Steroids and Unfractionated Heparin in Critically Ill Patients With Pneumonia From COVID-19 Infection : Steroids and Unfractionated Heparin in Critically Ill Patients With Pneumonia From COVID-19 Infection. A Multicenter, Interventional, Randomized, Three Arms Study Design

SARS-CoV-2 infection seems to induce in most critical cases an excessive and aberrant hyper-inflammatory host immune response that is associated with a so-called "cytokine storm", moreover pro-thrombotic derangements of haemostatic system is another common finding in most severe forms of COVID19 infections, which may be explained by the activation of coagulative cascade primed by inflammatory stimuli, in line with what is observed in many other forms of sepsis. Targeting inflammatory responses exploiting steroids' anti-inflammatory activity along with thrombosis prevention may be a promising therapeutic option to improve patients' outcome. Despite the biological plausibility, no good evidence is available on the efficacy and safety of heparin on sepsis patients, and many issues have to be addressed, regarding the proper timing, dosages and administration schedules of anticoagulant drugs. The primary objective is to assess the hypothesis that an adjunctive therapy with steroids and unfractionated heparin (UFH) or with steroids and low molecular weight heparin (LMWH) are more effective in reducing any-cause mortality in critically-ill patients with pneumonia from COVID- 19 infection compared to low molecular weight heparin (LMWH) alone. Mortality will be measured at 28 days. The study is designed as a multicenter, national, interventional, randomized, investigator sponsored, three arms study. Patients, who satisfy all inclusion criteria and no exclusion criteria, will be randomly assigned in a ratio 1:1:1 to one of the three treatment groups: LMWH group, LMWH+steroids or UFH+steroid group. A possible result showing the efficacy of the composite treatment in reducing the mortality rate among critically ill patients with pneumonia from COVID-19 infection will lead to a revision of the current clinical approach to this disease..

Medienart:	Klinische Studie

Erscheinungsjahr:	2021
Erschienen:	2021

Enthalten in:	ClinicalTrials.gov - (2021) vom: 06. Mai Zur Gesamtaufnahme - year:2021

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 Communicable Diseases Critical Illness Infection Medical Condition: Covid19, SARS-CoV Infection, Pneumonia, Viral, Coagulopathy Phase: Phase 3 Pneumonia Pneumonia, Viral Recruitment Status: Recruiting Severe Acute Respiratory Syndrome Study Type: Interventional

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: August 27, 2020, Last downloaded: ClinicalTrials.gov processed this data on June 14, 2021, Last updated: June 15, 2021

Study ID:	NCT04528888 Staunch-19-1.1-26-04-20
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PPN (Katalog-ID):	CTG003499758