RPCEC00000361尚未招募未知
Safety and efficacy of the anti-CD6 itolizumab monoclonal antibody produced in CHO in the treatment of moderate or severe patients with SARS-CoV-2 pneumonia. (COVID-19)
Center of Molecular Immunology(CIM)0 个研究点目标入组 20 人开始时间: 2021年3月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
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 至 one（—）
- 性别
- All
入选标准
- •1. Express voluntariness of the patient, family member or impartial witness.
- •2. Any gender and skin color
- •3. Age equal to or greater than 18 years
- •4. SARS-CoV-2 infection diagnosed by RT-PCR that presents any of the following characteristics:
- •4.1 Confirmed multifocal interstitial pneumonia or,
- •4.2 Need for oxygen therapy to maintain SO2> 93% or;
- •4.3 Worsening of lung involvement, defined as one of the following criteria:
- •4.3.1 Worsening of oxygen saturation> 3 percentage points or decrease in PaO2> 10%, with stable FiO2 in the last 24h.
- •4.3.2 Need to increase FiO2 in order to maintain a stable SO2 or new need for mechanical installation in the last 24 hours.
- •4.3.3 Increase in the number and / or extent of lung areas of consolidation.
- •FOR CONFIRMED CASES RT-PCR positive ASYMPTOMATIC high risk ”which would be:
- •1. Patients 65 years of age or older or;
- •2. or who have any of the risk factors associated with mortality in Covid-19 (obesity, complicated HT, ischemic heart disease, diabetes mellitus, COPD, cancer, kidney failure, severe malnutrition, and others considered by attending physicians).
- •This group will be kept under strict clinical surveillance
- •FOR CONFIRMED CASES RT-PCR positive SYMPTOMATIC RT-PCR positive Moderate high risk”.
- •1. Patients who present manifestations of lower respiratory infection WITHOUT signs of severity (mild pneumonia) that are:
- •1.1 Patients 65 years of age or older; or
- •1.2 Patients who have any of the risk factors associated with mortality in Covid-19 (obesity, complicated HT, ischemic heart disease, diabetes mellitus, COPD, cancer, kidney failure, severe malnutrition, neutrophil / lymphocyte ratio> 4 and others that consider the attending physicians).
- •Important: These cases will be treated in a different room with the supervision of the intensivists. Each case will be evaluated individually. (If the disease has been evolving for 8 days or more, treatment with Heberferon should be discontinued, and prophylactic anticoagulant treatment should be indicated in cases that meet the criteria for such therapy).
- •Alternatively, itolizumab can be used in patients with suspected macrophage activation syndrome, according to the following criteria:
- •1. Need for oxygen therapy not less than 6L / min plus one of the following conditions:
- •1.1 Wheezing or choppy speech (cannot quickly count to 20 after a deep breath)
- •1.2 Respiratory rate greater than 22 breaths per minute with oxygen therapy at 6L / min
- •1.3 PO2: Partial pressure of arterial oxygen <65 mm Hg
- •1.4 Worsening of the radiological image
- •1.5 Fever =38ºC
- •1.6 Reduction in baseline values ??of hemoglobin, platelets or neutrophils or Hb <90 g / L, platelets <100 x109 / L, neutrophils <1 x109 / L or leukocytes <4 x109 / L.
- •1.7 Decrease in erythrocyte sedimentation in disagreement with C-reactive protein (pcr) (low erythrocyte sedimentation and CRP increases or is not modified)
- •1.8 Increase in the initial value of triglycerides or triglycerides greater than 3 mmol. / L.
- •1.9 Increase in the initial value of ferritin from 500 ng / ml or absolute value of ferritin = 2000 ng / ml.
- •1.10 Aspartate aminotransferase transaminase =30 IU / L
- •1.11 Increase in D-dimer
- •1.12 Fibrinogen <2.5 g / L
- •1.13 Appearance of neurological manifestations
排除标准
- •1- Pregnant or nursing women.
- •2- Under 18 years of age.
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