COVID-19 COVID-19 SARS-CoV2
Conditions
Interventions
Itolizumab (Experimental Group): Itolizumab + Plasmapheresis
Itolizumab: A first dose of Itolizumab (humanized anti-CD6 monoclonal antibody) 1.6 mg / kg will be administered by intravenous route. In c
or the relevance of its use can be evaluated, 72 hours after the first dose of Itolizumab has been administered, taking into account the clinical status of the patient and the values ??of the laborato
Antibodies, Monoclonal, Humanized
Antibodies, Monoclonal
Plasmapheresis
Sponsors
Center of Molecular Immunology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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). 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 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 5, whether or not Itolizumab has been administered 9. Coagulation test: Clotting time (5 to 11 minutes)
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1- Recovery rate (The proportion of patients considered recovered will be calculated in relation to the total number of patients who received the therapeutic combination). Measurement time: At hospital discharge. 2- Rate of patients with disease progression (worsening in the classification of clinical status. According to the World Health Organization classification of Moderate, Severe, Critical (Stable, Unstable), any change in status during the evaluation period will be considered Progression). Measurement time: from the first plasmapheresis session at 0, 48h, 72h, 120h, 168h, 14 days, 21 days and 28 days or until hospital discharge or death of the patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1- Intensive care stay time (Time elapsed from admission until discharge from the ICU). Measurement time: At ICU discharge 2- Hospital stay time (Time elapsed from hospital admission until to hospital discharge). Measurement time: At hospital discharge. Lung function: 3- Rate of patients without the need to increase FiO2 to keep SO2 stable (Proportion of patients in whom it is not necessary to increase FiO2). Measurement time: At hospital discharge. 4- Rate of patients who improve the PO2/FiO2 ratio (Rate of patients who increase the PO2/FiO2 ratio). Measurement time: At hospital discharge. 5- Rate of patients requiring non-invasive mechanical ventilation-NIMV (Rate of patients requiring non-invasive mechanical ventilation after starting treatment with the therapeutic combination). Measurement time: At hospital discharge. 6- Rate of patients requiring invasive mechanical ventilation (Rate of patients requiring invasive mechanical ventilation after starting treatment with the therapeutic combination). Measurement time: At hospital discharge. 7- Clinical Adverse Events-AE (From the total number of patients who will receive the therapeutic combination, the percentage that developed serious AE will be calculated, according to the CTCAE v5.0 classification. The type, duration, severity, result and causal relationship of the AE will be recorded). Measurement time: After each dose of therapeutic combination has been administered and during the entire hospitalization period and until hospital discharge. 8- Inflammation Markers (Evaluation of serum concentrations of IL6, Interferon gamma, TNF alpha and Neutrophil / lymphocyte ratio (NLR)). Measurement time: before each plasmapheresis session, immediately after plasmapheresis and 72 hours after plasmapheresis, and up to 72 hours after the last plasmapheresis. 9- Clinical laboratory tests (Evaluation of concentrations of Hemoglobin (Hb), Total leukocytes, Neutrophils, Lymphocytes, Platelets, Erythrosedimentation, C- | — |
Countries
Cuba
Contacts
Public ContactGeidy Lorenzo Monteagudo
Center of Molecular Immunology (CIM)
Outcome results
None listed