RPCEC00000311招募中未知
Treatment of patients with severe SARS-CoV-2 pneumonia with the anti-CD6 monoclonal antibody itolizumab. (COVID-19) - VICTORIA
Center of Molecular Immunology (CIM)0 个研究点目标入组 80 人开始时间: 2020年5月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment
入排标准
- 年龄范围
- 18 years old 至 none（—）
- 性别
- All
入选标准
- •Any gender and skin color
- •Age equal to or greater than 18 years
- •SARS-CoV2 infection diagnosed by PCR-RT or rapid test to the COVID 19 positive
- •Confirmed Multifocal interstitial pneumonia
- •Need for oxygen therapy to maintain saturation of O2>93%
- •Worsening of lung involvement, defined as one of the following criteria:
- •o Worsening oxygen saturation >3 percentage points or decrease in PaO2 >10%, with FiO2 stable in the last 24 hours.
- •o Need to increase FiO2 in order to maintain a stable SO2 or new need for mechanical installation in the last 24 hrs.
- •o Increase in the number and/or extent of consolidation lung areas
- •Express willfulness of the patient, family member or impartial witness
- •Alternatively, itolizumab may be used in patients suspecting macrophage activation syndrome, according to the following criteria:
- •Need for oxygen therapy not less than 6L/min plus one of the following conditions:
- •Wheezing or irregular speech (cannot quickly count to 20 after deep inspiration)
- •Respiratory frequency greater than 22 breaths per minute with oxygen therapy at 6L/min
- •PO2: Partial arterial oxygen pressure <65 mm Hg
- •Worsening of the radiological image
- •Fever = 38oC
- •Reduction of initial values of hemoglobin, platelets or neutrophils or Hb< 90 g/L, platelets <100 x109/L, neutrophils <1 x109/L or leukocytes < 4 x109/L.
- •Decreased erythrocyte sedimentation in mismatch with PCR (low erythrocyte sedimentation and PCR increases or does not change)
- •Increased initial value of triglycerides or triglycerides greater than 3 mmol/L.
- •Increased initial ferritin value from 500 ng/ml or absolute ferritin value = 2000 ng/ml.
- •Transaminase aspartate-aminotransferase =30 IU/L
- •Increase in dimer D
- •Fibrinogen < 2.5 g/L
- •Onset of neurological manifestations
排除标准
- •1.Pregnant and nursing women.
研究者
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