RPCEC00000380尚未招募未知
Therapeutic proposal of plasmapheresis and the anti-CD6 monoclonal antibody Itolizumab in the treatment of patients with COVID-19. (COVID-19)
Center of Molecular Immunology0 个研究点目标入组 50 人开始时间: 2021年6月30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
- 50
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: Historical. 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. Patients 18 years of age and older
- •4. SARS-CoV-2 infection diagnosed by RT-PCR categorized as moderate high risk or severe and critical patients, presenting any of the following characteristics:
- •- Confirmed multifocal interstitial pneumonia or,
- •- Need for oxygen therapy to maintain SO2> 93% or;
- •- Worsening of lung involvement, defined as one of the following criteria:
- •- Worsening of oxygen saturation> 3 percentage points or decrease in PaO2> 10%, with stable FiO2 in the last 24h.
- •-Need to increase FiO2 in order to maintain a stable SO2 or new need for mechanical installation in the last 24 hours.
- •- Increase in the number and / or extent of lung areas of consolidation.
- •For confirmed cases RT-PCR positive SYMPTOMATIC RT-PCR positive Moderate high risk.
- •Patients with manifestations of infection
- •1-lower respiratory tract WITHOUT signs of severity (mild pneumonia) that are:
- •2-Patients 65 years of age or older; or
- •3- 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).
- •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 suspended, and prophylactic anticoagulant treatment should be indicated in cases that meet the criteria for said therapy).
- •5. Alternatively, Itolizumab can be used in patients with suspected 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 choppy speech (cannot quickly count to 20 after a deep breath)
- •Respiratory rate greater than 22 breaths per minute with oxygen therapy at 6L / min
- •PO2: Partial pressure of arterial oxygen <65 mm Hg
- •Worsening of the radiological image
- •Fever =38ºC
- •Reduction in baseline hemoglobin, platelets or neutrophils oHb <90 g / L, platelets <100 x109 / L, neutrophils <1 x109 / L or leukocytes <4 x109 / L.
- •Decrease in erythrocyte sedimentation in disagreement with C-reactive protein (pcr) (low erythrocyte sedimentation and CRP increases or does not change)
- •Increase in the initial value of triglycerides or triglycerides greater than 3 mmol. / L.
- •Increase in the initial value of ferritin from 500 ng / ml or absolute value of ferritin = 2000 ng / ml.
- •Aspartate aminotransferase transaminase =30 IU / L
- •Increase in D-dimer
- •Fibrinogen <2.5 g / L
- •Appearance of neurological manifestations.
- •In addition, they must meet the specific criteria for the execution of the plasmapheresis procedure;
- •6. Weight of the patient more than 57 kg and height greater than 1.10 m.
- •7. Moderate patients at high risk, whose clinical and laboratory manifestations worsen.
- •8. Neutrophil / lymphocyte ratio> 5, whether or not Itolizumab has been administered
- •9. Coagulation test: Clotting time (5 to 11 minutes)
排除标准
- •1. Pregnant or lactating women.
- •2. Patients under 18 years of age.
- •3. Patients with hypercoagulation
- •4. Cancer patients
- •5. Patients with severe malnutrition, uncontrolled heart disease, patients previously subjected to cardiovascular surgery, with peptic ulcers or upper or lower limb amputation.
研究者
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