COVID-19 respiratory distress COVID-19
Conditions
Interventions
- Patients WITH invasive mechanical ventilation, CIGB-258 Peptide: 1 mg intravenously until extubation of the patient. Subsequently, the same dose and route is continued, every 24 hours, for three day
Peptides
Administration, Intravenous
Peptide CIGB-258,
Jusvinza
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Virological diagnosis by PCR-RT of infection to SARS-CoV-2. 2) Patients with confirmed respiratory distress / multifocal interstitial pneumonia. 3) Need for oxygen therapy to maintain SO2> 93%. 4) Worsening of lung involvement, defined as one of the following criteria: a) Worsening of oxygen saturation > 3 percentage points or decrease in PaO2 > 10%, with stable FiO2 in the last 24 hours; b) Need to increase FiO2 in order to maintain stable SO2 or new need for mechanical ventilation in the last 24 hours; c) Increase in the number and / or extension of the lung consolidation areas. 5) Patients in whom a clinical condition prior to hyperinflammation is suspected, according to the following criteria: a) sustained fever above 38 combined with criteria 2 or 3 and 4; b) dyspnea requiring oxygen therapy by mask or nasal fork, to maintain an oxygen saturation above 93; c) polypnea greater than 25 ventilations per minute, requiring oxygen therapy by mask or nasal fork, to maintain an oxygen saturation above 93; d) choppy language that does not allow you to count to 10. 6) Express voluntariness of the patient, family member or impartial witness.
Exclusion criteria
Exclusion criteria: 1) Known hypersensitivity to any of the components of the formulation. 2) Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of the deterioration of the pulmonary function (Proportion of patients that did not require increasing FiO2 to maintain stable SO2 and without the need for intubation and / or Percentage of patients that decrease the values of positive pressure at the end of expiration [PEEP]). Measurement time: On the 7th day after starting the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Mortality upon discharge from the ICU (proportion of patients who die, according to their causes). Measurement time: during the stay at the Intensive Care Unit. 2) Need and time for mechanical ventilation (Yes, No; time in days elapsed from the start date of ventilation until weaning). Measurement time: During the stay in intensive care, until ventilatory weaning. 3) Measurement of hyperinflammation score parameters (temperature, visceromegaly, cytopenia, triglycerides, aspartate aminotransferase - TGO, fibrinogen, ferritin). Measurement time: at the beginning, at hours 48 and 72, as well as on the 5th and 7th day after starting the treatment. 4) Stay in intensive care-ICU (Time in the ICU from the start of treatment until discharge). Measurement time: during ICU stay. 5) Behavior of biomarkers (Absolute lymphocyte count, C-reactive protein, erythrocyte sedimentation rate, lactate dehydrogenase-LDH and D-dimer). Measurement time: at the beginning, at hours 48 and 72, on the 5th and 7th day. 6) Adverse clinical events-AE (They will be measured as: -Adcurrence of AE [Yes, No], -Description of the AE [name of the event], -Intensity of the AE [mild, moderate, severe], -Relation of causality [no related, doubtful, possible, probable, definitive] -Measures taken [None, Administration of some pharmacological therapy, Addition of a non-pharmacological therapy, Exit of the study, Hospitalization / prolongation of hospitalization], -Result [Fully resolved, Solved with sequelae, Conditions in improvement, Present and unchanged condition, Worsening, Death caused by this event]). Measurement time: daily throughout the period of admission to the ICU. | — |
Countries
Cuba
Contacts
Public ContactVerena Muzio Gonzalez
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed