Comparison Between Prednisolone and Dexamethasone on D28 Mortality in Patients on Oxygen Therapy, With CoViD-19: Multicenter, Randomized, Open-label Non-inferiority Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 8
- 主要终点
- Mortality assessment at D28
研究概览
简要总结
The aim of the study is to evaluate two differents regimens of corticosteroids (prednisolone versus dexamethasone) on D28 mortality in patients with CoViD 19 pneumonia requiring oxygen supplementation
详细描述
Low-dose glucocorticoid treatment is the only medication showing a significant reduction in mortality in cases of COVID-19 pneumonia requiring oxygen supplementation or ventilatory support.
Intravenous or oral dexamethasone are well evaluated in randomized study but other oral corticosteroids are not. Compared to dexamethasone, prednisolone is more available in France and easily taken by patients, especially in case of home medical care.
The pharmacokinetics/pharmacodynamics of prednisolone and dexamethasone are different. To obtain similar effects, prednisolone should be theoretically taken twice a day and at a superior dose than the strict prednisone equivalence of 6mg dexamethasone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 with SpaO2 ≤ 94 % in room air (90% for patient with respiratory failure) and requiring an oxygen therapy
- •Negative pregnancy test for women of childbearing age
- •Informed and written informed consent (IC) obtained
- •Patients with affiliation to the social security system
排除标准
- •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
研究组 & 干预措施
DEXAMETHASONE Arm
Patients will take 6 mg per day of Dexamethasone during 10 days
干预措施: DEXAMETHASONE (Drug)
PREDNISOLONE Arm
Patients will take 60 mg per day of Prednisolone during 10 days
干预措施: PREDNISOLONE (Drug)
结局指标
主要结局
Mortality assessment at D28
时间窗: At Day 28
Assessment of vital status at D28 in Dexamethason arms vs Prednisolone arms
次要结局
- Assessment of patient satisfaction towards the treatment(At Day 28)
- Comparison betwween D1 and D28 of patient quality of life evolution between randomization groups (arms)(At Day 1 and Day 28)
- Measurement of evolution of respiratory symptoms in both groups (arms)(From Day 0 to Day 28)
- Assessment of clinical course in both groups (arms)(At Day 28)
- Comparison betwween D1 and D28 of adverse events and adverse effects between randomization groups (arms)(At Day 28)