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临床试验/NCT04382781
NCT04382781Unknown不适用

Effect of Immunosupressive Treatment in COVID-19 Patients Whit SAM-LIKE Profile: Retrospective Cohort Study (SAM-COVID Project)

Spanish Network for Research in Infectious Diseases1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
Invasive ventilation or death

研究概览

简要总结

SAM-COVID is a retrospective cohort study that aims to determine the impact of immunosuppressive drugs and immunoglubulins in the outcome of patients with COVID-19.

详细描述

SAM-COVID is a retrospective cohort study of patients admitted to 66 Spanish hospitals with laboratory-confirmed COVID-19 infection by real-time polymerase chain reaction (RT-PCR) assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) presenting during admission with clinical and laboratory data suggestive of macrophage activation syndrome with the objective to investigate whether the use of immunosuppressive drugs (including high-dose steroids, tocilizumab, sarilumab, anakimra) or immunoglobulins in avoiding the need for invasive mechanical ventilation or in-hospital death.

The Ethics Committee for Research of Virgen Macarena and Virgen del Rocío University Hospitals approved the study and waived the need to obtain informed consent.

The data source was the electronic medical records. All data were entered directly by personnel at each institution using an online case report form (CRF), that satisfied local requirements of data confidentiality.

The variables registered included administrative data, epidemiological information, type of clinical specimen in which the diagnosis was confirmed, demographics, comorbidities and current medications, signs and symptoms at admission, baseline laboratory tests results and at day 0, chest X-ray findings at baseline and during follow-up, medications with potential activity against COVID-19, supportive treatments including oxygen therapy, use of immunosuppressant medications or immunoglobulins, and outcome.

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

  • Adult patients (≥18 years) admitted because of COVID-19 confirmed by PCR in nasopharyngeal swab or lower respiratory tract sample and presenting on a specific date (day 0) one clinical and one laboratory criteria of the following:
  • Clinical criteria:
  • Temperature ≥38ºC.
  • Worsening in oxygen requirements to achieve O2 saturation >92%.
  • Laboratory criteria:
  • Ferritin >2000 ng/mL or increment in >1000 ng/ML since admission.
  • D-dimer >1500 µg/mL (or duplicate in 24h)
  • IL6 >50 pg/mL.

排除标准

  • Mechanical ventilation in day
  • Decision of provide only palliative care before day
  • Use of systemic steroids, tocilizumab, other immunosupressors, or immunoglobulins before day 0.

研究组 & 干预措施

COVID-19 infection

Consecutive patients admitted to Spanish hospitals with laboratory-confirmed COVID-19 infection by real-time polymerase chain reaction (RT-PCR) assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who showed clinical and analytical data suggestive of macrophage activation syndrome during admission until March 30, 2020 .

干预措施: NO-Immunosuppressive (Drug)

COVID-19 infection

Consecutive patients admitted to Spanish hospitals with laboratory-confirmed COVID-19 infection by real-time polymerase chain reaction (RT-PCR) assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who showed clinical and analytical data suggestive of macrophage activation syndrome during admission until March 30, 2020 .

干预措施: Immunosuppressive (Drug)

COVID-19 infection

Consecutive patients admitted to Spanish hospitals with laboratory-confirmed COVID-19 infection by real-time polymerase chain reaction (RT-PCR) assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who showed clinical and analytical data suggestive of macrophage activation syndrome during admission until March 30, 2020 .

干预措施: Immunoglubulins (Drug)

结局指标

主要结局

Invasive ventilation or death

时间窗: Up to 21 days

Days until invasive mechanical ventilation or death, whatever happened first.

次要结局

  • Ventilation(Up to 21 days)
  • Death(Up to 21 days)
  • Secondary infections(Up to 21 days)
  • Digestive tract hemorrhage(Up to 21 days)
  • Change in 7 points scale(Day 21)

研究者

发起方
Spanish Network for Research in Infectious Diseases
申办方类型
Other
责任方
Principal Investigator
主要研究者

JESUS RODRIGUEZ BAÑO

Head of the Infectious Diseases Service of the HU Virgen Macarena

Spanish Network for Research in Infectious Diseases

研究点 (1)

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