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临床试验/NCT04374071
NCT04374071已完成不适用

Early Short Course Corticosteroids in Hospitalized Patients With COVID-19

Henry Ford Health System1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2020年3月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
1
主要终点
Transfer to Intensive care unit (ICU)

研究概览

简要总结

The investigators intend to study the role of early use of methylprednisolone in the hospitalized patients with a diagnosis of COVID-19 pneumonia.

详细描述

Consecutive patients hospitalized between March 12, 2020 through March 27, 2020 are eligible for inclusion if they were 18 years of age or older, had confirmed COVID-19 infection, with radiographic evidence of bilateral pulmonary infiltrates, and required oxygen by nasal cannula, high-flow nasal cannula (HFNC), or mechanical ventilation. Patients are excluded if they were transferred from an out-of-system hospital, died within 24 hours of presentation to the ED, or were admitted for less than 24 hours. A confirmed case of COVID-19 was defined as a patient that had a positive reverse-transcriptase-polymerase- chain-reaction (RT-PCR) assay for SARS-CoV-2 in a nasopharyngeal sample.

Patients are risk stratified by severity of symptoms on presentation to the hospital as mild, moderate, or severe COVID-19. Patients without hypoxia or exertional dyspnea were considered to have mild COVID-19. Patients with mild COVID-19 were treated with symptom relief only and not admitted to the hospital. Patients who presented with infiltrates on chest radiography and required supplemental oxygen by nasal cannula or HFNC were classified as having moderate COVID-19. Patients who had respiratory failure requiring mechanical ventilation were classified as having severe COVID-19.

This is a multi-center quasi-experimental study at HFHS, comprised of five hospitals in southeast and south-central Michigan. The study was approved by the institution's Investigational Review Board (#13739) with waiver of consent. Patients in the pre-corticosteroid protocol group from March 12, 2020 through March 19, 2020 were compared to a corticosteroid protocol group that included patients from March 20, 2020 through March 27, 2020.

Patients in both study groups received standard care, comprised of supplemental oxygen, HFNC, invasive ventilation, antibiotic agents, antiviral agents, vasopressor support, and renal-replacement therapy, as determined by the primary team. Patients who progressed to ARDS were managed with standard of care.

Data was ascertained from each institution's electronic medical record and recorded in a standardized electronic case report form. Demographic data, information on clinical symptoms or signs at presentation, and laboratory and radiologic results during admission. All laboratory tests and radiologic assessments, including plain chest radiography and computed tomography of the chest, were performed at the discretion of the treating physician.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • Confirmed COVID-19 infection
  • Radiographic evidence of bilateral pulmonary infiltrates
  • Oxygen requirement by nasal cannula, high-flow nasal cannula (HFNC), or mechanical ventilation

排除标准

  • Transfer from an out-of-system hospital
  • Death within 24 hours of presentation to the ED
  • Admitted for less than 24 hours

研究组 & 干预措施

Corticosteroid Protocol

As a result of observed poor outcomes, clinical rationale based upon immunology, clinical course of COVID-19, and more recently best available evidence, the HFHS corticosteroid protocol was developed. We hypothesized that early corticosteroids would combat the inflammatory cascade leading to respiratory failure, ICU escalation of care, and mechanical ventilation. The corticosteroid protocol became the institutional standard on March 20, 2020. Patients with confirmed influenza infection were not recommended to receive corticosteroids.

Patients with moderate COVID-19 who required 4 liters or more of oxygen per minute on admission, or who had escalating oxygen requirements from baseline, were recommended to receive IV methylprednisolone 0.5 to 1 mg/kg/day in 2 divided doses for 3 days. Patients who required ICU admission were recommended to receive the above regimen of hydroxychloroquine and IV methylprednisolone 0.5 to 1 mg/kg/day in 2 divided doses for 3 to 7 days.

干预措施: Methylprednisolone (Drug)

结局指标

主要结局

Transfer to Intensive care unit (ICU)

时间窗: 14 days followup for every patient in each group

Number of patients transferred to ICU is each of the groups

Need for Mechanical Ventilation

时间窗: 14 days followup for every patient in each group

Number of patients that needed mechanical ventilation in each of the groups

Mortality

时间窗: 14 days followup for every patient in each group

Number of patients who died in each of the groups

次要结局

  • Development and Severity of ARDS(14 days followup for every patient in each group)
  • Length of hospital stay (LOS).(14 days followup for every patient in each group)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mayur Ramesh

Senior Staff Physician, Infectious Diseases

Henry Ford Health System

研究点 (1)

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