Steroids and unfractionated heparin in critically-ill patients with pneumonia from COVID-19 infection. A multicenter, interventional, randomized, three arms study design. - Steroids and unfractionated heparin in critically-ill patients with pneumonia from COVID-19 infectio

AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO DI MODENA0 个研究点目标入组 200 人开始时间: 2020年6月26日最近更新: 2021年1月5日

适应症

试验速览

暂无简介。

•- Positive SARS-CoV-2 diagnostic (on pharyngeal swab of deep airways material)
•- Positive pressure ventilation (either non-invasive or invasive) from > 24 hours
•- Invasive mechanical ventilation from < 96 hours
•- P/F ratio < 150
•- D-dimer level > 6 x upper limit of local reference range
•- PCR > 6 fold upper limit of local reference range
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 126
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 84

•- Age <18 years
•- On-going treatment with anticoagulant drugs
•- Platelet count < 100.000/mmc
•- History of heparin-induced thrombocytopenia
•- Allergy to sodium enoxaparine or other LMWH, unfractionated heparin or metylprednisolone;
•- Active bleeding or on-going clinical condition deemed at high risk of bleeding contraindicating anticoagulant treatment
•- Recent (in the last 1 month prior to randomization) brain, spinal or ophthalmic surgery
•- Chronic assumption or oral corticosteroids
•- Pregnancy or breastfeeding or positive pregnancy test. In childbearing age women, before inclusion, a pregnancy test will be performed if not available;
•- Clinical decision to withhold life-sustaining treatment or too sick to benefit”;
•- Presence of other severe diseases impairing life expectancy (e.g. patients are not expected to survive 28 days given their pre-existing medical condition);
•- Lack or withdrawal of informed consent.

发起方

AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO DI MODENA