Pneumonia by SARS-CoV-2
Conditions
Interventions
Humanized monoclonal antibody Itolizumab: Treatment protocol for COVID-19 approved by MINSAP+ MAb Itolizumab.
The patient will receive two doses of the MAb Itolizumab, 200 mg each, diluted to 200 mL o
Antibodies, Monoclonal
Antibodies, Monoclonal, Humanized
Administration, Intravenous
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Any gender and skin color 2. Age equal to or greater than 18 years 3. SARS-CoV-2 infection diagnosed by RT-PCR or positive rapid test for COVID 19 4. Confirmed multifocal interstitial pneumonia 5. Need for oxygen therapy to maintain SO2>93% 6. Worsening of lung involvement, defined as one of the following criteria: o Worsening of oxygen saturation >3 percentage points • decrease in PaO2 >10%, • with stable FiO2 in the last 24h. • Need to increase FiO2 in order to maintain stable SO2 • new need for mechanical installation in the last 24 hours. • Increase in the number and/or extension of the pulmonary areas of consolidation. 7. Expresses the voluntariness of the patient, family member or impartial witness. 8. Alternatively, itolizumab may be used in patients in whom macrophage activation syndrome is suspected, according to the following criteria: • Need for oxygen therapy not less than 6L/min plus one of the following conditions: o Wheezing or gasping for breath (cannot quickly count to 20 after taking a deep breath). o Respiratory rate greater than 22 breaths per minute with oxygen therapy at 6L/min PO2. o Partial pressure of arterial oxygen <65 mm Hg. o Worsening of the radiological image. o Fever =38ºC. o Reduction of the 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. o Decreased erythrocyte sedimentation rate in disagreement with CRP (low erythrocyte sedimentation rate and CRP increased or unchanged). o Increase in the initial value of triglycerides or triglycerides greater than 3 mmol/L. o Increase in the initial value of ferritin from 500 ng/ml or absolute value of ferritin = 2000 ng/ml. o Transaminase aspartate-aminotransferase =30 IU/L. o Increased D-dimer o Fibrinogen < 2.5 g/L 9. Appearance of neurological manifestations
Exclusion criteria
Exclusion criteria: Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of lung function decline (Rate of patients without the need to increase FiO2 to maintain stable SO2 and without the need for intubation and/or Rate of patients with decreased positive end-expiratory pressure (PPEP) values) . Measurement time: 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Oro-tracheal intubation rate (Rate of patients requiring intubation). Measurement time: 7 days. 2. Rate of non-invasive or invasive mechanical ventilation when respiratory failure occurs, or failure of non-invasive mechanical ventilation (Rate of patients requiring non-invasive mechanical ventilation (NIMV), Rate of patients requiring invasive mechanical ventilation, Rate of patients with NIMV failure). Measurement time: before, 48, 72, 120 and 168 hours after administering itolizumab 3. Duration time of mechanical ventilation or time until weaning (Time elapsed from the start date of mechanical ventilation to the date of weaning ). Measurement time: until withdrawal of mechanical ventilation 4. Rate of deceased patients (proportion of deceased patients out of the total number of patients included 14 days after being included or once discharged from hospital). Measurement time: 14 days after treatment. 5. Serum concentrations of IL1, IL6 and TNF alpha (reported in pg/ml according to the reference values ??of the commercial kits used). Measurement time: at the beginning, 48, 96 and 168 hours after itolizumab administration. 6. HSH Score (Temperature, visceromegaly, cytopenias, triglycerides, fibrinogen, ferritin, AAT (TGO). Measurement time: 48, 96 and 168 hours after itolizumab administration. 7. C-reactive protein, and absolute count of lymphocytes (positive or negative, qualitative variable) Measurement time: pre, 48 hours, 72, 120 and 168 8. Adverse events related to treatment (according to causality and intensity) Measurement time: pre before administration of the antibody, during and after while the patient is hospitalized 9. Hospitalization time (days in hospital from the date of receiving treatment with Itolizumab until discharge or death in hospital) Measurement time: At discharge or death | — |
Countries
Cuba
Contacts
Public ContactMayra Ramos Suzarte
Center of Molecular Immunology (CIM)
Outcome results
None listed