Comparison of Prednisolone and Dexamethasone on D28 mortality in patients on oxygen therapy with CoViD-19 - CoPreDex

Hospital Center rené Dubos0 个研究点目标入组 0 人开始时间: 2020年12月23日最近更新: 2024年1月8日

适应症

试验速览

暂无简介。

•Patient = 18 years old
•Patient with SARS-CoV-2 pneumopathy documented by nasopharyngeal or bronchoalveolar lavage fluid RT-PCR or any documented clinical symptoms support by CT scan
•Patient under supplemental oxygen with a measuring SPO2 = 94 % or = 90 % for patient with respiratory comorbidity
•Informed and written informed consent (IC) obtained
•Patients with affiliation to the social security system
•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 220
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 220

•Patient with corticosteroids as background treatment (= 10 mg equivalent)
•Patient under supplemental oxygen > 6 L/min
•Immunocompromised patient (AIDS, bone marrow or solid organ transplants, etc.)
•Patient who received a corticosteroid dose within 3 days for CoViD-19
•Medical history of hypersensitivity to Prednisolone or Dexamethasone; or lactose / galactose (excipients with known effect)
•Another active virus such hepatitis, herpes, varicella, shingles ….
•Psychotic state not controlled by treatment
•Pregnant and breast-feeding women
•Vulnerable populations (guardianship or trusteeship)
•Taking corticosteroids contraindication (allergy ….)

发起方

Hospital Center rené Dubos