Steroids and Unfractionated Heparin in Critically Ill Patients With Pneumonia From COVID-19 Infection
Status:
Recruiting
Trial end date:
2021-07-30
Target enrollment:
Participant gender:
Summary
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.