COVID-19 respiratory distress COVID-19 SARS-CoV-2
Conditions
Interventions
Group CIGB-258 peptide: 1 mg intravenously every 12 hours until extubation, followed by the same dose every 24 hours for three days (in patients with mechanical ventilation, where the dose can be incr
Peptides
Administration, Intravenous
Péptido 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) Express voluntariness of the patient, family member or impartial witness.
Exclusion criteria
Exclusion criteria: - Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality on discharge from the ICU (Proportion of patients who die, according to their causes). Measurement time: during the stay in the Intensive Care Unit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Reduction of the deterioration of the lung 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. 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) Immunological response (Determination of serum concentrations of IL-1, IL-6, IL-17 and TNF alpha). Measurement time: at the beginning, at hours 48 and 72, as well as on the 5th and 7th day after starting the treatment. 6) Behavior of prognostic biomarkers (Absolute lymphocyte count, C-reactive protein, erythrocyte sedimentation rate, lactate dehydrogenase - LDH and D-dimer). Measurement time: at baseline, at hours 48 and 72, at the 5th and 7th day. 7) Clinical Adverse Events-AE (They will be measured as: -AE occurrence (Yes, No), -AE description (event name), -AE intensity (mild, moderate, severe), -Causal relationship (unrelated, 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, Resolved with sequelae, Conditions in improvement, Present condition and unchanged, worsening, death caused by this event)). Measureme | — |
Countries
Cuba
Contacts
Public ContactMaria Dominguez Horta
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed