Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia: A Randomized, Controlled, 2x2 Factorial Study
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Rate of invasive mechanical ventilation
研究概览
简要总结
The COVID-19 pandemic has been spreading continuously, and in Brazil, until July 19, 2020, there have been more than 2,000,000 cases with more than 79,000 deaths, with daily increases. The present study proposes to evaluate the efficacy of methylprednisolone and heparin in treatment of patients with COVID-19 pneumonia in a randomized, controlled, 2x2 factorial study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Confirmed diagnosis of COVID-19 by RT-PCR or serology with presence of IgM positive antibodies;
- •Lung image (X-ray or chest CT) with involvement of at least 25% of the parenchyma;
- •O2 saturation in ambient air less than or equal to 93%
- •Alteration of inflammatory tests
- •D-Dimer above the reference value and
- •Elevation of C-reactive protein, ferritin or lactic dehydrogenase
- •Sign the consent form.
排除标准
- •QT interval prolongation
- •Imminence of orotracheal intubation (intubation prediction in the first 4 hours after randomization)
- •Women who are pregnant or breastfeeding
- •Corticosteroid allergy or intolerance
- •Chronic corticosteroid users (prednisone equivalent > 10 mg daily)
- •Patients diagnosed with cancer with increased bleeding potential
- •Patients in hemodialysis
- •History of peptic ulcer
- •Herpes zoster infection
- •History or active treatment of tuberculosis
- •Systemic fungal infection
- •Use of anticoagulation due to previous pathology
- •Live virus vaccine up to 90 days before randomization
- •Known coagulopathy or thrombocytopenia (<40,000/mm3) or hypofibrinogenemia (< 50 mg/dL)
- •Recent bleeding
- •Another limiting comorbidity for administering the therapies provided for in this protocol in in researcher's opinion
研究组 & 干预措施
Methylprednisolone + Standard treatment
Participants will receive the standard treatment and methylprednisolone.
干预措施: Methylprednisolone (Drug)
Full-dose heparin + Standard treatment
Participants will receive the standard treatment and full-dose heparin,
干预措施: Heparin (Drug)
Methylprednisolone + Full-dose heparin + Standard treatment
Participants will receive the standard treatment, methylprednisolone and full-dose heparin
干预措施: Methylprednisolone (Drug)
Methylprednisolone + Full-dose heparin + Standard treatment
Participants will receive the standard treatment, methylprednisolone and full-dose heparin
干预措施: Heparin (Drug)
结局指标
主要结局
Rate of invasive mechanical ventilation
时间窗: 28 days
次要结局
- Severity assessment by ordinal severity scale(3 days, 7 days, 14 days, 28 days after randomization)
- Severity assessment by SOFA score(3 days, 7 days, 14 days, 28 days after randomization)
- Length of hospital stay(28 days)
- Length of stay in intensive care(28 days)
- Death rate(14 days, 28 days, 60 days, 90 days after randomization)