Randomized controlled trial of methylprednisolone versus dexamethasone in COVID-19 pneumonia - Methylprednisolone Vs dexamethasone in COVID-19

niversità degli Studi di Trieste0 个研究点目标入组 680 人开始时间: 2021年3月22日最近更新: 2023年9月11日

适应症

试验速览

暂无简介。

•a)Able to understand and sign the informed consent form
•b)SARS-CoV-2 positive on at least one upper respiratory swab or bronchoalveolar lavage
•c)PaO2 <= 60 mmHg or SpO2 <= 90% or on HFNC, CPAP or NPPV at randomization
•d)Age >= 18 years old at randomization
•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 280
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 400

•a)On invasive mechanical ventilation (either intubated or tracheostomized)
•b)Heart failure as the main cause of acute respiratory failure
•c)On long-term oxygen or home mechanical ventilation
•d)Decompensated liver cirrhosis
•e)Immunosuppression (i.e., cancer on treatment, post-organ transplantation, HIV-positive, on immunosuppressant therapy)
•f)On chronic steroid therapy or other immunomodulant therapy (e.g., azathioprine, methotrexate, mycophenolate, convalescent/hyperimmune plasma)
•g)Chronic renal failure with dialysis dependence
•h)Progressive neuro-muscular disorders
•i)Cognitively impaired, dementia or decompensated psychiatric disorder
•j)Quadriplegia/Hemiplegia or quadriparesis/hemiparesis
•k)Do-not-resuscitate order
•l)Participating in other clinical trial including experimental compound with proved or expected activity against SARS-CoV-2 infection
•m)Any other condition that in the opinion of the investigator may significantly impact with patient’s capability to comply with protocol intervention
•n)Refuse to participate in the study or absence of signed informed consent form.

发起方

niversità degli Studi di Trieste