NCT04438980已完成3 期
Treatment of COVID-19 Pneumonia With Glucocorticoids. A Randomized Controlled Trial
Fundacion Miguel Servet2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2020年5月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Proportion of patients developing treatment failure
研究概览
简要总结
Around 30% of admitted patients with COVID-19 pneumonia develop a hyper-inflammatory state whose progression to an acute respiratory distress syndrome (ARSD) could be prevented by the early initiation of immune-modulatory agents. The role of glucocorticoids (GC) in this setting remains controversial. This study aims to assess the safety and effectiveness of GC pulses to improve the clinical outcomes of patients with COVID-19 pneumonia with risen inflammatory biomarkers.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old.
- •Diagnosis of SARS-CoV-2 pneumonia confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) on nasopharyngeal swab or sputum according to the recommendations of the Spanish Ministry of Health.
- •Length of symptoms consistent with COVID-19 ≥7 days.
- •Hospital admission.
- •At least one of the following: CRP >60 mg/L, IL-6 >40 pg/mL, ferritin >1000 μg/L.
- •Acceptation of informed consent
排除标准
- •Allergy or contraindication to any of the drugs under study.
- •SpO2 <90% (in air ambient) or PaO2 <60 mmHg (in ambient air) or PaO2/FiO2 <300 mmHg.
- •Ongoing treatment with glucocorticoids, immunosuppressive, or biologic drugs with another indication.
- •Decompensated diabetes mellitus.
- •Uncontrolled hypertension.
- •Psychotic or manic disorder.
- •Active cancer.
- •Pregnancy or lactation.
- •Clinical or biochemical suspicion (procalcitonin >0.5 ng/mL) of active infection other than SARS-CoV-
- •Out-of-hospital management patient.
- •Conservative or palliative management patient.
- •Participation in another clinical trial.
- •Any important and uncontrolled medical, psychological, psychiatric, geographic or social problem that contraindicates the patient's participation in the trial or that does not allow adequate follow-up and adherence to the protocol and evaluation of the study results.
研究组 & 干预措施
Methylprednisolone Arm
Experimental
Standard of care plus Methylprednisolone
干预措施: Methylprednisolone (Drug)
Placebo Arm
Placebo Comparator
Standard of care plus placebo
干预措施: Placebo (Other)
结局指标
主要结局
Proportion of patients developing treatment failure
时间窗: At 14 days after randomization
• Decrease in SpO2 \<90% (in ambient air) or PaO2 \<60 mmHg (in ambient air) or PaO2FiO2 \<300 mmHg, associated with radiological impairment
次要结局
- Proportion of patients requiring rescue-therapy with tocilizumab(At 14 days after randomization)
- Proportion of bacterial, fungal or opportunistic infections(At 28 days after randomization)
- Evolution of inflammatory biomarkers related to COVID-19(At 14 days after randomization)
- Mortality at day 28(At 28 days after randomization)
- Proportion of patients requiring ICU admission(At 28 days after randomization)
- Length of hospital stay(At 28 days after randomization)
- Proportion of severe adverse events(At 28 days after randomization)
- Proportion of SARS-CoV-2 clearance.(At 7 days after randomization)
研究者
研究点 (2)
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