARS trial.

Hunter B Moore, Christopher D Barrett, Ernest E Moore, Rashi Jhunjhunwala, Robert C McIntyre, Peter K Moore, Janice Wang, Negin Hajizadeh, Daniel S Talmor, Angela Sauaia and 1 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Research and practice in thrombosis and haemostasis, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04357730 (Fibrinolytic Therapy to Treat ARDS in the Setting of COVID-19 Infection), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
0.6field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04357730 phase2completednot on this map

Fibrinolytic Therapy to Treat ARDS in the Setting of COVID-19 Infection: A Phase 2a Clinical Trial

TypeinterventionalSponsorDenver Health and Hospital AuthorityRan2020 to 2021Enrolled50ConditionsSevere Acute Respiratory Syndrome, Respiratory Failure, Acute Respiratory Distress SyndromeArmsAlteplase 50 MG [Activase]
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 24 citations in OpenAlex.

  1. Trial
  2. COVID-19: A novel holistic systems biology approach to predict its molecular mechanisms (in vitro) and repurpose drugs.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2023
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  6. Article
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  8. Tissue Plasminogen Activator in Critically Ill Adults with COVID-19.Annals of the American Thoracic Society · 2021
    Article
  9. Review
  10. Review
  11. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 1 country.

Hunter B MooreDepartment of Surgery School of Medicine University of Colorado Denver Aurora CO USA.
Christopher D BarrettDepartments of Biological Engineering and Biology Koch Institute for Integrative Cancer Research Center for Precision Cancer Medicine Massachusetts Institute of Technology Cambridge MA USA.ORCID https://orcid.org/0000-0001-9720-8155
Ernest E MooreDepartment of Surgery School of Medicine University of Colorado Denver Aurora CO USA.
Rashi JhunjhunwalaDivision of Acute Care Surgery, Trauma and Surgical Critical Care Department of Surgery Beth Israel Deaconess Medical Center Harvard Medical School Boston MA USA.
Robert C McIntyreDepartment of Surgery School of Medicine University of Colorado Denver Aurora CO USA.
Peter K MooreDepartment of Medicine School of Medicine University of Colorado Denver Denver CO USA.
Janice WangFeinstein Institutes for Medical Research Northwell Health Manhasset NY USA.
Negin HajizadehFeinstein Institutes for Medical Research Northwell Health Manhasset NY USA.
Daniel S TalmorDepartment of Anesthesia, Critical Care and Pain Medicine Beth Israel Deaconess Medical Center Harvard Medical School Boston MA USA.
Angela SauaiaDepartment of Surgery School of Medicine University of Colorado Denver Aurora CO USA.
Michael B YaffeDepartments of Biological Engineering and Biology Koch Institute for Integrative Cancer Research Center for Precision Cancer Medicine Massachusetts Institute of Technology Cambridge MA USA.ORCID https://orcid.org/0000-0002-9547-3251
Beth Israel Deaconess Medical Center · USUniversity of Colorado Denver · USNorthwell Health · USColorado School of Public Health · USDenver Health Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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: A rapidly adaptive, pragmatic, open-label, randomized, controlled, phase IIa clinical trial will be conducted with 3 groups: intravenous alteplase 50 mg, intravenous alteplase 100 mg, and control (standard-of-care). Inclusion criteria are known/suspected COVID-19 infection with PaO Results: The primary outcome is improvement in PaO 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).

Indexed as

acute respiratory distress syndromeclinical trialcoagulopathyCOVID‐19fibrinolysis shutdowntissue‐type plasminogen activator

Identifiers

PMID32838109
PMCPMC7280574
OpenAlexW3027228359

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.