| Autor: |
Dave Singh, John G. Laffey, Jin Yoon, Ruben Barbera, Clive P. Page, Lex van Loon, Antonio Artigas, Carlos Eduardo Sverdloff, Anusha Belani, Alicia Vilaseca, Sabrina Staas, Mary P. Carroll, Marta Camprubí-Rimblas, Khine Sann, Tom Wilkinson, Frank van Haren, Caitlin Sas, Gilberto De Nucci, Tarek I. Ismail, Janis K. Shute, Miles W. Carroll, Barry Dixon, Christopher Hillman, Roger Smith, Thomas Smoot, Mohamed Badr, Rabab S. Mahrous, Alice Richardson, David Cosgrave |
| Rok vydání: |
2020 |
| Předmět: |
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| DOI: |
10.22541/au.160702908.84293841/v1 |
| Popis: |
Introduction Inhaled nebulised unfractionated heparin (UFH) has a strong scientific and biological rationale and warrants urgent investigation of its therapeutic potential for COVID-19. UFH has antiviral effects and prevents the SARS-CoV-2 virus’ entry into mammalian cells. In addition, UFH has significant anti-inflammatory and anti-coagulant properties, which limit progression of lung injury and vascular pulmonary thrombosis. Methods and intervention This meta-trial is a prospective collaborative individual patient data meta-analysis of randomised controlled trials and early phase studies. Individual studies are conducted in multiple countries. Adult patients admitted to the hospital with confirmed SARS-CoV-2 infection, who do not require immediate mechanical ventilation, are randomised to inhaled nebulised UFH or standard care. All studies collect a minimum core dataset. The primary outcome is intubation (or death, for patients who died before intubation) at day 28, assessed in a time-to-event analysis. The secondary outcomes are oxygenation, clinical worsening and mortality, assessed in time-to-event analyses. Individual studies may have specific outcome measures in addition to the core set. Ethics and dissemination: The meta-trial is registered at ClinicalTrials.gov, ID NCT04635241. Results of this study will be shared with the WHO, published in scientific journals and presented at scientific meetings. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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