COVID-19 COVID-19 SARS-CoV2
Conditions
Interventions
Nimotuzumab (Experimental group): Nimotuzumab will be presented in bulbs of 50 mg / 10 mL, boxes of 4 bulbs. Up to three doses of Nimotuzumab will be administered by intravenous route (antecubital vei
Antibodies, Monoclonal, Humanized
Antibodies, Monoclonal
Administration, Intravenous
Nimotuzumab
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.- Any gender and skin color 2.- Age equal to or greater than 19 years 3.- Patients in a severe stage of COVID-19 of the disease defined by any of the following conditions: - Patients who have SpO2 93% or - Patients with a PaO2 / FiO2 ratio 30 inspirations / min, - Patients with infiltrate in more than 50% of both lung fields
Exclusion criteria
Exclusion criteria: 1.- Pregnant or lactating women. 2.-Under 19 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety 1. Serious Adverse Events-SAE (Percentage of patients who developed SAE according to the CTCAE v5.0 classification). Measurement time: During hospitalized time 2. Clinical and laboratory adverse events (The frequency distribution of AD appearance, type of event and body system will be determined. Duration, intensity, result, attitude and causal relationship of the AE will be identified. Measurement time: 0, 24, 48h, 72h, 120h, 168h, 14 days, 21 days y 28 days. Effect: 3. Rate of deceased patients in 14 days following the use of the drug. Measurement time: at 14 days 4. Rate of patients with disease progression (clinical or radiological worsening in the classification of clinical status). Measurement time: 0, 48h, 72h, 120h, 168h, 14 days, 21 days y 28 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pulmonary function (Rate of patients who improve the PO2/FiO2 ratio, Oro-tracheal intubation rate, measured as the rate of patients requiring intubation, Duration of mechanical ventilation or time to deteste, Chest X-ray). Measurement time: 0, 24h, 48h, 72h, 120h, 168h, 14 days, 21 days and 28 days 2. Inflammation Markers (NLR, IL6, Interferon gamma, C-reactive protein). Measurement time: Day 0, at 72 hours, 120 and, 168 hours after the use of the drug. 3. Clinical Laboratory (Hemoglobin (Hb), Total Leukocytes, Neutrophils, Lymphocytes, Platelets, Erythrosedimentation, Triglycerides, Ferritin, Creatinine, LDH (Lactate dehydrogenase), Amino-aspartate transferase, Pyruvic glutamic transferase, Complete Pyruvic Coagulogram, according the lab units). Measurement time: 0, 24h, 48h, 72h, 120h, 168h, 14 days, 21 days and 28 days | — |
Countries
Cuba
Contacts
Public ContactMayra Ramos Suzarte
Center of Molecular Immunology
Outcome results
None listed