NCT04780581终止4 期
MP3-pulses-COVID-19. Methylprednisolone Pulses Versus Dexamethasone According RECOVERY Protocol in Patients With Pneumonia Due to SARS-COV-2 Coronavirus Infection
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León4 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2021年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 128
- 试验地点
- 4
- 主要终点
- Mortality Rate
研究概览
简要总结
Treatment with glucocorticoids in COVID patients. Low-intervention, phase IV, open-label, randomised, low-intervention clinical trial comparing 2 active treatments.
详细描述
The use of high-dose bolus glucocorticoids in the treatment of patients with COVID-19 infection will increase the anti-inflammatory effect without increasing side effects. This will allow a better patient outcome, reducing the number of deaths and the need for intubation or admission to the Intensive Care Unit.
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
- •Over 18 years of age
- •Diagnosis of SARS-CoV-2 infection confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) or antigen
- •They present evidence in computerized axial tomography (CT) of pulmonary involvement attributed to the infection by COVID. Patients in whom CT scans are not performed must have suspected pulmonary involvement by clinical examination with simple compatible or suggestive radiology.
- •Requires supplementary oxygen due to basal saturation ≤ 93% (with ambient O2, 21%)
排除标准
- •The patient's situation is so serious that the doctor in charge thinks he could die within 24 hours.
- •At the time of randomisation, patients require one of the following 4 ventilatory supports:
- •high-flow oxygen devices.
- •non-invasive mechanical ventilation.
- •invasive mechanical ventilation.
- •Extracorporeal membrane oxygenation (ECMO).
- •The patient is or has been treated in the 2 weeks prior to randomisation with glucocorticoids or inflammation modifying drugs, both conventional (thiopurines, cyclophosphamide, cyclosporine, tacrolimus), leflunomide, methotrexate, mycophenolate mofetil/mycophenolic acid, sulfasalazine, hydroxychloroquine or chloroquine) as synthetics or biologics directed against therapeutic targets (abatacept, belimumab, CD-20, IL1, IL6, Il
- •23, IL-23, Il.17, TNF, integrin α4β7 or Janus kinase inhibitors JAK). Patients who are only on maintenance treatment with doses of steroids less than or equal to 7.5 mg of prednisone or equivalent per day will not be excluded.
- •The patient is pregnant or breastfeeding.
- •The patient has a chronic renal disease is stage 4 or 5 (CCr <30 ml/min).
- •Moderate to severe dementia at the investigator's discretion.
- •Hypersensitivity to any of the active ingredients or to any of the excipients included in its formulation.
- •Untreated systemic infections not caused by COVID-
- •Active stomach or duodenal ulcer.
- •Recent vaccination with live vaccines.
- •Other infection or disease that explains the lung disorder.
- •Inability of the patient to understand the study or to sign the informed consent unless consent is delegated to a legal representative.
- •Active participation in another clinical study in the last 15 days.
研究组 & 干预措施
RECOVERY
Active Comparator
intermediate-dose dexamethasone (6mg/24h - 10 days)
干预措施: Dexamethasone (Drug)
BOLUS
Experimental
high-dose methylprednisolone bolus (250mg/4h - 3 days)
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
Mortality Rate
时间窗: 28 days
Mortality rate (percentage) in COVID-19 patients after high-dose methylprednisolone bolus administration versus mortality rate intermediate-dose dexamethasone pattern (RECOVERY trial)
次要结局
- Admission in Intensive Unit Care (ICU)(28 days)
- Evaluation of Respiratory Support Requirements(28 days)
- Days in Hospital(28 days)
- Evaluation of Presence of Adverse Events Related With Use of High Dose of Glucocorticoids.(28 days)
- Evaluation of Other Immunosuppressors Requirements.(28 days)
- Status According to the World Health Organization (WHO) 10-category Scale.(90 days)
研究者
研究点 (4)
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