Severe Pneumonia
Conditions
Interventions
Phase 2:
Patients with SCAP will have a treatment schedule according to the assigned group, that is, two dose groups:
Group 1 (experimental). 1 mg, with a treatment schedule for each dose to be studie
Oxygen Inhalation Therapy
Placebos
Administration, Intravenous
Sponsors
Center for Genetic Engineering and Biotechnology (CGIB), the Havana
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with Age = 18 2. Willingness of the patient through the signing of the informed consent. 3. Patients with diagnosis of SACP (Severe Acquired Community Pneumonia).
Exclusion criteria
Exclusion criteria: 1. Patient with Septic Shock. 2. Patient with Severe Acute Respiratory Distress Syndrome. 3. Hospitalized patient with a diagnosis of CAPg of more than 48 hours of evolution. 4. Patient with prior treatment with JAK inhibitor, tocilizumab or other anti-IL6R or IL-6 inhibitor, IL-1 (Anakinra), Nimotuzumab and Itolizumab. 5. Patients with significant deterioration of their underlying chronic disease that compromise imminent survival: diseases such as unresectable tumors, hematological diseases, Alzheimer's disease or AIDS, terminal chronic respiratory diseases requiring permanent oxygenation, prolonged bed rest due to cerebrovascular diseases. 6. Obese patients (Body Mass Index > 30 kg/m2). 7. Patient with Chronic Kidney Disease undergoing hemodialysis. 8. Hypersensitivity to the product or any of its components. 9. Patients with steroid use at immunosuppressive doses greater than 20 mg daily of Prednisone or equivalent. 10. Psychiatric patients. 11. History of SACP 30 days prior to inclusion. 12. Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with improve the respiratory function, measure to the score of respiratory ?SOFA scale (It will be measured through the respiratory ?SOFA scale score. Improved respiratory function: Will be evaluate the response of treatment using the respiratory ?SOFA scale in term of: a) Resolution of the respiratory function as from to diminish the score in 1 or more point. and b) No resolution of the respiratory function as from to the no chance in the score or increase of score or worsenning to severe respiratory distress). Measurement time: It will be measured daily during the treatment of the patient in the Serious Patient Care Unit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Severity Index of Acquired Community Pneumonia (it will be evaluated for each patient included in the study and globally, measured by the sum of patients with treatment evaluation (significantly effective + effective) divided by the total number of patients and multiplied by 100). a) Significantly effective: the severity decreases by two levels, always compared to the result of the previous evaluation. b) Effective: the severe decrees in one level, always compared to the result of the previous evaluation. c) Not effective: not chance or progress to the Severe Respiratory Distress). Measurement time: At the beginning and, on the 10th day of starting treatment, 2. Standardized Mortality Rate (It is the ratio between the number of observed deaths and the number of expected deaths, according to the risk of death calculated by APACHE II. The adjusted or “standardized” rate). Measurement time: At the 10th day of treatment at the time of discharge from the Critical Care Unit. 3. Adverse Events (It will describe type, time, intensity, causal relationship, behavior taken and result). Measurement time: At the beginning, 48 hours, 72 hours, 96 hours, 7th day and 10th day, after to start of treatment 4. Intrahospitalary and discharge mortality (Proportion of severe patients to died (global and by doses), even to cause and groups of treatment). Measurement time: During the hospitalary time or at discharge at 28 days, from to start the treatment with Jusvinza. 5. Necessity and time of non-invasive machanical ventilation and/or oxygen-therapy (Need for oxygen support or non-invasive mechanical ventilation (Yes, No) and time since the patient needs oxygen support or non-invasive mechanical ventilation until the withdrawal of oxygenation or non-invasive mechanical ventilation or until the moment in which the patient requires endotracheal intubation). Measurement time: Upon withdrawal of oxygenation or non-invasive mechanical ventilation or until such time as the patient requi | — |
Countries
Cuba
Contacts
Public ContactJulio Baldomero Hernandez
Center for Genetic Engineering and Biotechnology (CIGB), Havana.
Outcome results
None listed